Yourlawyer.com (Stroke News) http://www.yourlawyer.com/topics/overview/stroke Sat, 21 Nov 2009 01:13:49 -0800 pixel-app en Beta Blockers Increase Surgery Risk http://www.yourlawyer.com/articles/read/14393 Wed, 14 May 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/14393 A new study on the effects of beta blockers and surgical procedures reveals that patients given a beta blocker—beta blockers are a type of blood pressure drug—to reduce heart risks prior to surgery, were one-third more likely to die within a month and also had double the risk of stroke compared with those who received a placebo, or a dummy pill.  The Canadian study appears in the journal, Lancet.  The study is the largest, most rigorous to date that reviews the effects of beta blockers in reducing surgery-related risks; other, smaller studies provided mixed results.  “There is a real potential that beta blockers are causing serious harm in the surgical setting,” said Dr. P.J. Devereaux of McMaster University in Ontario, who conducted the study.  “If my mother was undergoing surgery and given a beta blocker, I would be extremely upset based on this evidence,” Devereaux added.

It has been long believed that taking a beta blocker prior to major surgery protects the patient from heart risks related to the surgery’s stress.  These new findings challenge that theory.  Surgery often raises levels of a stress hormone known as catecholamine.  Catecholamine increases pressure and heart rates.  “Beta blockers block the effects of increased catecholamines, so the physiological rationale would say they would be beneficial to people,” Devereaux said.
Devereaux and colleagues tested this idea, studying over 8,000 patients in 23 countries at 190 hospitals who were undergoing major surgery unrelated to the heart.  Those studied had or were at risk for clogged arteries.  Half were given the beta blocker metoprolol—sold by AstraZeneca as Toprol XL—two to four hours before and 30 days following surgery.  The other half received a placebo.

The doctors were looking for heart complications such as heart-related death, non-fatal heart attacks, or a heart-stopping event known as cardiac arrest in which the person survived.  The study revealed that those who took the drug had fewer heart attacks and abnormal heart rhythms; however, they were more likely to die or have a stroke.  For every 1,000 people with similar risks undergoing non-cardiac surgery, the drug could prevent 15 people from experiencing heart attack, three from requiring a shock to restore a normal heartbeat, and seven from developing a type of heart rhythm known as atrial fibrillation.

That said, eight more people would die, five would have a stroke, 53 percent would have abnormally low blood pressure, and 42 percent would have an abnormally slow heart beat.  “This is an important study because, although the beta blocker reduced the number of heart attacks that occurred following surgery, it caused more strokes, thus—on balance—causing more harm than good,” Peter Weissberg, medical director of the British Heart Foundation, said.  “This is why it is so important to undertake large clinical trials rather than assuming drugs will only do what is expected of them,” Weissberg added.

Devereaux, initially presented his findings at the November American Heart Association meeting and expects this study to create debate over the wisdom around patients taking beta blockers prior to a major surgery.  “It is telling us something we didn’t realize in the past,” he said.

]]> FDA Asks Novartis to Suspend Marketing of GI Drug Zelnorm http://www.yourlawyer.com/articles/read/12739 Mon, 02 Apr 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12739
Zelnorm was first approved by the FDA in 2002 to treat constipated women with IBS, and the approval was expanded two years later to treat chronic constipation in both men and women younger than 65. However, recent randomized trials conducted by Novartis have called into question the drug’s safety, and the FDA now says that “for most patients the benefits of this drug no longer outweigh the risks.” According to the data, “the risk of serious cardiovascular adverse events (e.g., angina, heart attacks, and strokes) associated with use of Zelnorm is higher than with placebo treatment.”

“This decision reflects the FDA’s commitment to continuously monitor approved drugs throughout their marketing life, and take action when we believe the risks exceed the benefits,” said Dr. Douglas Throckmorton, deputy director for the Center for Drug Evaluation and Research. “Here, a potential risk of very serious harm to patients who have this non-life-threatening condition was recently identified, making this action necessary.”

The FDA recommends that Zelnorm patients who experience severe chest pain, shortness of breath, dizziness, difficulty walking or talking, or other symptoms of a heart attack or stroke should contact their doctors immediately.
]]> Zelnorm is taken off the market http://www.yourlawyer.com/articles/read/12738 Sat, 31 Mar 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12738
Doctors said the voluntary withdrawal of Zelnorm by its manufacturer would leave few options for patients who suffer from a type of irritable bowel syndrome that affects about 12 million Americans, mostly women.

"This is really a sort of one-of-a-kind drug," said Dr. Bennett Roth, chief of gastroenterology at UCLA Medical Center. "It doesn't work for everybody, but in those for whom it works, it gets pretty good results. There are going to be a lot of unhappy patients."

The Food and Drug Administration said it asked for the withdrawal of Zelnorm after an analysis of 29 studies involving more than 18,000 patients found that those who took the medication had significantly higher rates of cardiac problems than those who were given a sugar pill.

Patients taking Zelnorm should call their doctors to discuss alternative treatments, the agency said. Options include laxatives. Any patients who experience chest pain, sudden weakness or other symptoms of heart attack or stroke should immediately go to the emergency room.

The drug's maker, Novartis, said it was complying with the FDA request but did not believe the drug was to blame.

A consultant who reviewed the data for the company said the rates of heart problems in patients taking Zelnorm roughly corresponded with the expected rates in the population.

But Dr. John Jenkins, head of the FDA's Office of New Drugs, said the differences between patients on Zelnorm and those given a sugar pill were significant.

Jenkins said 13 patients taking Zelnorm suffered heart attacks, chest pain or strokes, and one died. Of those taking a sugar pill, one had symptoms of a stroke that went away without further problems. None died.

Although the overall rates of problems were low 0.1% for those taking Zelnorm, compared with 0.01% for those on the sugar pill, the disparity between the two groups got the FDA's attention.

"We found the signal worrisome enough that we thought the benefit of the drug no longer outweighed the risk," Jenkins said.

Zelnorm ranked among the top 200 brand-name prescriptions last year, according to the Internet site drugtopics.com, which monitors the drug industry.

More than 2.6 million prescriptions were written for the medication in 2006, a 25% increase from the previous year.

Novartis said its sales of the drug approached $490 million in 2006. "The product was growing quickly," said spokeswoman Sherry Pudloski. It was approved in the United States in 2002.

Novartis, headquartered in Switzerland, said it would continue talking with the FDA to see whether the medication could remain available to a limited number of patients under tightly controlled conditions. The FDA followed a similar approach a few years ago with another drug for irritable bowel problems, Lotronex.

The discovery of possible heart risks followed a 2004 request from Swiss regulators for a closer look at the data. Novartis submitted the findings to the FDA beginning in February.

Swiss regulators have decided to keep Zelnorm on the market in that country with stronger warnings, Pudloski said. And Novartis is discussing the drug's future in Canada with regulators there.

Peter Lurie, deputy director of Public Citizen's Health Research Group, said his calculations indicated that those taking Zelnorm would face a seven- to eight-fold increase in risk of cardiac problems.

"When you remember that a number of patients taking this drug are younger, otherwise healthy people, the tolerance for serious side effects should be very low, even if they are rare," Lurie said.

Irritable bowel syndrome is estimated to affect up to 20% of Americans, most of whom do not seek treatment. But some patients suffer from continuing bouts of sharp abdominal pains and bloating. About a third have constipation, another third have diarrhea and the remainder alternate between the conditions.

The causes of the syndrome are not fully understood.
]]> Novartis to stop constipation drug sale http://www.yourlawyer.com/articles/read/12733 Fri, 30 Mar 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12733
Novartis agreed to withdraw Zelnorm at the FDA's request, the agency said in a public health advisory.

Zelnorm, also called tegaserod maleate, is a prescription medication approved for short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 with chronic constipation, the FDA said.

Doctors who prescribe Zelnorm should work with their patients and transition them to other therapies as appropriate, the FDA added.

Earlier this year, Novartis gave the FDA the results of new analyses of 29 clinical studies of Zelnorm for treatment of a variety of gastrointestinal tract conditions. The analyses showed 13 of 11,614 patients given Zelnorm had serious and life-threatening cardiovascular side effects, while just one of the 7,031 patients given dummy pills did, the FDA and Novartis said in separate statements.

The FDA has told Novartis it would consider allowing a limited reintroduction of Zelnorm "if a population of patients can be identified in whom the benefits of the drug outweigh the risks," the agency said.

Novartis said it believes the drug provides unique benefits.

"Although we have complied with the FDA's request and are collaborating with the agency, we continue to believe that Zelnorm provides important benefits for appropriate patients," said Dr. Stephen Cunningham, vice president and head of U.S. clinical development and medical affairs for Novartis.

The FDA first approved Zelnorm in 2002.]]> FDA Strengthens Safety Information for Erythropoiesis-Stimulating Agents (ESAs) http://www.yourlawyer.com/articles/read/12645 Fri, 09 Mar 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12645
FDA and the manufacturer of these products have agreed on revised product labeling that includes updated warnings, a new boxed warning, and modifications to the dosing instructions. The new boxed warning advises physicians to monitor red blood cell levels (hemoglobin) and to adjust the ESA dose to maintain the lowest hemoglobin level needed to avoid the need for blood transfusions. Physicians and patients should carefully weigh the risks of ESAs against transfusion risks.

Recently completed studies describe an increased risk of death, blood clots, strokes, and heart attacks in patients with chronic kidney failure when ESAs were given at higher than recommended doses. In other studies, more rapid tumor growth occurred in patients with head and neck cancer who received these higher doses.

In studies where ESAs were given at recommended doses, an increased risk of death was reported in patients with cancer who were not receiving chemotherapy and an increased risk of blood clots was observed in patients following orthopedic surgery.

"The agency is in the process of re-evaluating the safety of Aranesp, Epogen, and Procrit on the basis of the results of recent clinical studies," said Steven Galson, M.D. director of FDA's Center for Drug Evaluation and Research. "The new studies provide significant new information for both prescribers and patients, and the new information applies to all ESAs, which share the same mechanism of action. The safety of these products will be discussed when the Oncologic Drugs Advisory Committee (ODAC) meets in May and further revisions to the labeling may occur after that meeting."

Safety concerns from earlier ESA studies were discussed during a 2004 meeting of the ODAC. Product labeling was previously revised in 1997, 2004, and 2005 to reflect new safety information.

The three drugs are approved to treat anemia in patients with chronic kidney failure and in patients with cancer whose anemia is caused by chemotherapy. Epogen and Procrit are approved for patients scheduled for major surgery to reduce potential blood transfusions and for the treatment of anemia due to zidovudine therapy in HIV patients. ESAs are not approved to treat the symptoms of anemia including fatigue in cancer patients, surgical patients, or those with HIV.

All three drugs are manufactured by Amgen Inc. of Thousand Oaks, California. Procrit is marketed and distributed by Ortho Biotech LP, a subsidiary of Johnson & Johnson.
]]> FDA Warns of Serious Side Effects Related to Popular Anemia Drugs http://www.yourlawyer.com/articles/read/12646 Fri, 09 Mar 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12646
“Recently completed studies describe an increased risk of death, blood clots, strokes, and heart attacks in patients with chronic kidney failure when ESAs were given at higher than recommended doses,” the FDA said. “In other studies, more rapid tumor growth occurred in patients with head and neck cancer who received these higher doses.

“In studies where ESAs were given at recommended doses, an increased risk of death was reported in patients with cancer who were not receiving chemotherapy and an increased risk of blood clots was observed in patients following orthopedic surgery.”

This new labeling change marks the fourth time in the past decade that the products’ label warnings were forced to be updated. “The agency is in the process of re-evaluating the safety of Aranesp, Epogen, and Procrit on the basis of the results of recent clinical studies,” said Dr. Steven Galson, director of FDA’s Center for Drug Evaluation and Research. “The new studies provide significant new information for both prescribers and patients, and the new information applies to all ESAs, which share the same mechanism of action. The safety of these products will be discussed when the Oncologic Drugs Advisory Committee (ODAC) meets in May and further revisions to the labeling may occur after that meeting.”

The FDA is asking the drug makers to add a black-box warning, the agency’s most serious alert, that “advises physicians to monitor red blood cell levels (hemoglobin) and to adjust the ESA dose to maintain the lowest hemoglobin level needed to avoid the need for blood transfusions.”

According to the FDA, ESAs are “genetically engineered forms of the naturally occurring human protein, erythropoietin.” Erythropoietin is produced by the kidneys and increases red-blood-cell levels. Currently, the FDA has approved these drugs for treating anemia in patients with chronic kidney failure and in patients whose anemia is a result of chemotherapy. Combined domestic sales of the three drugs reached approximately $10 billion last year alone.

In January, Amgen sent a letter to medical professionals warning them of an elevated risk of fatalities associated with the use of Aranesp in cancer patients. Amgen conducted a clinical trial to test the safety and efficacy of Aranesp on patients whose anemia was caused by the cancer itself, not by chemotherapy. While the drug is not currently approved for this usage, corporate estimates say that approximately 10 to 12 percent of all Aranesp sales are for that exact off-label (unapproved) usage.

The safety of Epogen has also been questioned by the medical community. Last November, two studies in the New England Journal of Medicine cited the overuse of anemia drugs in the treatment of kidney patients. Scientists have found that anemic kidney patients are susceptible to heart problems or death when aggressively treated with these drugs. Epogen has also been under attack by Congress because of the strain it places on Medicare. Anemia drugs are currently Medicare’s largest drug expenditure.]]> Study: Contraceptive Patch Increases Risk of Blood Clots http://www.yourlawyer.com/articles/read/12605 Mon, 26 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12605
The study looked at more than 98,000 women who’ve used transdermal (patch) contraception and compared them with more than 250,000 women who’ve used oral contraception; the median age was 25. According to the report, “There was a more than two-fold increase in the venous thromboembolism [blood clot] rate among transdermal contraceptive system users compared with oral contraceptives users.” Incidence of stroke and myocardial infarction was too low to produce any meaningful statistical connection.

Ortho-McNeil, makers of the controversial Ortho Evra birth-control patch, continues to deal with significant legal challenges. New York firm Parker & Waichman, LLP, announced in November that it had filed suit in the Superior Court of New Jersey on behalf of a 26-year-old woman who had suffered pulmonary emboli and will be forced to remain on a regimen of anticoagulent medication. The new suit marked the 100th filed by the firm in cases related to the patch.

Last fall, 43 women brought a suit against Ortho-McNeil, a subsidiary of Johnson & Johnson, and San Francisco-based distributor McKesson Corp., alleging that use of the Ortho Evra patch has led to blood clots and other serious health problems. In a separate complaint, plaintiffs want to hold the company responsible for the death of an otherwise healthy 25-year-old woman, Kelly Bracken of Maryland, who suffered fatal blood clots in her lungs and legs after using Ortho Evra. Roughly 400 women have now filed suit against the pharmaceutical company in complaints related to the safety of the patch.

The researchers at i3, a unit of Ingenix, relayed their results to the FDA last September, which led to the institution of new label warnings for the patch. Plaintiffs in the pending suits, as well as some watchdog groups and medical professionals, claim that Ortho-McNeil failed to undertake a comprehensive investigation of the safety of the drug and may have withheld or downplayed potentially damaging information about its side effects during the FDA approval process.

Ortho Evra was approved by the FDA in 2001. According to Parker & Waichman, “Evidence shows that the risk of blood clots, heart attack, and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills…. As of November 2005, the FDA had logged 9,116 reports of adverse reactions to the patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six-year period. During a 12-month period, 44 serious injuries or deaths were associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. The pattern is further magnified when usage rates are considered: Ortho Tri-Cyclen has six times the number of users as Ortho Evra.”
]]> ADHD drugmakers must tell of risks http://www.yourlawyer.com/articles/read/12595 Fri, 23 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12595
The announcement came almost a year after panels of Food and Drug Administration advisers recommended that informational guides be provided to consumers. There are 15 drugs to treat ADHD, including extended-release, patch and chewable versions.

The panels made the recommendation after reviewing reports of young children hearing voices or having hallucinations while on the medications, some reporting they could see snakes or bugs or worms, and there were other reports of heart complications, including sudden death.

An agency review found a slightly increased risk, about one per 1,000 patients for adverse psychiatric reactions. A separate review of reports of serious cardiovascular adverse events found reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors.

The new patient guides would supplement the information already included on the drugs' labeling and would be given out in booklet or pamphlet form with each prescription.

Dr. Mark Epstein, a specialist in the treatment of ADHD and medical director of the Miami Children's Hospital Dan Marino Center in Weston, Fla., said the concerns first surfaced about two years ago and that he got calls from many parents of his patients who take the drugs.

"Parents are very scared when they hear about a risk for sudden death," Epstein said. But after he explained that the risk is no higher for children on the drugs than for the general population, and that the deaths occurred in patients with known heart problems or a family history of such problems, only one or two parents insisted their children be taken off the drugs, he said.

"When the appropriate diagnosis is made and the medications are prescribed properly, they are exceedingly safe," Epstein said, but he recommended that patients and parents talk with their own doctors if they have concerns.

ADHD affects an estimated 3 percent to 7 percent of school-age children and about 4 percent of adults. The three main symptoms are inattention, hyperactivity and impulsivity.]]> Parker Waichman Alonso LLP Believes New Study Confirms Ortho Evra is Associated with Increased Risk of Venous Thromboembolism Compared to Oral Contraceptive Pills http://www.yourlawyer.com/articles/read/12600 Fri, 23 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12600
Parker Waichman Alonso LLP currently represents hundreds of clients who were injured while using the Ortho Evra birth control patch. The firm has cases pending in state and federal courts against Ortho-McNeil Pharmaceutical, Inc, a division of Johnson & Johnson, Inc. (NYSE:JNJ). For more information on Ortho Evra, please visit www.orthopatchlawsuit.com and www.yourlawyer.com/topics/overview/Ortho_Evra_Patch .

It is alleged that Ortho-McNeil was aware of the increased medical risks associated with Ortho Evra before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks. Several studies have revealed that the risk of blood clots, heart attack and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills. The incidence of embolisms and thrombotic injuries in Phase III trials of Ortho Evra was reportedly six times greater than the incidence of such events in oral contraceptives using the hormone levonorgestrel. The FDA has logged 9,116 reports of adverse reactions to the patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six-year period. During a 12-month period, 44 serious injuries or deaths have been associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. The pattern is further magnified when usage rates are considered: Ortho Tri-Cyclen has six times the number of users as Ortho Evra.

About Ortho Evra

Ortho Evra is an adhesive, transdermal birth control patch that users are instructed to apply to their upper torso, upper outer arm, buttock or abdomen. The patch is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream every 24 hours. It is replaced once a week for three weeks, and no patch is worn during the fourth week during menstruation. The regimen is then repeated. Ortho Evra was approved by the FDA in November 2001, and over 4 million women have used Ortho Evra since its approval. Ortho Evra continues to be marketed aggressively to both consumers and physicians.

About Parker Waichman Alonso LLP

Parker Waichman Alonso LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker Waichman Alonso LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. The firm is currently representing individuals injured by Kugel Mesh Hernia Patches, Fosamax, Vioxx, Bextra, ReNu with MoistureLoc, Guidant defibrillators, Risperdal, Seroquel and many other defective drugs and medical products. For more information on Parker & Waichman, LLP, please visit: www.yourlawyer.com or call (800) LAW-INFO.

CONTACT:

Parker Waichman Alonso LLP

David Krangle, Esq.

(800) LAW-INFO

(800) 529-4636

info@yourlawyer.com

www.yourlawyer.com]]> Government wants further ADHD drug warnings http://www.yourlawyer.com/articles/read/12584 Thu, 22 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12584
Patients would receive with their prescriptions two-page "medication guides" that warn about possible side effects and urge them to notify doctors immediately after any sign of heart or psychiatric problems, such as chest pain, shortness of breath, fainting or hallucinations.

Dr. Thomas Laughren of the Food and Drug Administration emphasized that the move was precautionary and should not frighten patients away from taking the drugs, which he said were safe. He expected the manufacturers of the 15 drugs to comply with the request within 30 days.

An estimated 3.3 million children and 1.5 million adults take ADHD drugs, whose sales exceed $3.5 billion a year. Their use has been dogged by concerns about overuse in children and side effects, prompted by scattered reports of children dying suddenly. Some of the children were later determined to have had heart defects.

The latest action expands upon a move the government made last year, when the FDA asked manufacturers to revise ADHD drug labels to alert prospective patients with heart problems and warn of hallucinations in one out of 1,000 children.

Dr. Richard L. Gorman, a pediatrician who served on an FDA advisory panel that recommended the ADHD drug warnings, said the medication guides were "in line with" what the committee recommended. Gorman said parents must pay close attention to their children's reactions to the drugs because children might take them for years.

Laughren said it took until now to work out the wording of the medication guides, which are more simply worded than drug labels. Companies may tweak the language that the FDA proposed, he added.

More than 2,500 children who took ADHD drugs went to emergency rooms in 2004, and about a quarter of them had serious heart or blood pressure problems, the Centers for Disease Control and Prevention reported last year. Twenty-five deaths, 19 involving children, linked to the drugs were reported to the FDA from 1999 to 2003. Fifty-four strokes, heart attacks and other heart issues were also reported; some of those patients had previous heart conditions.]]> Drug makers to add warnings to ADHD pills http://www.yourlawyer.com/articles/read/12581 Wed, 21 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12581
The Food and Drug Administration said Wednesday that it directed the manufacturers of Ritalin, Adderall, Strattera and all other ADHD drugs to develop the guides. In May 2006, the agency told manufacturers to revise the labels of the drugs to reflect concerns about the cardiovascular and psychiatric problems.

Draft versions of the guides posted on the FDA Web site include discussion of reports of increased blood pressure and heart rate in ADHD patients, as well as cases of sudden death in some who have heart problems and heart defects. In adult patients, the reported problems also include stroke and heart attack.

The alerts also cover psychiatric problems, such as hearing voices, unfounded suspicions and manic behavior, of which there is a slightly increased risk in patients who take the drugs, the FDA said. The guides also tell patients and their parents of precautions they can take to guard against the risks.

Wednesday’s announcement came roughly a year after two panels of FDA advisers recommended that the drugs include such patient medication guides. The announcement covers 15 drugs, including extended-release, patch and chewable versions of some of them.

Ritalin is manufactured by Novartis Pharmaceuticals Corp. and in generic form by other companies; Adderall is made by Shire Pharmaceuticals Inc.; Strattera by Eli Lilly & Co.

ADHD affects an estimated 3 percent to seven percent of school-age children and four percent of adults, the FDA said.]]> ADHD Drugs to Get New Warnings http://www.yourlawyer.com/articles/read/12582 Wed, 21 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12582
“Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well,” said Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research (CDER). “In our ongoing commitment to strengthen drug safety, FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new Patient Medication Guides to better inform doctors and patients about these concerns.”

According to the agency, “An FDA review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors. Another FDA review of ADHD medicines revealed a slight increased risk (about 1 per 1,000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.”

In May of 2006, the FDA’s Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee directed the drug makers to revise their label warnings, and the new directive for Patient Medication Guides is the next step in that process. There are 15 medications subject to the new warnings: Adderall, Adderall XR, Concerta, Daytrana, Desoxyn, Dexedrine, Focalin, Focalin XR, Metadate CD, Methylin Oral Solution, Methylin Chewable Tablets, Ritalin, Ritalin SR, Ritalin LA, and Strattera.

The FDA says that approximately 3 percent to 7 percent of children and 4 percent of adults suffer from ADHD, which has three main symptoms: inattention, hyperactivity, and impulsivity. They recommend that any patient considering using any of these drugs “develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems (including assessment for a family history of such problems).”

According to drafts of the medication guides posted on the FDA’s website, the warnings include information about adverse events including “heart-related problems” and “mental (psychiatric) problems.” The heart-related problems cited include sudden death in patients who have heart problems or heart defects; stroke and heart attack in adults; and increased blood pressure and heart rate. The psychiatric problems facing all patients include new or worse behavior and thought problems; new or worse bipolar illness; and new or worse aggressive behavior or hostility. For children and teenagers, there are added warnings about new psychotic symptoms (such as hearing voices, believing things that are not true, unfounded suspicion) or new manic symptoms.]]> FDA orders warning 'guides' for ADHD drugs http://www.yourlawyer.com/articles/read/12585 Wed, 21 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12585
Tom Laughren, director of the FDA's Division of Psychiatry Products, said makers of the 15 products approved to treat ADHD have 30 days to finalize the language in the medication guides. Meanwhile, drafts written by the FDA are posted online at www.fda.gov/cder/drug/ infopage/ADHD/default.htm.

About 3% to 7% of school-age children and about 4% of adults have attention disorders, the FDA says. In 2006, U.S. sales of ADHD drugs totaled about $3.5 billion, according to IMS Health, a health care information company.

Laughren said the new guides reflect changes ordered last May in the warnings section of the drugs' physician labeling. Two FDA advisory committees a year ago recommended adding information about new data on cardiovascular and psychiatric problems in children and teens who took the ADHD drugs.

From 1993 to February 2005, the FDA received 27 reports of unexpected death in patients under 18 who had taken one of the medications, Laughren said. It's not clear whether the deaths were the result of the ADHD drugs or underlying cardiovascular problems, he said.

In addition, since 2000 the agency has received hundreds of reports of psychosis or manic behavior, particularly hallucinations, in patients who had no known risk factors, according to an agency memo given last year to one of the advisory committees.

Also, a pooled analysis of trials that compared an ADHD drug with a placebo found a higher rate of hallucinations, delusions and mania in patients who were given the medication, Laughren said, putting the risk for such problems at one in 1,000 patients.

"Despite this new warning language in the medication guides; we continue to view ADHD as an important illness that benefits from treatment," Laughren said.]]> FDA Directs ADHD Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events and Psychiatric Adverse Event http://www.yourlawyer.com/articles/read/12594 Wed, 21 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12594
"Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well," said Steven Galson, M.D., Director, Center for Drug Evaluation and Research (CDER). "In our ongoing commitment to strengthen drug safety, FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new Patient Medication Guides to better inform doctors and patients about these concerns."

Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides contain FDA-approved patient information that could help prevent serious adverse events. Patients being treated with ADHD products should read the information before taking the medication and talk to their doctors if they have any questions or concerns.

ADHD is a condition that affects approximately 3 percent to 7 percent of school-aged children and approximately 4 percent of adults. The three main symptoms are inattention, hyperactivity, and impulsivity. People with ADHD may have difficulty in school, troubled relationships with family and peers, and low self-esteem.

An FDA review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors.

Another FDA review of ADHD medicines revealed a slight increased risk (about 1 per 1,000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.

FDA recommends that children, adolescents, or adults who are being considered for treatment with ADHD drug products work with their physician or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems (including assessment for a family history of such problems).

As part of the Agency’s ongoing regulatory activity, in May 2006 the FDA directed manufacturers of these products to revise product labeling for doctors to reflect concerns about adverse cardiovascular and psychiatric events. These changes were based on recommendations from the FDA Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee. To help patients understand these risks, an additional part of this revised labeling process is the creation of a Patient Medication Guide for each individual product.

The medicines that are the focus of the revised labeling and new Patient Medication Guides include the following 15 products:
  • Adderall (mixed salts of a single entity amphetamine product) Tablets
  • Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules
  • Concerta (methylphenidate hydrochloride) Extended-Release Tablets
  • Daytrana (methylphenidate) Transdermal System
  • Desoxyn (methamphetamine HCl) Tablets
  • Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
  • Focalin (dexmethylphenidate hydrochloride) Tablets
  • Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
  • Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
  • Methylin (methylphenidate hydrochloride) Oral Solution
  • Methylin (methylphenidate hydrochloride) Chewable Tablets
  • Ritalin (methylphenidate hydrochloride) Tablets
  • Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
  • Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
  • Strattera (atomoxetine HCl) Capsules
]]> Heart surgery drug linked to death risk http://www.yourlawyer.com/articles/read/12506 Wed, 07 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12506
The researchers said replacing the drug aprotinin, sold by Bayer AG under the brand name Trasylol with other, cheaper medications for a year would prevent 10,000 deaths worldwide over the next five years.

The findings were more bad news for Trasylol: The same scientists found the drug raised the risk of kidney failure, heart attacks and strokes in a study published last year. Most of the deaths in the new study were related to those problems.

Bayer said in a statement that the findings are unreliable because Trasylol tends to be used in more complex operations and the researchers' statistical analysis did not fully account for the complexity of the surgery cases.

Nevertheless, the drug company said it will "work with regulatory agencies and external experts in the field to further evaluate the findings."

The study, published in Wednesday's Journal of the American Medical Association, intensifies questions about how best to track the safety of drugs after they have gone on the market. The Food and Drug Administration approved aprotinin in 1993.

Last year's study and other research led the FDA to review Trasylol's safety and order stronger warning labels in December. But that action wasn't strong enough, said Dr. Dennis Mangano of the nonprofit Ischemia Research and Education Foundation, lead author of both studies.

The FDA is already reviewing aprotinin's safety. The new study is an important contribution to that review, which could result in additional warnings, said Dr. Dwaine Rieves, deputy director in the FDA's Division of Medical Imaging and Hematology Products.

The drug works by blocking enzymes that dissolve blood clots, and Mangano speculated that clotting problems caused the deaths.

Mangano advised patients to ask their doctors what drug, if any, they will be given to slow bleeding during heart surgery and about the risks. Past patients should find out if they have been given aprotinin so their doctors can watch for problems, he said.

"I believe that for the vast majority of coronary bypass patients the drug should not be used," Mangano said. But he said the drug should remain on the market because some very high-risk patients may benefit from it.

Dr. Brett Sheridan, a heart surgeon with the University of North Carolina Health Care System who was not involved in the study, said several years ago he quit giving aprotinin almost entirely because he had seen more kidney damage in patients who got the drug.

"It's not a perfect study, but the data are compelling enough that we have to use aprotinin judiciously," Sheridan said of the new research.

The study followed 3,876 patients who had heart bypass surgery at 62 medical centers in 16 nations. Researchers compared patients who received aprotinin to patients who got other drugs or no anti-bleeding drugs. Over five years, 20.8 percent of the aprotinin patients died, versus 12.7 percent of the patients who received no anti-bleeding drug.

When researchers adjusted for other factors, they found that patients who got Trasylol ran a 48 percent higher risk of dying in the five years afterward.

The other drugs, both cheaper generics, did not raise the risk of death significantly.

Cost varies depending on dosage and length of surgery, but a two-hour bypass surgery might require $792 in Trasylol, compared with $7 to $35 for one of the generics.

The study was not a randomized trial, meaning that it did not randomly assign patients to get aprotinin or not. In their analysis, the researchers took into account how sick patients were before surgery, but they acknowledged that some factors they did not account for may have contributed to the extra deaths.

Aprotinin joins the painkiller Vioxx, drug-coated stents and other drugs and devices where safety concerns arose after the products were on the market.

"We don't know enough about what happens with drugs and devices once they go into the public domain," said Dr. Bruce Ferguson of East Carolina University, who wrote an editorial accompanying the new study. Drug companies will have to help pay for a better system of post-market safety research because the government can't afford to do it alone, he said.

Similarly, Mangano said: "I would love to see something change as a result of this."

Last week, FDA officials announced plans to assess safety in the first 18 months a drug is on the market.

The earlier study prompted at least two lawsuits against Bayer, including one from 78-year-old Tennessee resident Ada Williams, who was given the drug during heart surgery in 2004.

"She has to live the rest of her life on dialysis three days a week to keep her alive," said her attorney.]]> International study: Five-year death rate higher in heart surgery patients who are given aprotinin http://www.yourlawyer.com/articles/read/12508 Wed, 07 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12508
Results from an international analysis that focused on a drug called aprotinin, sold under the brand name Trasylol, revealed the risk of death increased by nearly 50 percent in patients given the drug during bypass operations. The medication, made by Bayer AG, was federally approved in 1993.

"I think something radical needs to be done," Dr. Dennis Mangano of the nonprofit Ischemia Research and Education Foundation in San Bruno, Calif., said, calling for a change in how the FDA approves drugs.

As lead investigator of the international research, Mangano found 20.8 percent of patients given aprotinin died of complications, which he said, could be directly traced to the drug. In the control group, only 12.7 percent of patients died. More than 3,800 patients at 62 medical centers in 16 countries were involved in the study.

Aprotinin obstructs the activity of enzymes that dissolve blood clots and thus affects numerous biological pathways involved in clotting. Because it affects so many pathways, Mangano said, the effects of the drug do not diminish after surgery. Vessels throughout the body continue to be affected, including the complex labyrinth of vessels throughout the kidneys. Mangano discovered last year that kidney failure can be a consequence. In this study, he found that patients were vulnerable to heart failure, heart attacks and strokes.

"The thrombosis takes months to years to manifest in death," he said.

In a statement yesterday, Bayer lambasted Mangano's study, which is published in today's issue of the Journal of the American Medical Association. The pharmaceutical giant labeled data in both of Mangano's studies "unreliable." Bayer officials said they "will work with regulatory agencies and external experts in the field to further evaluate the findings."

Even though aprotinin is not a household name, it has been given to an estimated 4 million patients. Not long after its approval, reports of liver toxicity began surfacing, doctors say.

"This is a very important study," said Dr. Stephen Lahey, chief of cardiovascular surgery at Maimonides Medical Center in Brooklyn. He said that while at Harvard University a decade ago, he and colleagues abandoned use of aprotinin after noticing complications.

Issues involving aprotinin are "unbelievably politically charged," Lahey said, "because the company that makes it is a very, very big company and it has a lot of literature saying aprotinin is fine." He was not involved in the research.

Mangano said if surgeons globally used either of two cheaper and less potent medications for a year, 10,000 lives would be spared over five years.]]> Genentech Issues Warning About Eye Drug Lucentis http://www.yourlawyer.com/articles/read/12497 Sat, 27 Jan 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12497
The company announced that preliminary findings from a 5,000-patient trial found that 1.2 percent of patients taking high doses (0.5 mg) of Lucentis suffered a stroke while only 0.3 percent of low-dose (0.3 mg) patients had a stroke. The difference in dosages does not appear to affect the incidence of heart failure.

Genentech has alerted the FDA about their latest findings and does not anticipate the agency making any labeling changes or safety warnings. The Lucentis label already has a warning about blood-clot-related risks such as strokes and heart attacks.

For most patients, the price tag for Lucentis is roughly $10,000 per year. Macular degeneration is the leading cause of blindness in elderly patients, and the drug has become wildly popular as a remedy for vision problems among that population.
]]> Merck Suffers Potential Legal Setback in Vioxx Case http://www.yourlawyer.com/articles/read/12472 Wed, 17 Jan 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12472
The proposed class-action suit seeks to hold Merck financially responsible for coronary testing of former Vioxx patients including those who haven’t yet shown signs of adverse reactions. That group may very well include hundreds of thousands of former Vioxx patients.

Merck pulled Vioxx off the market in 2004 after discovering that the arthritis drug doubled the risks of heart attack and stroke. The company is currently facing more than 27,000 personal-injury lawsuits in addition to 265 potential class-action suits.

The original ruling in the case, now overturned, was handed down by New Jersey Superior Court Judge Carol Higbee. Higbee is still in charge of roughly 15,000 Vioxx-related cases, including two that are going to product-liability trial next week.

If Merck is held responsible for medical monitoring of former Vioxx users, their legal bill may skyrocket. Some estimates have placed the total potential damages as high as $50 billion.]]> Vioxx Decision Upheld, Award Reduced by Texas Court http://www.yourlawyer.com/articles/read/12426 Tue, 26 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12426
Leonel Garza passed away in 2001 after suffering a heart attack that plaintiffs believe was caused by him taking the controversial painkiller Vioxx. This past April, a Texas jury ruled against Merck and awarded the deceased’s family $32 million in damages: $7 million in compensatory damages and $25 million in punitive damages. However, Judge Alex Gabert ruled that the award violated a 2003 state law that set strict limits on punitive and compensatory damages.

Still, the big news for other Vioxx plaintiffs was that the original ruling was upheld, meaning that the courts accepted the premise that even short-term use of Vioxx may have led to severe side effects including heart attacks and strokes. Well more than 27,000 lawsuits have been brought against Merck, which pulled Vioxx from the shelves in September of 2004 after a study disclosed that long-term use of the drug could double a patient’s risk of a coronary event.

However, a New Orleans federal judge rejected appeals by the plaintiffs to form a class action, saying that each individual case was too distinct to be tried as a group. Merck has emerged victorious in the majority of the cases heard to this point.

A financial relationship between Felicia Garza and one of the jurors in the Texas trial has called the legitimacy of the original verdict into question, and Merck plans to seek a new trial because of the alleged improprieties. The lengthy appeals process may delay payment to the Garzas for many years to come.]]> Mother of Tenn. woman sues birth control patch company http://www.yourlawyer.com/articles/read/12366 Tue, 12 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12366
The lawsuit filed in San Francisco Superior Court names Ortho Evra's developer and manufacturer Ortho-McNeil Pharmaceutical Co., a Titusville, N.J.-based subsidiary of Johnson & Johnson; and San Francisco-based distributor McKesson Corp.

Approved by the U.S. Food and Drug Administration in 2001, Ortho Evra is a birth control patch that delivers the hormones estrogen and progestin directly into the bloodstream through the skin.

The lawsuit alleges that Ortho-McNeil knowingly deceived the public about the drug's risk of severe side effects, including stroke, blood clots, deep vein thrombosis and pulmonary embolisms.

The company doesn't comment on ongoing litigation, said Gloria Vanderham, a spokeswoman for Ortho Women's Health and Urology.

Celena Devault, 26 of Hollow Rock, died from a pulmonary embolism and blood clots in June 2003. She had begun using the patch in April 2003.

Celena Devault's mother, Mary Devault, is named as the plaintiff in the lawsuit.

Another lawsuit has been filed on behalf of 55 women suffering from blood clots and other serious illnesses which they allege were caused by the birth-control patch.

"We believe that Ortho-McNeil knew of the dangers of the Ortho patch sold in the U.S. and choose to ignore them," said an attorney, whose firm along with another, filed both suits.

"Patches sold in other countries, including Canada, actually contain a smaller, less dangerous dosage," one of the attorneys  said. "Now, young women across the country are suffering serious illness and even death."

In September, the FDA warned women that their risk of blood clots in the legs and lungs may be higher if they use the Ortho Evra birth control patch instead of the pill. The decision was based on one study showing higher risks for clots, although another study showed no increased risk.

An investigation last year by The Associated Press found that patch users die and suffer blood clots at a rate three times higher than women taking the pill. About a dozen women died in 2004 from blood clots believed linked to use of the patch, the AP reported. Dozens more suffered strokes and other clot-linked problems.]]> FDA Panel Seeks Warning That Stents May Be Unsafe http://www.yourlawyer.com/articles/read/12351 Sat, 09 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12351
Based on the finding, the special 21-member Food and Drug Administration panel recommended that the agency issue new warnings to doctors and patients that the devices' safety has not been established except for relatively low-risk patients, for whom the stents were originally tested and approved.

"If you use the device outside that indication, you're going to have a higher incidence of complications," said William H. Maisel of the Beth Israel Deaconess Medical Center in Boston, who chaired the panel.

The panel stressed that the tiny metal-lattice struts, known as drug-eluting stents, offer advantages over older bare-metal versions for some patients, with the benefits outweighing the risks for the relatively healthy patients for whom the devices have been tested.

It remains unclear whether the devices are causing the complications in other patients; the side effects could be occurring because these patients tend to be sicker. But panel members concluded that until that question can be answered, doctors and patients should be alerted about the potential risks. Several members said they hoped that would make doctors more cautious about using the devices.

"Let's be more judicious about this. Let's be less indiscriminate," said Eric J. Topol of the Scripps Clinic in San Diego.

The panel also recommended that patients who have the stents take anti-clotting drugs for at least a year.

More than 6 million people worldwide have gotten the drug-coated devices, including perhaps 3 million in the United States. At least 800,000 new patients get them each year, making the stents the most common device used to treat heart disease and one of the most common medical procedures of any kind. The panel's recommendations apply to at least 60 percent of those patients.

The FDA is not bound to follow the recommendations, but an official said the agency would respond rapidly.

"There may be things that can be done relatively quickly," the FDA's Daniel G. Schultz said, noting that the warning could take the form of changes in the devices' labels and letters to doctors and patients.

The recommendations came on the second day of a sometimes contentious two-day meeting the FDA urgently convened to determine whether the risks of the devices outweigh the benefits.

The panel concluded that although the devices, compared with older bare-metal versions, may increase the risk of blood clots, drug-eluting stents do not appear to increase the overall risk of heart attacks and strokes when used in the kind of patients for whom they were originally intended. But a majority of patients get them "off-label," or not as intended, and tend to be sicker and have more-complicated conditions, such as diabetes, multiple blockages and blockages in narrower arteries.

In a packed hotel room in Gaithersburg yesterday, the panel listened to presentations from researchers from California, Illinois, North Carolina, Rhode Island, Washington and elsewhere who analyzed the latest data from large registries of patients who had received the stents since they were introduced three years ago. Although the results were mixed, several analyses found an increased risk of blood clots, deaths and heart attacks.

"Do we have evidence that the safety-efficacy balance might be different in the off-label? I think we've heard enough to suggest that that's the case," said Steven Nissen of the Cleveland Clinic.

More than 1 million U.S. heart patients undergo procedures every year to have blocked arteries opened with tiny balloons, after which stents are implanted to keep the vessels open. Scar tissue often grows around the stents, however, narrowing the arteries again and requiring patients to undergo the procedure repeatedly or to have bypass surgery.

The newer stents are coated with a polymer impregnated with drugs that are released slowly, inhibiting scar-tissue growth. Because the devices were shown to be highly effective, they were hailed as a major advance and quickly replaced bare-metal versions for most patients, though the newer stents were tested on and approved for only low-risk patients.

The FDA called for the meeting after studies looking at patients outside tightly controlled clinical trials indicated that a year or more after implantation, patients with drug-coated stents faced increased risks compared with those with bare-metal models. Some researchers have estimated the newer devices might be causing thousands of heart attacks and deaths a year.

Some researchers, along with Boston Scientific Corp. and Johnson & Johnson, which make the two drug-eluting stents sold domestically, say any risks from the devices are offset by the reduced need for repeated procedures and bypass surgery, which carry their own risks.

Patients who get the stents had been advised to take aspirin and the drug Plavix for three to six months to reduce the risk of blood clots. Recent studies have indicated that patients may need to take the drugs longer, perhaps indefinitely. But Plavix is expensive and increases the risk of serious bleeding.]]> Quebec court gives go-ahead for Vioxx suit http://www.yourlawyer.com/articles/read/12253 Sat, 11 Nov 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12253 Quebec is North America's first jurisdiction to allow a consumer class-action lawsuit against Merck & Co. Inc. over its painkiller Vioxx.

On Thursday, Quebec Superiour Court Judge Andre Denis authorized a class-action lawsuit by Quebec residents who suffered "damages caused by the use of the medication" between October 1999 and September 2004.

The number of Quebecers eligible to join the class-action suit isn't clear.

Merck says the class action is open only to Vioxx users who've suffered proven physical injuries because of the drug an interpretation of the term "damages" that would severely limit the number of eligible plaintiffs.

But a lawyer for the plaintiffs argued Quebecers who have suffered monetary "damages" linked to the drug's comparatively high price should also be included an interpretation that would potentially allow thousands of former users to participate.

On Sept. 30, 2004, Merck withdrew Vioxx a nonsteroidal anti-inflammatory drug related to ibuprofen after trial data showed the long-term use of the drug increased the risk of heart attacks and strokes.

Vioxx was used to treat the symptoms of arthritis, painful menstrual cycles and other types of acute pain. Merck has set aside more than $1.2 billion U.S. for Vioxx lawsuits.

On Wednesday, Merck chief executive officer Richard Clark said it could be several years before the company considers settling thousands of Vioxx lawsuits.

A lawyer for plaintiffs in Quebec and Ontario, said there have been more than 20 requests for class-action lawsuits filed across Canada over Vioxx. This is the first Vioxx class-action lawsuit that has received legal clearance to proceed.

Citing statistics by IMS Health Inc., a plantiffs attoreny said Quebecers consumed a disproportionate amount of Vioxx; between 1999 and 2004, 6.3 million prescriptions were written for the drug in Quebec, compared with 15.6 million for all of Canada.

"Given the number of people in Quebec who took Vioxx, it's a significant development," said a palntiffs attorney of the London-Ont. based Siskinds LLP.

The petition for a class action was filed by two plaintiffs, retired teacher Gerald Sigouin and Roger Ste-Marie, a car insurance adjuster. Both men, the court decision said, allege that they suffered heart attacks after using Vioxx for more than three years.

They said Merck "failed in its obligation to adequately inform consumers of (Vioxx's) side effects," a court document shows.

"If the consumers were adequately informed of the inherent risks in taking Vioxx, they wouldn't have taken it, or would have stopped taking it long before."

In his decision, Denis wouldn't allow family members and spouses of Vioxx users to participate in the class action.

Andre Payeur, attorney for Merck Frosst Canada, said the decision was a good one for the company as it limited participants to those who could prove they had been physically harmed by the drug.

"We're talking about very few people," he said.

Payeur defined "damages" as physical harm, as "this is a personal injury claim."

But in a legal squabble that could result in future court delays, plaintiffs attorney  said he defined "damages" as being both physical and monetary.

The plantiffs attorney argued that Merck justified charging more for Vioxx because the company claimed it was safer than other anti-inflammatories on the market. Plaintiffs, he said, could join the class action to seek monetary damages.

"It is surprising to us that Merck is seeking to characterize this as a victory," he said.

It's now up to the plaintiffs to initiate lawsuit proceedings.

Denis's decision isn't the first Vioxx-related class action to proceed in the courts.

In New Jersey, plaintiffs composed of insurance companies were given court authorization for a class action against Merck over the drug. Merck is appealing that decision, Payeur said.

In Quebec, Merck is not permitted to appeal the court's decision.

]]> Heart Stents Reconsidered by Medical Community http://www.yourlawyer.com/articles/read/12356 Wed, 25 Oct 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12356
Recent evidence points to an increased risk of fatal blood clotting associated with a particular type of stent, the drug-coated stent. Drug-coated stents were virtually non-existent as recently as five years ago, but now they command more than 85 percent of the stent market. The FDA has scheduled meetings for this coming December in order to discuss the issue in more detail and perhaps call for further studies.

This week, an FDA official urged Boston Scientific and Johnson & Johnson, the two largest stent producers, to conduct further research into the matter. “The real question is how to expand the knowledge base for many thousands of patients being treated ‘off-label,’” said Bram Zuckerman, director of the FDA’s division for cardiac devices.

The debate over the use of stents has divided the medical community. Most agree that the use of stents–mesh tubes used to hold open clogged arteries–have been instrumental in saving thousands of lives. Beyond that, other questions remain: Are too many doctors recommending the stenting process rather than more traditional treatments such as medication or surgery? Are the more expensive drug-coated stents more dangerous than cheaper non-coated ones? Are the safety risks connected to the method and accuracy of implantation, rather than the product itself?

Several studies this year have pointed to long-term risks of clotting associated with the drug-coated stents in particular. The coated stents are used to prevent tissue from reforming in the arteries. What seems most alarming about them, according to recent studies, is that the risk of clotting has not diminished over time, forcing some patients to remain on anti-clotting medication for extended periods.

Last week, a New England Journal of Medicine study reported that the risk of stroke or death was more than two times higher for patients receiving stents than it was for patients who are treated by endarterectomy (an invasive surgical treatment). That study specifically regarded patients suffering from carotid artery blockage. In a commentary in the same issue of the NEJM, Dr. Anthony J. Furlan said, “The benefits of surgery in reducing the long-term risk of stroke need to be weighed against the immediate risk of death or stroke as a complication of the surgery.” He also said that, based on current FDA guidelines, stenting should be reserved for those patients with a significant (more than 70 percent) blockage who have displayed stroke symptoms and are at a high risk of surgical complications.
]]> Study: Neck stents present stroke risk http://www.yourlawyer.com/articles/read/12188 Wed, 18 Oct 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12188
The study compared the use of stents, small tubes that prop open blood vessels with a common surgical procedure for cleaning out blockages in the carotid artery. Deaths and strokes were more than twice as common in patients treated with stents, the researchers found.

The findings conflict with influential earlier research, which found stents to be safer.

"The jury is still out," said Dr. Anthony Furlan, a vascular neurologist at the Cleveland Clinic.

Furlan wrote an editorial that accompanies the new study, published in Thursday's New England Journal of Medicine.

At issue is the best way to treat patients who develop blockages in the carotid, a key artery that supplies blood to the brain. The blockages are caused by plaque, a cheesy buildup of fat and cholesterol.

Many people with partial blockages do not experience symptoms. But the condition can cause a mini-stroke with temporary symptoms such as loss or blurring of vision in one eye, or weakness or numbness in an arm or leg. If left untreated, a blockage can lead to a major stroke or death.

In the standard treatment, doctors clamp off the artery and clean it out surgically. But that can be risky, especially for patients with heart damage or problems in the other carotid artery.

Doctors developed another treatment, in which they use a catheter to string a wire mesh stent into the artery that expands and props the artery open.

U.S. doctors have been doing carotid stenting since the mid-1990s. But the Food and Drug Administration has approved stenting only in patients who have symptoms from an artery that is blocked 70 percent or more and for whom surgery would be highly risky.

In the new study, French researchers recruited adult patients who had symptoms, a 60 percent or more blockage of the carotid artery, and an average surgery risk. Of the 520 participants, half got surgery and half got stents.

A month after undergoing the procedures, nearly 10 percent of the stented patients suffered death or stroke, versus only 4 percent of the surgical patients.

Here are the numbers: In the stent group, two people died and 23 others suffered a stroke. In the surgical group, three died and seven more suffered stroke.

In contrast, a 2004 U.S. study of patients with high surgery risk found the incidence of death, stroke or heart attack was about 5.5 percent in patients treated with a stent and 10 percent in patients treated with surgery. The difference was attributed to fewer heart attacks in the stent patients.

Some doctors criticized the new study. They noted that initially, the physicians who placed stents did not use an umbrella-like device that is placed beyond the blockage to catch any plaque that breaks off. The 2004 study used the devices.

U.S. standards require use of the device, said Dr. Christopher Cates, an Emory University cardiologist who has performed more than 600 carotid stent procedures.

The researchers strengthened safety guidelines after the study was under way to include the devices, but strokes and deaths had already occurred, Cates said. "That may have been the difference," he said.

The French study also allowed physicians to use a range of different stents, and doctors were not required to have worked with individual products more than twice before, Cates and others said.

A U.S. government-funded study now under way has enrolled 1,472 people. It requires a cerebral protection system and more physician training with the stent used.

"That's our best hope for a more definitive answer," Furlan said.
]]> FDA Statement Regarding New Trasylol Data http://www.yourlawyer.com/articles/read/12156 Fri, 29 Sep 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12156
On September 27, 2006, Bayer Pharmaceuticals told FDA that it had conducted an additional safety study of Trasylol.  The preliminary findings from this new observational study of patients from a hospital database reported that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes.  FDA was not aware of these new data when it held the September 21, 2006, Advisory Committee meeting on Trasylol safety.  FDA is actively evaluating these new data and their implications for appropriate use of the drug.

While FDA conducts its evaluation of this new safety study, we recommend the following to healthcare providers:
  • Physicians who use Trasylol should carefully monitor patients for the occurrence of toxicity, particularly to the kidneys, heart, or brain, and promptly report observed adverse event information to Bayer Pharmaceuticals, the drug manufacturer, or to the FDA MedWatch program, by phone (1-800-FDA-1088), by fax (1-800-FDA-0178), or by the Internet at http://www.fda.gov/medwatch/index.html.
  • Physicians should consider limiting Trasylol use to those situations where the clinical benefit of reduced blood loss is essential to medical management of the patient and outweighs the potential risks.
These recommendations are similar to those provided in a February 8, 2006, FDA Public Health Advisory and information sheets for health care professionals and patients which were based on the published studies mentioned above. See http://www.fda.gov/cder/drug/infopage/aprotinin/default.htm.  

Trasylol works to slow or prevent bleeding, and is used to reduce blood loss and the need for blood transfusion during some types of heart surgeries.  Trasylol is made from the lung tissue of cattle.

In the published studies and the recently supplied Bayer study, patients were not assigned at random to receive various treatments, but rather had their treatment chosen by their physician as part of their standard medical care.  Consequently, in these safety studies, patients receiving Trasylol may have had a higher chance for serious complications to begin with as compared to patients receiving no treatment or treatment with another drug intended to decrease bleeding.  This possibility complicates the assessment of whether the available studies show that Trasylol treatment, rather than other factors, increased the chance for serious kidney or heart complications.

The new study was done for Bayer by a contract research organization.  Existing hospital data from 67,000 records of patients undergoing coronary artery bypass graft surgery were examined.  30,000 of the patients were treated with Trayslol and 37,000 were treated with alternate products.  Using complex epidemiological and statistical methods, the report suggested that patients receiving Trasylol were at increased risk for death, kidney failure, congestive heart failure and stroke.

Healthcare providers and patients are encouraged to report adverse event information to FDA via the MedWatch program by phone (1-800-FDA-1088), by fax (1-800-FDA-0178), or by the Internet at http://www.fda.gov/medwatch/index.html.
]]> GALS' PATCH PERIL http://www.yourlawyer.com/articles/read/12142 Thu, 21 Sep 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12142
The new warnings came months after a manufacturer settled dozens of lawsuits involving the patch and more than two years after a Manhattan fashion student collapsed and died after using one.

The move by the Food and Drug Administration follows a series in The Post which detailed the dangers associated with the trendy contraceptive and uncovered dozens of women who had died or been crippled after wearing the device.

The Post also revealed evidence that the manufacturer's chief researcher was hired in 2000 after faking hormone data in previous scientific studies for another company in the mid-1990s.

The FDA said it updated the label on the Ortho Evra birth-control patch to reflect the results of a recent study that said women using the patch faced twice the risk of clots as women on the pill.

The patch, which is worn on the skin, delivers pregnancy-blocking hormones. It's replaced once a week and is viewed as more convenient than daily pills.

In April, 2004, aspiring model Zakiya Kennedy collapsed on a Midtown subway platform and died from a blood clot in her lung.

The medical examiner blamed the patch, which the 18-year-old had worn briefly.

Kennedy's family filed a multimillion-dollar wrongful-death suit which is still pending against the manufacturer's parent company, Johnson & Johnson, and Mount Sinai Hospital, where a doctor prescribed the patch. They applauded the new label.

"That's a good thing that they updated it," said Kennedy's grandmother, Roberta Alloway. "That should help get the message across that it's a dangerous product."

Alloway said her ultimate goal is to get the product off the market entirely. In the meantime, she said she hopes the new label is easy to read and understand.

"Unfortunately, my granddaughter had to die to bring it to the forefront," Alloway said.

The FDA said it was issuing the updated label despite conflicting results from another study that there was no added risk in using the patch instead of the pill.

"Health-care providers need to balance the risk of higher estrogen exposure with Ortho Evra with the risk of pregnancy if the pill is not taken daily." said Dr. Daniel Shames of the FDA.

Researchers believe estrogen may promote coagulation of the blood, which can result in clots that cause heart attacks or strokes.
]]> Parker & Waichman, LLP Files Lawsuit Against Ortho-McNeil Pharmaceutical, Inc. on Behalf of Ortho Evra Victim - JNJ http://www.yourlawyer.com/articles/read/12194 Tue, 19 Sep 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12194
On August 24, 2004, the injured victim was taken to the emergency room at St. Mary's Medical Center in Wisconsin after experiencing lightheadedness, shortness of breath and chest pain. Diagnostic tests taken at the hospital revealed bilateral pulmonary emboli. The woman was hospitalized and received Heparin and Coumadin anticoagulant therapy. It is likely that the injured woman will need anticoagulant medication for a protracted period of time, potentially for the remainder of her life.

Last month, an epidemiological study provided further evidence that Ortho Evra is unreasonably dangerous and should be recalled from the market. The study found that women using the Ortho Evra birth control patch are twice as likely to develop blood clots compared with those using oral birth control pills. As a result of this study, The Food and Drug Administration updated Ortho Evra's warning language to reflect that women using the patch faced twice the risk of blood clots as compared to women on the pill. The FDA also asked Ortho McNeil to conduct a longer study of the contraceptive patch to evaluate the risks of blood clots, heart attack and stroke.

On November 10, 2005, Ortho McNeil, in conjunction with the FDA, modified its package insert to reflect that users of Ortho Evra are exposed to significantly more estrogen compared with women using oral contraceptives. In the November 10, 2005 label change, Ortho-McNeil admitted for the first time that women who use the patch will be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. The patch is only intended to deliver 20 micrograms of estrogen. The FDA's announcement on this warning can be found at www.fda.gov/bbs/topics/news/2005/NEW01262.html. It is widely understood that increased exposure to estrogen greatly increases the risk of blood clots, which can cause serious injury or death.

Pulmonary embolism is a sudden blockage in a lung artery, usually due to a blood clot that traveled to the lung from the leg, but clots can also form in the pelvic vein. Pulmonary thromboembolism can be fatal or may result in pulmonary arterial obstruction, pulmonary obstruction, pulmonary infarction, chronic pulmonary hypertension, dyspenea and tachypnea. Symptoms may include shortness of breath, difficulty breathing, anxiety, chest pain, fainting and convulsions. Treatment may include long term use of anticoagulant medications and/or surgery. Recent reports have indicated that the risk of developing blood clots, pulmonary thromboembolism, heart attack and stroke may be significantly higher with the Ortho Evra patch than with oral contraceptive use.

It is alleged that Ortho-McNeil was aware of the increased medical risks associated with Ortho Evra before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks. Evidence shows that the risk of blood clots, heart attack and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills. The incidence of embolisms and thrombotic injuries in Phase III trials of Ortho Evra was reportedly six times greater than the incidence of such events in oral contraceptives using the hormone levonorgestrel. The FDA has logged 9,116 reports of adverse reactions to the patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six-year period. During a 12-month period, 44 serious injuries or deaths have been associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. The pattern is further magnified when usage rates are considered: Ortho Tri-Cyclen has six times the number of users as Ortho Evra.

Ortho Evra is an adhesive, transdermal birth control patch that users are instructed to apply to their upper torso, upper outer arm, buttock or abdomen. The patch is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream per 24 hours. It is replaced once a week for three weeks, and no patch is worn during the fourth week during menstruation. The regimen is then repeated. Ortho Evra was approved by the FDA in November 2001, and over 4 million women have used Ortho Evra since its approval. Ortho Evra continues to be marketed aggressively to both consumers and physicians.

About Parker & Waichman, LLP

Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. The firm is currently representing individuals injured by Vioxx, Bextra, Zyprexa, Ketek, ReNu with MoistureLoc, Guidant Defibrillators and many other defective drugs and medical products. For more information on Parker & Waichman, LLP, please visit: www.yourlawyer.com or call (800) LAW-INFO.

More information on this and other class actions can be found on the Class Action Newsline at www.primezone.com/ca.

CONTACT:  Parker & Waichman, LLP
          Jason Mark, Esq.
          Melanie H. Muhlstock, Esq.
          (800) LAW-INFO
          (800) 529-4636
          info@yourlawyer.com
          www.yourlawyer.com]]> Drawbacks of drug-coated stents surfacing http://www.yourlawyer.com/articles/read/12315 Wed, 13 Sep 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12315
The era of the coated devices, which are known technically as drug-eluting stents, was ushered in amid fanfare just three years ago as doctors anticipated a more effective way of treating coronary artery disease. Drug coatings thwart the encroachment of immune system cells that can cause blood vessel scarring and replugging. Coated stents replaced bare metal ones, which left the patient vulnerable to re-blockage.

Two reports in today's New England Journal of Medicine document problems with coated stents, suggesting a return to the bare metal type for some newly diagnosed patients.

Last week a team of European doctors at the World Congress of Cardiology in Barcelona reported problems with dangerous blood clots, which appeared several years after patients had been implanted with a drug-coated device. And Boston Scientific, maker of a stent coated with the cancer drug paclitaxel and sold as the Taxus stent, acknowledged that their own data demonstrates a potential for abnormal clotting with the device.

"This is a classic kind of thing," said Dr. David Brown, chief of cardiovascular medicine at Stony Brook University Medical Center. "Every time we have a technological breakthrough, we invent a new disease along with it. In this case, it's late-stage thrombosis ."

Stenting became an option in the 1980s with the development of bare metal devices. In addition to Taxus, the Cypher stent, by Cordis, a division of Johnson & Johnson is coated with sirolimus, which also beats back cellular forces that lead to re-clogging. An estimated 6 million coated stents have been implanted worldwide

Dr. Steven Nissen, president of the American College of Cardiology and chairman of cardiovascular medicine at the Cleveland Clinic, said it's time to conduct a large-scale clinical trial to determine the risk for heart attacks, strokes and death with the coated devices. He underscored that the clinical trials leading to approval of the devices were not long enough.

"It's all about risks and benefits," Nissen said. "In this case, the late-stage thrombosis with drug-eluting stents is an unintended consequence. We're now beginning to get the big picture."

Even though Nissen told Newsday two years ago that stents would become passe as better drug treatments evolved, he said the newly identified problems are not a sign stents are fading out of favor. "These devices are still very important," in the treatment of heart patients, Nissen said.

Both he and Brown say one way to cope with drug-eluting stents is to extend the amount of time patients are on dual blood-thinning therapy aspirin and the drug Plavix. Even though all heart patients must take aspirin for life, they are weaned from Plavix. Patients with drug-coated stents may have to remain on the drugs longer.

"The decline in bypass surgery nationally occurred as a result of better medical therapy, so I don't think we'll see a shift from a percutaneous treatment to a surgical treatment," Dr. Kevin Marzo, chief of interventional cardiology at Winthrop-University Hospital in Mineola, said.]]> Parker & Waichman, LLP Files Suit Against Ortho-McNeil Pharmaceutical, Inc., Additional Suits to be Filed in Coming Months - JNJ http://www.yourlawyer.com/articles/read/12092 Thu, 24 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12092
On August 24, 2004, the injured victim was taken to the emergency room at Eastern Idaho Regional Medical Center after experiencing headaches, shortness of breath and right anterior pleuritic chest pain. Diagnostic tests taken at the hospital revealed large pulmonary embolus in right upper lobe involving a secondary order vessel that extended into two third order vessels. The woman was hospitalized for six days to receive anticoagulant therapy. It is likely that the injured woman will need anticoagulant medication for a protracted period of time, potentially for the remainder of her life.

On November 10, 2005, Ortho McNeil, in conjunction with the FDA, issued a warning about the increased risks of blood clots associated with Ortho Evra. In the new warning, Ortho-McNeil admitted for the first time that women who use the patch will be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. The patch is only intended to deliver 20 micrograms of estrogen. The FDA's announcement on this warning can be found at www.fda.gov/bbs/topics/news/2005/NEW01262.html. It is widely understood that increased exposure to estrogen greatly increases the risk of blood clots, which can cause serious injury or death.

Pulmonary embolism is a sudden blockage in a lung artery, usually due to a blood clot that traveled to the lung from the leg, but clots can also form in the pelvic vein. Pulmonary thromboembolism can be fatal or may result in pulmonary arterial obstruction, pulmonary obstruction, pulmonary infarction, chronic pulmonary hypertension, dyspenea and tachypnea. Symptoms may include shortness of breath, difficulty breathing, anxiety, chest pain, fainting and convulsions. Treatment may include long term use of anticoagulant medications and/or surgery. Recent reports have indicated that the risk of developing blood clots, pulmonary thromboembolism, heart attack and stroke may be significantly higher with the Ortho Evra patch than with oral contraceptive use.

It is alleged that Ortho-McNeil was aware of the increased medical risks associated with Ortho Evra before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks. Evidence shows that the risk of blood clots, heart attack and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills. The incidence of embolisms and thrombotic injuries in Phase III trials of Ortho Evra was reportedly six times greater than the incidence of such events in oral contraceptives using the hormone levonorgestrel. The FDA has logged 9,116 reports of adverse reactions to the patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six-year period. During a 12-month period, 44 serious injuries or deaths have been associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. The pattern is further magnified when usage rates are considered: Ortho Tri-Cyclen has six times the number of users as Ortho Evra.

Ortho Evra is an adhesive, transdermal birth control patch that users are instructed to apply to their upper torso, upper outer arm, buttock or abdomen. The patch is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream per 24 hours. It is replaced once a week for three weeks, and no patch is worn during the fourth week during menstruation. The regimen is then repeated. Ortho Evra was approved by the FDA in November 2001, and over 4 million women have used Ortho Evra since its approval. Ortho Evra continues to be marketed aggressively to both consumers and physicians.

About Parker & Waichman, LLP

Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. The firm is currently representing individuals injured by Vioxx, Bextra, Zyprexa, Ketek, ReNu with MoistureLoc, Guidant Defibrillators and many other defective drugs and medical products. For more information on Parker & Waichman, LLP, please visit: www.yourlawyer.com or call (800) LAW-INFO.

More information on this and other class actions can be found on the Class Action Newsline at www.primezone.com/ca

CONTACT:  Parker & Waichman, LLP
          Jason Mark, Esq.
          Melanie H. Muhlstock, Esq.
          (800) LAW-INFO
          (800) 529-4636
          info@yourlawyer.com
          www.yourlawyer.com
]]> Merck Suffers 2 Setbacks in Vioxx Cases http://www.yourlawyer.com/articles/read/12068 Thu, 17 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12068
In New Orleans, the jury found that Merck "knowingly misrepresented or failed to disclose" information about Vioxx to retired FBI agent Gerald Barnett's doctors. It said Barnett, of Myrtle Beach, S.C., should get $50 million in compensatory damages. And it added $1 million in punitive damages, saying Merck "acted in wanton, malicious, willful or reckless disregard for the plaintiff's rights."

In New Jersey, state Superior Court Judge Carol Higbee ruled evidence uncovered since the November verdict showed that Merck withheld information showing heart attacks could come with use of Vioxx for less than 18 months, said one of the plantiff attorneys.

The New Jersey attorneys represented Frederick "Mike" Humeston, of Boise, Idaho, who had a heart attack in September 2001.

"Merck consistently said throughout the trial that you had to be on Vioxx for 18 months to be at increased risk of a heart attack, Humeston attorney said. "And that was false. They had data that people were having heart attacks within weeks."

Merck said it would appeal the New Orleans verdict and was considering its options in the New Jersey case.

"Both the finding and the amount of damages were totally uncalled for in this case because Merck acted appropriately in providing information to the medical, scientific and regulatory communities in a responsible and appropriate manner," Kenneth C. Frazier, a senior vice president for Merck, said of the New Orleans verdict.

As for the New Jersey case: "We have a significant disagreement with the court's decision because the evidence presented to the jury during the course of a seven-week trial in 2005 showed that Merck behaved appropriately with respect to Vioxx and also that Vioxx was in no way related to Mr. Humeston's heart attack," Ted Mayer, of Hughes Hubbard & Reed, a member of Merck's national defense team, said in a news release.

Ruling from the bench in Atlantic City, Higbee based her decision on new depositions and an editorial published in the New England Journal of Medicine asserting that Merck withheld "very important heart attack data from the public, and also that they didn't correctly state the data in the trial," Seeger said.

Mayer said the facts behind the editorial "were known to the plaintiff long before the trial, and the jury was aware of the issue because it was presented by the plaintiff's expert."

Mayer also said that the company intended to maintain its policy of trying every Vioxx case.

The lawsuits are among more than 16,000 Vioxx-related suits against Merck in state and federal courts.

David Logan, dean of Roger Williams University School of Law in Bristol, Rhode Island, said the New Orleans verdict would put pressure on Merck to consider settling cases.

"How long can Merck carry the cost of these verdicts?" Logan asked. "None of these cases are coming back small."

He said the cost of litigation and the management time devoted to overseeing the Vioxx cases remove resources that Merck should be spending on developing new products. "This is a drag on Merck going forward," he said. "it is an enormous tax on the company moving forward."

Jon LeCroy, an analyst with Natexis Bleichroeder, said there is no reason for the company to settle and every reason for it to continue to try each case, stretching out the process as long as possible so it doesn't have to dole out a lot of money at once and wearing down plaintiffs so some may go away.

"Clearly it is costing them a lot to fight the cases but that will go up ten fold if they announce a settlement", he said, noting a settlement usually triggers more lawsuits.

Barnett's lawyer, had asked for $25 million in punitive damages, arguing that it would send a message to drugmakers that they should not rush pharmaceuticals to market. Merck's lawyer, Phil Beck, argued that no further awards were needed to punish the drugmaker.

"My guess is that you have already awarded punitive damages. You sent a message loud and clear and the people at Merck heard that message," Beck said.

Outside the courtroom, Barnett said little, only that he was "very happy" with the verdict. Robinson said he was not disappointed with the relatively small punitive award, saying he wanted punitive damages added as a symbolic gesture to deter drug companies from putting unsafe drugs on the market.

On its verdict sheet, the jury had the chance to assign percentages of fault to Merck and various physicians, but assigned blame only to Merck.

The first federal trial had to be held twice. The first jury deliberated 18 hours over three days, but deadlocked over whether Vioxx was to blame for the death of a Florida man who had taken the drug for less than a month. The second jury in that case came back in less than four hours with a verdict for Merck.

In state courts, before Thursday, Merck had won four cases in New Jersey and California. It had lost two cases in Texas and one in New Jersey.

The New Jersey ruling removes one of Merck's state wins.

In federal court, the company now has one win and one loss.

The jurors who decided the Barnett case have at least two things in common with the plaintiff: All eight are men and they're all getting older.

Beck pointed out in closing arguments Wednesday that both are risk factors for heart attacks, and neither can be controlled.
Counsel for Barnett emphasized that his 62-year-old client, who underwent a quintuple bypass after a heart attack at the age of 58, was careful to keep his risks as low as possible with daily exercise, a healthy diet and drugs to control his cholesterol.

He told the jury that the problem was Vioxx, which Barnett took for 31 months before his heart attack in July 2002. He continued to take the painkiller for another two years, stopping one week before Merck pulled it from the market in September 2004, after a study showed it increased the risk of heart attacks and strokes.

Logan said that jurors may have empathized with Barnett. "Plaintiff lawyers want jurors to think `There but for the grace of God goes me.'" he said.]]> Parker & Waichman, LLP Files Suit Against Ortho-McNeil Pharmaceutical, Inc. on Behalf of 36-Year-Old Woman http://www.yourlawyer.com/articles/read/12062 Wed, 16 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12062
On August 25, 2005, the injured woman was taken to the emergency room at Roane Medical Center in Tennessee after experiencing shortness of breath and chest pain. Diagnostic tests taken at the hospital revealed extensive pulmonary emboli bilaterally. The victim was transferred to Methodist Medical Center to receive anticoagulant therapy. It is likely that the injured woman will need anticoagulant medication for a protracted period of time, potentially for the remainder of her life.

On November 10, 2005, Ortho McNeil, in conjunction with the FDA, issued a warning about the increased risks of blood clots associated with Ortho Evra. In the new warning, Ortho-McNeil admitted for the first time that women who use the patch will be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. The patch is only intended to deliver 20 micrograms of estrogen. The FDA’s announcement on this warning can be found at www.fda.gov/bbs/topics/news/2005/NEW01262.html . It is widely understood that increased exposure to estrogen greatly increases the risk of blood clots, which can cause serious injury or death.

Pulmonary embolism is a sudden blockage in a lung artery, usually due to a blood clot that traveled to the lung from the leg, but clots can also form in the pelvic vein. Pulmonary thromboembolism can be fatal or may result in pulmonary arterial obstruction, pulmonary obstruction, pulmonary infarction, chronic pulmonary hypertension, dyspenea and tachypnea. Symptoms may include shortness of breath, difficulty breathing, anxiety, chest pain, fainting and convulsions. Treatment may include long term use of anticoagulant medications and/or surgery. Bilateral pulmonary embolism occurs when blood clots block both pulmonary arteries. Recent reports have indicated that the risk of developing blood clots, pulmonary thromboembolism, heart attack and stroke may be significantly higher with the Ortho Evra patch than with oral contraceptive use.

It is alleged that Ortho-McNeil was aware of the increased medical risks associated with Ortho Evra before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks. Evidence shows that the risk of blood clots, heart attack and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills. The incidence of embolisms and thrombotic injuries in Phase III trials of Ortho Evra was reportedly six times greater than the incidence of such events in oral contraceptives using the hormone levonorgestrel. The FDA has logged 9,116 reports of adverse reactions to the patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six-year period. During a 12-month period, 44 serious injuries or deaths have been associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. The pattern is further magnified when usage rates are considered: Ortho Tri-Cyclen has six times the number of users as Ortho Evra.

Ortho Evra is an adhesive, transdermal birth control patch that users are instructed to apply to their upper torso, upper outer arm, buttock or abdomen. The patch is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream per 24 hours. It is replaced once a week for three weeks, and no patch is worn during the fourth week during menstruation. The regimen is then repeated. Ortho Evra was approved by the FDA in November 2001, and over 4 million women have used Ortho Evra since its approval. Ortho Evra continues to be marketed aggressively to both consumers and physicians.

About Parker & Waichman, LLP

Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. The firm is currently representing individuals injured by Vioxx, Bextra, Zyprexa, Ketek, ReNu with MoistureLoc, Guidant Defibrillators and many other defective drugs and medical products. For more information on Parker & Waichman, LLP please visit: www.yourlawyer.com or call (800) LAW-INFO.

Contact Information
Jason Mark
Esq.
Parker & Waichman, LLP
(800) 529-4636
info@yourlawyer.com]]> Raloxifene averts breast cancer, at a risk http://www.yourlawyer.com/articles/read/11976 Thu, 13 Jul 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11976
Doctors have been testing this drug as an alternative to tamoxifen for preventing breast cancer and as a way to lower heart disease risks.

Based on the new study's results, "most people would decline taking raloxifene" unless they have a high risk of breast cancer, said Dr. Linda Vahdat, director of breast cancer research at Weill Cornell Medical College.

Dr. Marisa Weiss, a Philadelphia breast cancer specialist who founded the consumer Web site breastcancer.org, agreed.

"The cardiac benefit wasn't there. The side effects were," and breast cancer is more treatable than life-threatening blood clots and strokes, she said.

Neither doctor took part in the study, which involved 10,101 postmenopausal women in the United States and 25 other countries. Results were published in Thursday's New England Journal of Medicine.

Many of the authors consult or work for Indianapolis-based Eli Lilly & Co., which makes raloxifene and paid for the study. The drug is sold as Evista for treating the bone disease osteoporosis, but the company is seeking approval to market it for breast cancer prevention.

A similar drug, tamoxifen, has long been used to prevent breast cancers whose growth is fueled by the hormone estrogen. A big federal study reported last month that raloxifene was equally effective at preventing the most serious types of breast cancer and with fewer side effects, although some doctors disagree on how large the differences in side effects really are.

That study, called STAR, directly compared the two drugs in women at higher-than-usual risk of developing breast cancer. The new study involved a different group of women those at high risk of heart problems and tested whether raloxifene was better than dummy pills at reducing breast cancer and heart-related risks.

Participants either had clogged arteries or multiple heart risk factors, such as advanced age, diabetes, smoking, high blood pressure or high cholesterol. About 40 percent also had elevated risk of breast cancer, mostly because of their age, but this was not the main reason they were in this study their heart risk was.

Roughly half were given daily raloxifene pills and the others, dummy pills. Neither they nor their doctors knew who was taking what.

After an average of five years on the pills, deaths and major heart problems were about the same in both groups. Raloxifene users had one-third fewer cases of breast cancer and about half the number of invasive breast cancers benefits seen previously.

However, 59 of the 5,044 raloxifene users had fatal strokes; only 39 of the 5,057 on dummy pills did, translating to a 49 percent greater risk for those taking the drug.

Blood clots in veins, which can be life-threatening if they travel to the lungs, formed in 103 women on raloxifene but only 71 of the others.

The "moderate" breast cancer prevention benefits "do not seem to justify the risks" of raloxifene for women already prone to heart problems, Marcia Stefanick, a disease prevention researcher at Stanford School of Medicine, wrote in an editorial in the medical journal.

However, the murky results make it important for women to talk about risks with their doctors, said Dr. Lori Mosca, one of the authors and director of preventive cardiology at New York Presbyterian Hospital in New York.

"Even though the study overall appears to be a wash, it's important that every woman understand that the tipping point for her may be different. Every woman has a unique risk for breast cancer, for cardiovascular disease," she said.

None of this changes tamoxifen's status as the drug of choice for breast cancer prevention before menopause. Raloxifene's safety and effectiveness in that situation is unknown.
]]> Parker & Waichman, LLP Files Suit Against Ortho-McNeil Pharmaceutical, Inc. on Behalf of Estate of 26-Year-Old Woman Who Died After Using Ortho Evra for 7-1/2 Months - JNJ http://www.yourlawyer.com/articles/read/11979 Thu, 13 Jul 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11979 Parker & Waichman, LLP (www.yourlawyer.com) announced that it has filed suit against Ortho-McNeil Pharmaceutical, Inc., a division of Johnson and Johnson Inc. (NYSE:JNJ), on behalf of the estate of a 26-year-old woman. The decedent died from an acute pulmonary embolism after using the Ortho Evra birth control patch from November 26, 2002 to July 8, 2003. The suit was filed in the United States District Court for the Eastern District of Michigan. For more information on Ortho Evra and this case, please visit www.orthopatchlawsuit.com or www.yourlawyer.com/topics/overview/Ortho_Evra_Patch

On July 8, 2003, the decedent experienced difficulty breathing and collapsed in her home. Paramedics arrived and found the woman in acute respiratory distress. She was taken to the emergency room at St. John Macomb Hospital in Michigan, where emergency room doctors noted she was cyanotic (blue lips and skin) and in severe respiratory distress. The decedent did not respond to CPR and other life-saving measures and was pronounced dead that evening. An autopsy revealed the cause of death as an acute pulmonary embolism.

On November 10, 2005, Ortho McNeil, in conjunction with the FDA, issued a warning about the increased risks of blood clots associated with Ortho Evra. In the new warning, Ortho-McNeil admitted for the first time that women who use the patch will be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen. The patch is only intended to deliver 20 micrograms of estrogen. The FDA's announcement on this warning can be found at www.fda.gov/bbs/topics/news/2005/NEW01262.html . It is widely understood that increased exposure to estrogen greatly increases the risk of blood clots, which can cause serious injury or death.

Pulmonary embolism is a sudden blockage in a lung artery, usually due to a blood clot that traveled to the lung from the leg, but clots can also form in the pelvic vein. Pulmonary thromboembolism can be fatal or may result in pulmonary arterial obstruction, pulmonary obstruction, pulmonary infarction, chronic pulmonary hypertension, dyspenea and tachypnea. Symptoms may include shortness of breath, difficulty breathing, anxiety, chest pain, fainting and convulsions. Treatment may include long term use of anticoagulant medications and/or surgery. Recent reports have indicated that the risk of developing blood clots, pulmonary thromboembolism, heart attack and stroke may be significantly higher with the Ortho Evra patch than with oral contraceptive use.

It is alleged that Ortho-McNeil was aware of the increased medical risks associated with Ortho Evra before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks. Evidence shows that the risk of blood clots, heart attack and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills. The incidence of embolisms and thrombotic injuries in Phase III trials of Ortho Evra was reportedly six times greater than the incidence of such events in oral contraceptives using the hormone levonorgestrel. The FDA has logged 9,116 reports of adverse reactions to the patch in a 17-month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six-year period. During a 12-month period, 44 serious injuries or deaths have been associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period. The pattern is further magnified when usage rates are considered: Ortho Tri-Cyclen has six times the number of users as Ortho Evra.

Ortho Evra is an adhesive, transdermal birth control patch that users are instructed to apply to their upper torso, upper outer arm, buttock or abdomen. The patch is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream per 24 hours. It is replaced once a week for three weeks, and no patch is worn during the fourth week during menstruation. The regimen is then repeated. Ortho Evra was approved by the FDA in November 2001, and over 4 million women have used Ortho Evra since its approval. Ortho Evra continues to be marketed aggressively to both consumers and physicians.

About Parker & Waichman, LLP

Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. The firm is currently representing individuals injured by Vioxx, Bextra, Zyprexa, Ketek, ReNu with MoistureLoc, Guidant Defibrillators and many other defective drugs and medical products. For more information on Parker & Waichman, LLP please visit: www.yourlawyer.com or call (800) LAW-INFO.

More information on this and other class actions can be found on the Class Action Newsline at www.primezone.com/ca

CONTACT:  Parker & Waichman, LLP
          Jason Mark, Esq.
          Melanie H. Muhlstock, Esq.
          (800) LAW-INFO
          (800) 529-4636, Toll-free
          info@yourlawyer.com
          www.yourlawyer.com

]]> Ibuprofen doubles the risk of a heart attack http://www.yourlawyer.com/articles/read/11817 Fri, 02 Jun 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11817  
The drug is one of the most widely used remedies for headaches, period pains and discomfort caused by inflammation.
 
It is used by millions of arthritis sufferers on a daily basis to relieve painful joints.
 
But researchers warned people yesterday not to remove the drug from household medicine cabinets.
 
There was no danger for occasional users and the benefits of the drug for patients who depend on it to lead normal lives were still likely to outweigh its risks, they said.
 
The study is the largest and most definitive of its kind into the effect of non-steroidal anti-inflammatory drugs (NSAIDs) on the heart, involving 138 trials covering 140,000 patients.
 
It follows concern over a separate group of anti-inflammatories known as the Cox-2 inhibitors which led to the withdrawal of Vioxx in 2004 after it was linked with an increased rate of heart attacks.
 
Vioxx , made by Merck, is now the subject of a series of multimillion dollar lawsuits from patients who suffered heart attacks which they claim were caused by the drug.
 
Now confirmation that drugs such as Ibuprofen, which the Cox-2 inhibitors were designed to replace, also carry an increased risk of heart attack puts the risks of Vioxx in a different light.
 
The Coxib drugs have fewer side effects on the gut than the NSAIDs such as Ibuprofen, which are prone to cause gastrointestinal bleeding, and some researchers are questioning whether Vioxx should have been withdrawn.
 
Scientists from the Clinical Trial Service Unit at the University of Oxford, with colleagues from the University of Rome, carried out the study published in the British Medical Journal.
 
They combined results from all trials of the two classes of drug in order to provide the most reliable estimate of the increased risk.
 
Two drugs from among the NSAIDs ibuprofen and the prescription-only diclofenac increased the risk of a heart attack by almost as much as the Coxib drugs, but a third drug, naproxen, did not.
 
The researchers say most of the patients in the trials did not have pre-existing heart disease and the increased risk was modest, amounting to three extra heart attacks in every 1,000 people taking Ibuprofen or diclofenac every year.
 
The two drugs had a lesser effect on the stroke rate.
 
Overall they increased the risk of any vascular event heart attack or stroke by 40 per cent.
 
Colin Baigent, of the Medical Research Council, who directed the research, said: "That is a relatively low risk for someone who can't get out of bed in the morning because their body is racked with pain. What we have demonstrated is that both the NSAIDs and the Coxibs have the same kind of risks but it is for doctors to discuss those risks with their patients."
 
He added: "For those on smaller doses the supposition must be that the risks are lower. The advice has always been to take the lowest dose for the shortest time necessary to control symptoms. People who are popping these for the odd headache, the risks to them are minimal."
 
Dr Baigent said the scare over Vioxx had been overdone.
 
"There was a worry at the time that this particular drug was to blame [for the increase in heart attacks] and it was withdrawn. Probably all these drugs are associated with some hazard but they control pain very effectively. We have to decide which drug is best for each patient. This debate has been ill informed and a bit hysterical."
 
A spokeswoman for Arthritis Care said 9 million people in the UK suffered from arthritis and "millions" were taking high doses of pain killers on a regular basis.
 
"This is a patient choice issue. All drugs have side effects but patients taking large doses are in a lot of pain. They have to weigh up the possibility of an enjoyable life against something else."
 
Reckitt Benckiser, which makes Nurofen a non-prescription ibuprofen-based pain reliever, stressed the BMJ study did not look at their drug, only at higher dose prescription drugs.
 
Zephanie Jordan, at Reckitt Benckiser, said: "Ibuprofen is a highly effective pain medicine that has been used safely in more than 50 countries worldwide and by millions of people.
 
"There is a considerable body of scientific evidence illustrating the safety and efficacy of ibuprofen when used at low doses and for short term use."
]]> Study: ADHD drugs send thousands to ERs http://www.yourlawyer.com/articles/read/11766 Wed, 24 May 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11766
Scientists at the U.S. Centers for Disease Control and Prevention estimated problems with the stimulant drugs drive nearly 3,100 people to ERs each year. Nearly two-thirds overdoses and accidental use could be prevented by parents locking the pills away, the researchers say.

Other patients had side effects, including potential cardiac problems such as chest pain, stroke, high blood pressure and fast heart rate.

Concerns over those effects have led some doctors to urge the Food and Drug Administration to require a "black box," its most serious warning, on package inserts for drugs such as Ritalin, Concerta and Adderall. Yet even doctors advising the FDA don't agree on whether that's warranted.

The issue was discussed in a series of letters in Thursday's New England Journal of Medicine, including some from doctors worried about the dangers of not treating attention deficit hyperactivity disorder.

"The numbers (of side effects) are puny compared to the numbers of stimulant prescriptions per year," said Dr. Tolga Taneli, a child and adolescent psychiatrist at University of Medicine and Dentistry of New Jersey in Newark. "I'm not alarmed."

An estimated 3.3 million Americans who are 19 or younger and nearly 1.5 million ages 20 and older are taking ADHD medicines. Ritalin is made by Novartis Pharmaceuticals Corp. of East Hanover, N.J.; Concerta by Johnson & Johnson of New Brunswick, N.J., and Adderall by Shire US Inc. of Newport, Ky.

Twenty-five deaths linked to ADHD drugs, 19 involving children, were reported to FDA from 1999 through 2003. Fifty-four other cases of serious heart problems, including heart attacks and strokes, were also reported. Some of the patients had prior heart problems.

Still, there hasn't been a clear estimate of the scope of side effects. The CDC report, while not a rigorous scientific study, attempts to provide that by using a new hospital surveillance network.

From August 2003 through December 2005, the researchers counted 188 ER visits for problems with the drugs at the 64 hospitals in the network, a representative sample of ERs monitored to spot drug side effects.

Doctors linked use of stimulant ADHD drugs to 73 patients with side effects or allergic reactions. Another 115 accidentally swallowed ADHD pills, including a month-old baby, or took too much.

"These are cases where a young child took someone else's medication or they took too much of their own," CDC epidemiologist Dr. Adam Cohen said of the second group.

Nearly 1 in 5 patients was admitted to the hospital, 1 in 5 needed stomach pumping or treatment with medicines, and 1 in 7 had cardiac symptoms. Sixteen percent of the side effects involved interaction with another drug.

Besides cardiac problems, common symptoms included abdominal pain, rashes and spasms, pain or weakness in muscles, according to Cohen. No patients died.

Extrapolating to all U.S. hospitals, the researchers estimated 3,075 ER visits occur each year.

In another letter in the journal, the heads of the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry wrote they are concerned a black box warning would discourage use of ADHD drugs, raising patients' risks of academic failure, substance abuse and other problems.

This past February, an FDA drug safety advisory panel voted 8-7 for a black box warning. The next month, another FDA panel instead recommended data on cardiac and other risks go in a new "highlights" section the agency plans to add to the top of drug inserts.

Dr. Marsha Rappley, pediatrics professor at Michigan State University, and two other doctors on the advisory panels believe the vote for a black box was premature.

She said studies show the drugs raise blood pressure and pulse rates a bit, but it's unknown whether that would harm children taking them for years, and that cardiac risks may be higher for adults.

Dr. Steven Nissen, cardiology chief at the Cleveland Clinic, who had pressed for a black box warning at the FDA panel meeting, said ADHD drugs are powerful stimulants and inherently risky. Nissen and other doctors say the drugs are being prescribed to some who don't need them.

This week, the FDA said it is "working diligently" on "labeling changes that we feel accurately reflect the available data and the advice of the committees." The agency declined interview requests.
]]> Health Canada advises consumers not to use weight loss products containing ephedrine and caffeine http://www.yourlawyer.com/articles/read/11761 Tue, 23 May 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11761
Two particular products pose potential health risks, WestPharm Hydro-Lean capsules, and a combination of 4Ever Fit ephedrine and caffeine pills.

Canadians suffering from heart conditions, high blood pressure and diabetes are among those particularly at risk.

WestPharm Hydro-Lean has not been assessed by Health Canada for safety, effectiveness or quality and is not authorized for sale in Canada. It is, however, distributed through the Internet and may have been brought into Canada either by personal importation or other means. Health Canada is working with the Canada Border Services Agency to prohibit further importation of this product.

The 4Ever Fit ephedrine and caffeine pills are packaged in separate bottles, but are sold together in a Convenience Pack. Ephedrine and caffeine are authorized in Canada as separate products, but they are not authorized to be sold or taken in combination. 4Ever Fit Convenience Pack has been recalled from retail stores by the Canadian distributor, 4Ever Fit, due to the risk of serious and potentially fatal effects.

When used in combination with caffeine and other stimulants, ephedrine has caused reported adverse events ranging from dizziness, tremors, headaches and irregularities in heart rate to seizures, psychosis, heart attacks and stroke. One report of an adverse reaction suspected to be related to the use of Hydro-Lean has been reported to Health Canada. The symptoms in this case included an elevated heart rate and general discomfort.

All individuals who have used WestPharm Hydro-Lean or the ephedrine and caffeine tablets in the 4Ever Fit Convenience Pack, or any other products containing ephedrine and stimulants such as caffeine, should stop consuming them. Such products should not be used for weight loss, increased energy, body building or any other purpose.

Consumers who believe they have experienced adverse effects from taking these products should consult their health care practitioner.

Both ephedra and ephedrine are authorized by Health Canada for use only as a nasal decongestant in over-the-counter cold products. All such authorized products carry an eight-digit Drug Identification Number (DIN) or Natural Product Number (NPN) on the label and should be used only as directed, for short periods of time. Currently, the maximum allowable dosage for ephedrine is 8 mg in a single dose or 32 mg per day. The maximum allowable dosage for ephedra is 400 mg in a single dose or 1,600 mg per day.

Consumers should avoid using unauthorized products that contain ephedra or ephedrine in combination with caffeine or other stimulants because of the health risk. As a source of ephedrine, the label on these products may list: ma huang, Chinese ephedra, ma huang extract, ephedra, Ephedra Sinica, ephedra extract, ephedra herb powder, Sida Cordifolia or epitonin. As a source of caffeine or other stimulants, the label on these products may list: green tea, guarana, yerba mate, cola nut and yohimbine.
]]> Vioxx risk may have begun in 4 months http://www.yourlawyer.com/articles/read/11731 Fri, 19 May 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11731
The company disputed that yesterday, saying it is "not scientifically appropriate" to draw conclusions based on a key graph in a 108-page report.

The news, first reported by National Public Radio, comes after prominent doctors said last week that Merck misrepresented other data from the same study.

Merck officials said last week that data from a follow-up a year after patients stopped taking Vioxx showed the risk ended soon after patients stopped taking it and that those who later had such complications had no legitimate lawsuit. But several doctors said they think the data instead showed that the heart and stroke risks persisted for at least a year.

The newly public data show the increased cardiovascular risk likely begins as early as four to six months and then increases, said Dr. Steven Nissen, a Cleveland Clinic cardiologist who heads a huge international study of painkiller safety.

"It didn’t really make a lot of sense that nothing happened for 18 months and then all of a sudden you would see a hazard," Nissen said yesterday.

Other doctors concurred.

Because few heart attacks and strokes occurred, Nissen said scientists can’t definitively say the painkiller caused the excess complications in the Vioxx group compared with those in the placebo group, but most would interpret it that way.

"There’s no 18-month delay until you see harm," said Dr. Curt Furberg, professor of public health science at Wake Forest University School of Medicine in Winston-Salem, N.C.

"You’re probably at risk the rest of your life," he added.

The study, known by the acronym APPROVe, included 2,586 patients, with half taking Vioxx and half dummy pills for three years. When the company first published APPROVe data, in February 2005 in The New England Journal of Medicine, it only included complications within 14 days of stopping the drug, even if patients stopped early. A key graph showed higher risk after 18 months.
]]> New data noted on Vioxx risk http://www.yourlawyer.com/articles/read/11722 Thu, 18 May 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11722
The Journal says new company data suggest the cardiovascular risk begins within four months of Vioxx use, and not 18 months as the company has said.

The Journal cited a graph in a new one-year follow-up of patients. It said the graph tracking the number of "confirmed thrombotic cardiovascular events" indicated those occurring in Vioxx patients began to outpace those on a placebo by the fourth month of the study.

Merck said the data "do not establish that the risk for Vioxx starts earlier than had previously been reported," the newspaper said. Merck said for the first 18 months of the trial, the relative risk in the new analysis was similar to the old study. The Journal report said the company didn't give additional explanation about the graph. Merck withdrew the pill from the market in September 2004.

The Journal report said the company did not comment on whether the new report has been submitted to the Food and Drug Administration.]]> Merck data suggests earlier onset of Vioxx risks http://www.yourlawyer.com/articles/read/11723 Thu, 18 May 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11723
The data suggest that cardiovascular risks increase for Vioxx users after four months of use, rather than 18 months as the company had previously said, according to the Wall Street Journal.

Merck initially withdrew Vioxx from the market in September 2004, citing data from a study called Approve that showed an uptick in incidences of "confirmed thrombotic cardiovascular events" after 18 months, said the report.

But a new summary of follow-up data finds that Vioxx patients had an increased risk after only four months, according to the Journal.

In a graph from the earlier study, the lines tracking events among Vioxx patients and placebo takers diverged after 18 months, rather than four, said the Journal.

In a statement, Merck said that the data "do not establish that the risk for Vioxx starts earlier than had previously been reported," said the report.

Around 11,500 lawsuits have been filed against Merck by Vioxx patients alleging heart complications from taking Vioxx, said the Journal.]]> Study: Vioxx Risks Started Within Months http://www.yourlawyer.com/articles/read/11727 Thu, 18 May 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11727
The company disputed that Thursday, saying it is "not scientifically appropriate" to draw conclusions based on a key graph in a 108-page report on the data.

The news, first reported by National Public Radio, comes after prominent doctors said Merck misrepresented other data from the same study late last Thursday.

Merck officials said last week that data, from a follow-up of patients a year after they stopped taking Vioxx, showed heart and stroke risk ended soon after patients stopped taking it and that patients who later had such complications didn't have a legitimate lawsuit. But several doctors told The Associated Press they believe the data instead shows the heart and stroke risks persisted for at least a year.

The newly public data show the increased cardiovascular risk with Vioxx use likely begins as early as four to six months and then gets bigger, said Dr. Steven Nissen, a Cleveland Clinic cardiologist who heads a huge international study of the risks of several other painkillers.

"It didn't really make a lot of sense that nothing happened for 18 months and then all of a sudden you would see a hazard," Nissen said Thursday.

Other doctors concurred.

Because a small number of heart attacks and strokes occurred, Nissen said scientists can't definitively say the painkiller caused the excess complications in the Vioxx group compared to those in the patient group taking a placebo, but most would interpret it that way.

"There's no 18-month delay until you see harm," said Dr. Curt Furberg, professor of public health science at Wake Forest University School of Medicine.

"This has implications for patients and all the legal cases that are under way," he said, adding, "You're probably at risk the rest of your life."

The study, known by the acronym APPROVe, included 2,586 patients, with half taking Vioxx and half dummy pills for three years. Patients were enrolled in the study from February 2000 to November 2001.

By September 2004, Merck said it was clear the Vioxx group had about twice as many heart attacks and strokes, leading the Whitehouse Station, N.J.-based company to pull the drug from the market then. As lawsuits over Vioxx have topped the 11,500 mark, Merck has insisted there was no increased risk from Vioxx until 18 months a key argument in its legal strategy.

"The new APPROVe data do not establish that the risk for Vioxx starts earlier than had been previously reported," Merck repeated Thursday in a statement. Merck declined to provide a company official to answer questions on the record.

When the company first published data on the APPROVe study, in February 2005 in the New England Journal of Medicine, it only included complications suffered by patients within 14 days of stopping the drug, even if they stopped early. A key graph in that report didn't show higher risk until after 18 months.

That's not the proper way to report studies, said Dr. Alastair Wood, professor of pharmacology and medicine at Vanderbilt University. He said that method would exclude complications suffered by patients who stopped taking Vioxx early because of side effects such as rising blood pressure, then had a heart attack more than two weeks later.

If Merck knowingly excluded those complications, he said, "that's outrageous."

"It's a 'Let's hope the referee isn't looking' kind of thing," Wood said.

The complete data follow about 85 percent of the patients throughout the full study, producing a different picture, with risk rising within months.

A key graph and two related tables in the new 108-page report, which Merck supplied to The Associated Press, seem to indicate that within three or four months, a higher risk of heart complications began for patients in the Vioxx group. The tables show that over the first six months, the Vioxx group had about a 60 percent higher chance of having a heart attack or stroke.

The risk to the Vioxx group bounces around over the following months, as is common in clinical studies with small numbers of complications, then rises after 18 months' use, reaching up to 12 1/2 times higher from 30 to 36 months.

Merck has already submitted the 108-page report to the Food and Drug Administration, which has said only that it is reviewing the new data. A spokeswoman did not immediately return messages Thursday.

Of the six Vioxx lawsuits that have reached verdicts, Merck has lost three, with multimillion dollar jury awards in each case.]]> Data: Vioxx Heart Risks Began Earlier than Thought http://www.yourlawyer.com/articles/read/11739 Thu, 18 May 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11739
In a confidential report to the Food and Drug Administration (FDA) last week, Merck gave new details about a large Vioxx study known by the acronym APPROVe. Results from this study led Merck to pull Vioxx from the market in 2004, and were later published in the New England Journal of Medicine (NEJM).

The new report details more heart problems. Several of the new events occurred in Vioxx patients soon after they started taking the drug.

Clinical trial expert Curt Furberg of Wake Forest University reviewed the new report for NPR. He says it shows short-term users of Vioxx were at greater risk of heart problems than previously described in the NEJM paper.

The data in that paper indicated "it takes about 18 months to see an increase in risk," said Furberg. "With the new information, the risk appears to be present from the beginning, and it increases gradually over time."

This point is worth billions of dollars to Merck. Thousands of patients, who suffered heart problems, are suing the company. Many took Vioxx for less than 18 months.

Merck has long said there's no evidence that Vioxx caused those problems. It says the published APPROVe data show that most of the risk of heart problems was in patients who were on the drug for much longer than 18 months.

And it says the new data from the APPROVe study do not change that.

"The new APPROVe data do not establish that the risk for Vioxx starts earlier than had previously been reported.''

Furberg says Merck's way of analyzing the study is faulty.

"It's not proper scientifically to start slicing up the experience in a three-year study, and look at it after nine months or 18 or 22. It's not the way it should be done. You look at the total experience and pass judgment on the total experience,'' he said.

If you do that, Furberg says, the results show that the risk of cardiac events on Vioxx is almost twice as high over the entire study, including in the early months.

Cardiologist Steven Nissen of the Cleveland Clinic, who also reviewed the report for NPR, agrees that it gives additional evidence that Vioxx is risky from the start.

"Why should a drug have no adverse effect for 18 months and then all of a sudden these events would begin to occur? It never made good biological sense,'' Nissen said.

Merck's new report also has detailed data on heart problems that patients had after they stopped taking Vioxx. Merck released the bare bones of those findings last week. The company said the data did not show that Vioxx patients were at greater risk of heart problems after they stopped the drug.

Both Nissen and Furberg disagreed with that interpretation last week. Now they say the detailed information Merck gave the FDA confirms their opinion that the risks from Vioxx persist even one year after patients stop taking the drug. They also say the risks are almost as large as when patients are on the drug.

Cardiologist Nissen says this understanding of Vioxx's risks has important practical consequences, for patients formerly on the drug, particularly the elderly.

As a protective measure, Nissen is advising his elderly patients who had previously taken Vioxx, to regularly take a low-dose of aspirin, which is known to reduce the risk of cardiovascular events.

He adds there's no telling when or if Vioxx patients ever lose the disadvantage of having taken the drug. He says Merck should continue to follow patients in this study to find out.
]]> Doctors say Vioxx risks lingered a year after patients stopped use http://www.yourlawyer.com/articles/read/11693 Sat, 13 May 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11693
The physicians disputed the interpretation of a study by Merck & Co., Vioxx's maker.

Company officials had contended Thursday that Vioxx users weren't at increased risk of heart attack or stroke in the year after quitting the drug.

"Merck misrepresented the results of this study," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who is leading a large international study of several painkillers and their risks.

Several other doctors agreed, although one said the risk appeared to decline somewhat during the one-year follow-up period.

Merck contends the number of patients in the affected group was so small the data were not "statistically significant," meaning that something other than Vioxx could have affected the patients' health.

But the doctors said that, depending on which way the data are calculated, patients who had taken Vioxx had a 64 percent to 85 percent higher risk of heart attack, stroke and death during the year after stopping the drug, compared with patients who were taking a placebo.

In addition, the Vioxx group on average had a 74 percent higher risk of cardiac complications throughout the three years they were on the drug and the one-year follow-up.

Merck spokesman Michael Heinley, asked about the doctors' claim that Merck's statements were misleading, said, "That would be their opinion."

During a teleconference with reporters and stock analysts late Thursday after Merck released the new data, Merck Research Laboratories President Peter S. Kim repeatedly stressed that there was no statistically significant increase in heart attack and stroke risk in the year after the study patients stopped taking Vioxx.

Merck pulled Vioxx from the market in 2004 because of data showing it doubled the risk of heart attack and stroke after 18 months' use.

The company faces about 10,000 lawsuits over the drug and has lost half of the six cases that have been tried so far.]]> Merck's Worst Nightmare, a Study that Shows Vioxx Heart Attack Risk Linked to (Very) Short-Term Use http://www.yourlawyer.com/articles/read/11640 Wed, 03 May 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11640
To a great extent, Merck has legitimized its strategy of refusing to settle any of the roughly 12,000 Vioxx personal injury and wrongful death cases on the basis of its conviction that it should ultimately prevail on all of the short-term cases (by dismissal, verdict, or on appeal) thereby eliminating about half of the cases.

Merck also believes that even many of the long-term-use Vioxx plaintiffs suffered their injuries (or deaths) as a result of one or more chronic medical condition such as cardiovascular disease, diabetes, hypertension, or obesity.

Thus, the pharmaceutical giant sees no reason to enter into a global settlement of all pending lawsuits against it as long as the company and its attorneys still perceive so many “defensible” cases exist.

Unfortunately for Merck, however, things have not turned out that way since it has already lost three lawsuits, including two short-term-use cases, and has been found liable for punitive damages, which are not covered by insurance, in each of those cases. Nonetheless, the lack of definitive proof linking short-term use of Vioxx to an increased risk of heart attack and stroke has kept Merck on the offensive and putting plaintiffs to their proof.

Now, however, that confidence has to have been shaken by the results of a Canadian study published in the Canadian Medical Association Journal. That study analyzed data on 114,000 patients and reported that 239 people in Quebec, 66 and over, suffered heart attacks while taking Vioxx between 1999 and 2002.

None of the Vioxx users had a history of heart attack. The Celebrex users did not exhibit any such statistical increase in heart attack risk.

An analysis of the data indicates that over 25% of those people had their heart attacks within two weeks of their first prescription for Vioxx. The team found that “among elderly users of predominantly low doses of these agents, short-term use of rofecoxib is not without risk, and that risk of MI [heart attack] is not restricted to continuous users nor accentuated with longer-term use."    

Thus, the researchers see the need for early monitoring of COX-2 side-effects as well as continued monitoring of patients after the discontinuance of the medication. Some 30,200 Vioxx and 45,000 Celebrex users were studied for about 2 ½ years.

Of the 239 heart attacks in Vioxx patients, 65 took place within only 9 days of starting Vioxx therapy.  
 
Plaintiffs’ attorneys see the Canadian study as a major setback for Merck’s defense strategy that will make even the shortest-use cases more viable and far less defensible. It could also prompt Merck to reconsider its position on settlement.
]]> Study Finds Vioxx Dangers Occur Earlier Than Expected http://www.yourlawyer.com/articles/read/11644 Wed, 03 May 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11644
A new study led by Queen's University researcher Linda Lévesque shows that heart attacks related to the use of Vioxx a drug once popular for the treatment of pain and inflammation can occur within the first two weeks of use.

A quarter of patients who suffered a heart attack while taking Vioxx did so within the first two weeks of their first Vioxx prescription, said Lévesque, of Queen's Department of Community Health and Epidemiology.

"This demonstrates that cardiovascular risks from taking Vioxx may occur much earlier than previously believed," she said. Conducted with McGill University researchers James Brophy and Bin Zhang, the findings appear on-line in the Canadian Medical Association Journal.

"Our previous study on COX-2 inhibitors, which included Vioxx and Celebrex, evaluated whether there was an increased risk of heart attack while taking these medications; the answer was yes for Vioxx," explained Lévesque.

In the current study, funded by the Canadian Institutes for Health Research (CIHR), the pattern of cardiovascular risk in Québec seniors was assessed over a three-year period.

The additional cardiovascular risk actually decreased with longer duration of use, suggesting that the period of highest susceptibility for most people taking Vioxx may occur earlier than previously believed. The study also documents that cardiovascular risk returns to normal within one month of stopping the drug.

Vioxx was voluntarily withdrawn from the market on September 30, 2004, after a study showed that it doubled patients' risk of heart attacks and strokes after 18 months of use.

This study is the first to specifically address the question of the timing of cardiovascular risk associated with COX-2 inhibitors.
]]> Health Canada probes Accutane side effects http://www.yourlawyer.com/articles/read/11565 Mon, 17 Apr 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11565
Twenty-nine cases of patients who developed a vascular disorder after taking isotretinoin, the generic name for Accutane, have been reported since the drug was approved in Canada in 1983.

Eleven involved strokes, blood clots or a heart attack, none of which are labelled as possible reactions in the drug's prescribing information. The patients ranged in age from 15 to 48.

One 18-year-old with no known risk factors suffered a stroke two months after starting the drug.

"Health-care professionals are encouraged to report any cases of myocardial infarction, cerebrovascular and thromboembolic disorders suspected of being associated with isotretinoin," a new Health Canada report on adverse drug reactions says.

Canadian retail pharmacies filled 224,515 prescriptions for Accutane last year, worth $33.8 million, according to IMS Health Canada. Isotretinoin's use is expected to grow as cheaper generic versions reach the market.

A spokesperson for Health Canada stressed there is no evidence Accutane caused the rare reports of stroke and blood clots in users. They're based on suspicions only and could be due to some underlying illness. Some of the patients had risk factors for stroke, such as high blood pressure or obesity.

"This information at this point is strictly observational, they are only suspected to be associated with Accutane. Causal relationships have not been determined," Health Canada spokesperson Chris Williams said.

The cases were published in the latest issue of the Canadian Adverse Reaction Newsletter "to stimulate reporting to see if something needs to be done," Williams said. "That's why we're putting it out."

It's been estimated that as few as one per cent of suspected reactions are ever reported under Canada's voluntary reporting system,]]> PATCH MAKER PAYOUT http://www.yourlawyer.com/articles/read/11531 Sun, 09 Apr 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11531
Ortho-McNeil Pharmaceutical of Raritan, N.J., a subsidiary of Johnson & Johnson, has settled a dozen lawsuits for millions of dollars in the last few months, and more than 100 other suits are pending - including one by the family of a deceased 18-year-old Manhattan student.

One lawyer who asked not to be identified said Ortho-McNeil has been "approaching everyone" representing women, and that lawyers have begun submitting cases for settlement.

The increasingly popular Ortho-Evra patch was heavily marketed at its introduction in 2002 with sexy ads, supermodels, and Norwegian beach volleyball players. It was called as safe and effective as the Pill, but more convenient because it's changed just once a week.

The first hint of danger came when Zakiya Kennedy, 18, a Fashion Institute of Technology student and aspiring model, collapsed on a subway platform in April 2004. The city medical examiner attributed her death to the Ortho patch.

The Post since uncovered dozens of women who had died or been crippled after wearing the device, which delivers estrogen to the bloodstream through the skin.

A dozen clients have settled their cases out of court.

They include Philomena Ugochukwa, a 37-year-old mother of two who suffered a blood clot that caused a massive stroke and brain damage after she'd worn the patch less than two weeks.

The former beauty-shop operator was totally paralyzed, and remains an invalid.

The 11 other plaintiffs to settle include women ages 18 to 47, from New Jersey and other states. The women suffered blood clots in the leg, lung and brain; one had a stroke.

Sources estimated Ugochukwa's award at more than $10 million.

Told yesterday about the first settlements, Zakiya Kennedy's grandmother Roberta Alloway, had a bittersweet reaction: "It's too late for my granddaughter, but her death brought all this to light and spread the warning to other young women."

"Some good has come out of it."
]]> Jury: Merck Liable for Man's Heart Attack http://www.yourlawyer.com/articles/read/11524 Wed, 05 Apr 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11524
The state jury found the company failed to adequately warn both men about the risk factors linking the now-withdrawn painkiller to heart attacks and strokes, but said the drug was only a factor in one of the men's illnesses.

Jurors ruled that only John McDarby, 77, a retired insurance agent from Park Ridge, should receive compensation.

McDarby was awarded $3 million for pain and suffering and his wife was awarded $1.5 million. He did not immediately comment after the verdict.

The trial also included the case of Thomas Cona, a 60-year-old businessman from Cherry Hill who was stricken on a golf course after what he said was nearly two years of use. The jury said he should receive $45 to compensate him for the cost of his medication. Cona declined comment after the verdict.

A Merck spokesman, Chuck Harrell, called the split verdict a "disappointment" but said "the jury has spoken."

The verdict came after less than two days of deliberations by a jury of six women and two men.

The trial was the first dealing with plaintiffs who blamed illnesses on long-term use of the painkiller.

McDarby, a diabetic who took Vioxx for four years, suffered his heart attack in his living room and broke his hip as a result, triggering a health slide that has left him using a wheelchair and unable to care for himself, according to his attorneys.

Merck shares dropped in after-hours trading Wednesday evening, falling 99 cents, or 2.8 percent. Shares rose 51 cents, or 1.4 percent, in regular trading on the New York Stock Exchange, a day after Merck had raised its forecast for first-quarter profit about 15 percent.

The jury was expected to return to court Thursday to decide whether the company will face punitive damages. The judge told jurors not to comment until after the entire trial ends.

Compensatory damages are given to cover a plaintiff's actual financial losses, such as medical treatment costs and lost income. Punitive damages penalize a defendant for bad conduct.

The verdict capped a monthlong trial in which lawyers for Cona and McDarby laid out now-familiar accusations that Merck rushed the drug to market in a losing battle against competitor Celebrex and actively ignored evidence it was causing cardiovascular complications.

The verdict is the second court loss for Merck, against two victories, one in a retrial.

Like jurors in five Vioxx-related trials before it, the jury saw dozens of e-mails, internal Merck documents and safety study reports and heard live testimony from a parade of cardiology experts, academics and Merck executives.

Plaintiffs lawyers said Cona and McDarby wouldn't have been taking the drug for their arthritis pain if Merck faced with clinical studies suggesting Vioxx was causing heart attacks and strokes had not persuaded the Food and Drug Administration to dilute a new label warning in April 2002.

Merck said it thoroughly tested the drug before introducing Vioxx in 1999. It was a huge hit with older consumers because of its efficiency as a pain reliever and its lack of gastrointestinal side effects that were typical of some arthritis pain relievers.

At its peak, it sold $2.5 billion in 2003.

But Merck ultimately pulled it from the market in September 2004 after a clinical study showed that people who took it longer than 18 months faced twice the risk of suffering heart attacks and strokes.

The company now faces about 9,650 suits in state and federal courts over Vioxx.

It was the second Vioxx trial in New Jersey, where more than 5,000 suits are pending all before state Superior Court Judge Carol Higbee, whose overloaded docket prompted her to impose time limits on the lawyers arguing the case.]]> Federal Wrongful Death Action Against Maker of Ortho Evra Birth Control Patch Filed by Parker & Waichman, LLP on Behalf of Estate of 20-Year-Old Who Died from Pulmonary Thromboembolism http://www.yourlawyer.com/articles/read/11514 Sun, 19 Mar 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11514 In the vast majority of cases where a prescription drug is the subject of personal injury or wrongful death litigation, the “victim” was already suffering from a physical or psychological illness, disease, or other health problem that may actually caused, or at least contributed to, the alleged injuries.

For example, in the thousands of cases pending against Merck & Co. for injuries or deaths allegedly caused by the COX-2 inhibitor arthritis drug, Vioxx, virtually all of the plaintiffs had pre-existing medical problems like diabetes, hypertension, elevated cholesterol, and various degrees and types of cardiovascular disease.

In the case of antidepressants claimed to have been responsible for suicides, many of the alleged victims were already suffering from significant psychological or psychiatric problems.

Thus, it is often difficult to definitively link a drug directly to an injury or death because of these intervening factors that may, or may not, have played some role in the process.

This, however, is not the situation with respect to deaths and injuries allegedly caused by the Ortho Evra birth control patch since the victims are virtually all healthy women of child-bearing age with no significant medical problems that would otherwise explain their sudden and tragic deaths. In fact, many of the victims have been between the ages of 14 and 30 and in excellent health.    

This is precisely what is alleged by the family of a 20-year-old woman who died from a pulmonary thromboembolism (blood clot) after using the Ortho Evra contraceptive patch for 10 months.

In June 2004, paramedics arrived to find the decedent in an idioventricular rhythm. She had reportedly collapsed after awakening and gasping for air.

The paramedics performed advanced cardiac life support and rushed the young woman to the hospital by ambulance where efforts to resuscitate her failed.

An autopsy revealed the immediate cause of death was pulmonary thromboembolism.

The suit was filed by the law firm of Parker & Waichman, LLP, in the United States District Court for the District of New Jersey in Newark, New Jersey. Parker & Waichman is a major New York based plaintiffs’ personal injury law firm that is heavily involved in pharmaceutical litigation.
 
In February of this year, the FDA acknowledged the finding of a new study that indicates women using the Ortho Evra birth-control patch have an elevated risk of developing blood clots.

As previously reported, notwithstanding the fact that this is far from the first evidence linking this potentially fatal side-effect to the “patch,” the FDA has taken the position that the results are only preliminary and do not require immediate action other than to advise women to discuss this risk with their doctors.

According to Dr. Daniel Shames, who is director of the division of reproductive and urological drug products at the FDA, preliminary findings from a study by i3 Drug Safety found women using the patch had twice the risk of developing blood clots compared to women taking birth-control pills.

In November 2005, after years of debate over the safety of the Ortho Evra birth-control patch, the drug’s manufacturer Ortho-McNeil (a subsidiary of Johnson & Johnson the world’s 4th largest drugmaker) finally acknowledged the fact that women who use the product are at a significantly greater risk of blood clots, stroke, and death than woman who use other forms of oral contraceptives.

Ortho-McNeil has now admitted that women who use the patch can be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill instead.

Critics of both the ‘patch’ and the FDA’s approval and monitoring practices, however, see the warning as simply another example of economics being placed above public safety. There has been a constant chorus of warnings about the extremely serious side-effects associated with the patch from a number of experts as well as the consumer watchdog group, Public Citizen (www.worstpills.org) and the Associated Press.

Several other lawsuits have already been commenced around the U.S. alleging that serious injuries and deaths have been caused by the Patch.

CBS News also presented a significant story from Austin, Texas, concerning documents produced in the course of a pending lawsuit involving a young mother who was paralyzed by a stroke only 12 days after she began using the patch. She is now a total invalid.        

According to that story, Ortho-McNeil’s own records show the company received some 500 reports of serious health problems associated with the patch between April 2002 and December 2004. During that time only 61 such reports were received with respect to all types of existing oral contraceptives.

In addition, there were four times as many strokes in women using the patch as in women using oral contraceptives even though three times as many women were taking those other forms of birth control.

Finally, the evidence indicated, that in medically confirmed cases, the risk of blood clots is 14 times as high with the patch.   

An investigative report published by the Associated Press on July 18, 2005 linked the birth control patch, which contains a combination of norelgestromin and ethinyl estradiol, to an increased risk of blood clots and deaths (compared to older contraceptives) in some young healthy women.

Ortho Evra, like the other hormonal contraceptives, has a black box warning about an increased risk of cardiovascular adverse reactions in older women who smoke. This type of warning is the strongest that the FDA can request.

The Associated Press follow-up story is even more damning, however. In that article, the AP stated:

“Documents released to attorneys as a result of that litigation show Ortho McNeil has been analyzing the FDA's death and injury reports, creating its own charts that document a higher rate of blood clots and deaths in association with the patch than with the pill.

In addition, an internal Ortho McNeil memo shows that the company refused, in 2003, to fund a study comparing its Ortho Evra patch to its Ortho-Cyclen pill because of concerns there was ‘too high a chance that study may not produce a positive result for Evra’ and there was a ‘risk that Ortho Evra may be the same or worse than Ortho-Cyclen.’”

The patch, like many oral contraceptives, contains two hormones, a progestin and an estrogen. The progestin in Ortho Evra is a new drug (2001) known as norelgestromin, and the estrogen is an existing one known as ethinyl estradiol.

Ortho Evra was approved by the Food and Drug Administration (FDA) in November 2001 and is the first contraceptive product to be approved as a skin patch. It was launched and marketed in a series of “glitzy” television ads featuring “sexy models.” (CBS 11/2/05).
In 2004, the drug accounted for more than 9.9 million prescriptions with sales topping $411 million.

Contraceptives are often referred to as second- or third-generation based on their progestin component. Since some experts classify norelgestromin as a third-generation progestin, Ortho Evra is considered third-generation contraceptive.

Public citizen first listed some third-generation oral contraceptives as “DO NOT USE” drugs in 1998 and 1999 because of an increased risk of blood clots compared to the older, second-generation birth control pills.  Thus, elevated blood levels of progestin as well as estrogen are possible with the Patch.

The Associated Press used the Freedom of Information Act (FOIA) to obtain adverse drug reaction reports for Ortho Evra from the FDA and reportedly found that of the 23 cases in which death was the outcome, doctors reviewing the cases found 17 that appeared to be blood-clot-related, including 12 from 2004.

Since the FDA estimates that it receives reports of only between 1% and 10% of the serious adverse drug reactions that actually occur, the death rate for Ortho Evra may be significantly higher.

The Associated Press also analyzed the reviews of clinical trial results done by FDA physicians and scientists prior to the drug’s approval. Those results were submitted for review by Ortho-McNeil in support of Ortho-Evra and are available on the FDA’s Web site at:

http://www.fda.gov/cder/foi/nda/2001/021-180_ORTHO.htm.

Significantly, Ortho-McNeil and the FDA medical officer reviewing Ortho Evra strongly disagreed about whether two cases of blood clots in the lungs (pulmonary embolus) in young women participating in the pre-approval clinical trials were caused by the drug. The FDA medical officer wrote:

“THE REVIEWER DOES NOT AGREE WITH THE SPONSOR’S [Ortho-McNeil] ABOVE CONCLUSIONS. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases in the group” [emphasis in the original].
The FDA medical officer also included the following statement in his comments:

The professional product labeling and information written specifically for women using Ortho-Evra “should reflect the possible increased risk of venous thromboembolism (VTE) [blood clots] associated with this new transdermal combination hormonal contraceptive containing the new molecular entity progestin norelgestromin (17d-norgestimate).”

In addition, the medical officer expressed concern that 211 out of 3,088 women (6.8%) in the pre-approval clinical trials gained 10 or more pounds in the trials and noted that the contraceptive effectiveness of Ortho-Evra was reduced in women weighing more than 198 pounds (90 kilograms).

The professional product label warns that Ortho-Evra should not be used in the following circumstances:  

  • A history of heart attack or stroke
  • Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes
  • A history of blood clots in the deep veins of your legs
  • Chest pain (angina pectoris)
  • Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina
  • Unexplained vaginal bleeding (until your doctor reaches a diagnosis)
  • Hepatitis or yellowing of the whites of your eyes or of the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives such as ORTHO EVRA, NORPLANT [levonorgestrel], or the birth control pill
  • Liver tumor (benign or cancerous)
  • Known or suspected pregnancy
  • Severe high blood pressure
  • Diabetes with complications of the kidneys, eyes, nerves, or blood vessels
  • Headaches with neurological symptoms
  • Use of oral contraceptives (birth control pills)
  • Disease of heart valves with complications
  • Need for a prolonged period of bed rest following major surgery
  • An allergic reaction to any of the components of Ortho Evra

Women who may be using Ortho Evra should contact their physician if any of the following warning signals develop:

  • Sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot in the lung)
  • Pain in the calf (indicating a possible clot in the leg)
  • Crushing chest pain or tightness in the chest (indicating a possible heart attack)
  • Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a possible stroke)
  • Sudden partial or complete loss of vision (indicating a possible clot in the eye)
  • Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast; ask your doctor or health care professional to show you how to examine your breasts)
  • Severe pain or tenderness in the stomach area (indicating a possibly ruptured liver tumor)
  • Severe problems with sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression)
  • Jaundice or a yellowing of the skin or eyeballs accompanied frequently by fever, fatigue, loss of appetite, dark colored urine, or light  colored bowel movements (indicating possible liver problems)

Since contraceptives are usually prescribed to young, healthy women they should be associated with the lowest possible risk of serious adverse drug reactions.

Blood clots in the lungs were seen in two women given Ortho Evra in clinical trials conducted before the drug was even approved (in addition to several similar cases after the drug was marketed).

There is also no evidence that the patch is a superior contraceptive compared to older second-generation birth control pills.  As stated in the September 2005 issue of Worst Pills Best Pills (published by Public Citizen); “Rarely do randomized pre-approval studies, the scientific ‘gold standard’ for proving safety or efficacy, present such strong evidence of a serious problem.”  

As a result of what it considers strong evidence of the increased risk of blood clots and death, Public Citizen states: “There is no medical reason for women to use the more dangerous Ortho Evra rather than one of the older, better understood, and equally effective oral contraceptives.”

When reading the November 2005 Ortho-McNeil’s Press Release, the first thing that becomes obvious is that the company made a concerted effort to present the information in a way that was difficult (if not impossible) for anyone but an expert to understand.

For example, the acronym AUC is used without definition thereby making the references to estrogen concentrations difficult to extrapolate. AUC, however, is a measure of how much of a drug reaches the bloodstream in a set period of time, usually 24 hours. AUC is calculated by plotting drug blood concentration at various times during a 24-hour or longer period and then measuring the area under the curve between 0 and 24 hours.

When the implications of AUC are considered with respect to the amount of estrogen that can be released in a given period of time, the result is shocking since that amount can easily exceed 50 mg which is well beyond the level already determined to be unsafe.
A previous study conducted with respect to another contraceptive product (the “vaginal ring”) documented these excessively high levels of estrogen associated with the patch almost a year ago in the journal Contraception.

In addition to the risks already discussed cigarette smoking increases the risk of serious cardiovascular side effects from hormonal contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. As a result, women who use hormonal contraceptives, including Ortho Evra, should not smoke.

Finally, litigation involving Ortho Evra has been gaining momentum in recent months and especially in light of the Associated Press investigation. The litigation focuses on the claim that Ortho-McNeil knew of the blood clot risk and even disagreed with the FDA medical officer who suspected the two incidents that occurred during the clinical trial were related to the drug.

A lawsuit was filed in July 2005 against Ortho-McNeil on behalf of a 30-year-old woman who suffered fatal blood clots thought to be linked to the Ortho Evra risk. The woman was admitted into the intensive care unit shortly before her death suffering from severe headache, visual problems, vomiting, and nausea.

The other deaths reported in connection with Ortho Evra risk factors were the result of heart attacks and strokes. One of the most recent deaths linked to Ortho Evra was suffered by a 25-year- old woman who suffered fatal headaches thought to be linked to a surge of hormone release from the birth control patch.

The youngest woman to die (as reported to that point) was an 18-year-old college student who collapsed in the New York subway. As of February ten other women ranging in age from 18 to 27 had also sued Ortho-McNeil.

In September 2005, Parker & Waichman announced it had filed suit against Ortho-McNeil on behalf of a 37-year-old woman who suffered a pulmonary embolism after using the Ortho Evra contraceptive patch for seven months. That suit was also filed U.S. District Court for the District of New Jersey.

According to the complaint in that lawsuit, from April 2002 through September 2003, the U.S. Food and Drug Administration logged 9,116 reports of adverse events because of the patch.

This is significant since there were only 1,237 adverse reports by women taking the leading oral contraceptive, Ortho Tri-Cyclen, over a six-year period even though that drug was used by almost six times as many women as Ortho Evra in 2003.
Ortho-McNeil has routinely denied the allegations that these deaths and injuries were the result of Ortho Evra risk factors. It claimed that the “unsolicited reports” it received were not reliable evidence of a problem with the drug.

The company also claimed its own investigation had not found any causal factor linking these deaths to Ortho Evra and relied on the absence of any reports of fatal adverse side-effects during the clinical trials as proof of the drug’s safety.

Ortho-McNeil’s reluctance to accept even the possibility that the patch could be at fault has lead to the drug being kept on the market without adequate warnings. Even the company’s press release and FDA advisory regarding new labeling requirements do not satisfy the patch’s many critics.

In the eyes of those critics, the fact that Ortho-McNeil notified the FDA that it has undertaken a “much larger study” with respect to the potential problem of blood clots, strokes, and death associated with the patch merely prolongs the time in which millions of women are exposed to an unacceptable risk of catastrophic injuries and death.

In addition to the rather cryptic press release issued by Ortho-McNeil in November 2005 concerning the serious risks associated with its Ortho Evra birth control patch, the FDA published its own information for consumers wishing to learn more about those potentially fatal side-effects (http://www.fda.gov/bbs/topics/news/2005/NEW01262.html) as well as a series of questions and answers. (http://www.fda.gov/cder/drug/infopage/orthoevra/qa.htm)

Some of the more telling remarks in the FDA material follow:

“FDA is announcing a revision to the label for the drug Ortho Evra. This change includes a new bolded warning about higher exposure to estrogen. Higher levels of estrogen may put some women at increased risk for getting blood clots.”

“A woman on Ortho Evra may be exposed to approximately 60% more estrogen than if she were taking a typical 35 microgram estrogen birth control pill. Estrogen use is linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks.”

“In general, woman may be at higher risk for getting side effects if she takes higher doses of estrogen. Women should discuss with their health care professional whether the Ortho Evra patch is a good method of contraception for them.”

Following the November 2005 Ortho-McNeil Press Release and FDA Advisory, there have been several reports of doctors and other healthcare providers curtailing or even suspending the prescribing of the patch.

The Wall Street Journal (WSJ)  reported that: “Many doctors have stopped writing prescriptions for a popular form of birth control after the Food and Drug Administration warned earlier this month of increased hormone exposure to women who use it.”

(http://online.wsj.com/article/0,,SB113262165542103693,00.html?mod=djemHL).

According to the WSJ:  “[A] number of individual practitioners and major health-care providers say they don't want to take any chances. In Memphis, Tenn., obstetrician and gynecologist Henry Sullivant says he has stopped writing new patch prescriptions and suggests that his roughly two dozen patch users try other forms of prescription contraceptives, such as the pill or a monthly vaginal ring. Pennsylvania State University, which provides health services for 42,000 students, is no longer issuing prescriptions and says it is considering whether to contact all students who have been given prescriptions for Ortho Evra, even if they are no longer at the university.”

In a effort to exercise caution, similar actions are being taken by many other university health officials including those at the University of Texas at Austin, Stanford University, the University of California, Berkeley, and Connecticut College in New London, Connecticut where one patch user experienced a blood clot in her lung last spring.

In addition “Lee Shulman, incoming board chairman of the Association of Reproductive Health Professionals, says he expects that ‘there will be a decrease in use’ of Ortho Evra, at least over the next several months. He adds that he has been inundated with doctor and patient phone calls asking whether the patch is safe to use.”

A number of litigation attorneys we spoke with, who are familiar with pharmaceutical litigation, agreed that it is becoming more difficult for doctors and major healthcare providers like colleges and universities to ignore the mounting evidence and warnings and simply write thousands of prescriptions for the patch. The percentages indicate that when that many prescriptions are written some of the women will suffer serious or fatal adverse reactions.

There are also many well-publicized law suits alleging deaths and catastrophic injuries from the very side-effects contained in the November 2005 warning. Thus, any doctor writing a prescription for the patch from that point on is doing so at his or her peril. Given the potentially fatal side-effects of the drug, writing a prescription now could be considered irresponsible in terms of good and accepted medical practice especially if an otherwise healthy woman is paralyzed or dies from a stroke caused by blood clots after using the patch.

Thus, it is not surprising that so many healthcare providers are rethinking their policies and recommending alternative medications to their patients.

In mid-November another high-profile wrongful death case was commenced against Ortho-McNeil and Johnson & Johnson. It involves Alycia Brown, an eighth-grader in La Crosse, Wisconsin, who died of blood clots in her lower pelvis on May 7, 2004. She had been using the Ortho Evra birth control patch for about eight weeks.

The federal law suit filed in Madison by her parents claims the patch was the cause of their daughter’s tragic death. The La Crosse County medical examiner has found that Ortho Evra was a likely contributing factor in Alycia’s death.

Although many lawsuits have already been commenced against Ortho-McNeil and its parent company, Johnson & Johnson, for injuries and deaths allegedly caused by the patch, the 14-year-old is now the youngest known victim.

As Lorie Brown, Alycia’s grieving mother, told reporters:  "I'm out to let people know: get off (Ortho Evra). That's my biggest goal here. I didn't save her life, but maybe I can save somebody else's." It seems that many responsible doctors and major healthcare providers are trying to do the very thing.

Many experts, consumer watchdog groups, and critics of the FDA drug approval process in general, and Ortho Evra in particular, believe the dangers presented by the patch should have been obvious to the FDA before the drugs approval. They are also concerned by the FDA’s position that it intends to do nothing at present because it considers the information regarding the risks posed by Ortho Evra merely “preliminary.”

(Sources: HoustonChronicle.com, Public Citizen – Worst Pills Best Pills; CBS News; Associated Press; Food and Drug Administration Web Site; Wall Street Journal; Newsinferno.com Archives)

]]> FDA Issues Warning to Manufacturers and Distributors of Unapproved Drugs Containing Steroids http://www.yourlawyer.com/articles/read/11467 Fri, 10 Mar 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11467 The Food and Drug Administration (FDA) has again issued a stern warning to several makers and distributors of unapproved drugs containing steroids that continuing to distribute and sell these products without the approval of the FDA could result in regulatory action including seizure of the offending products and an injunction prohibiting their sale.


The FDA warns that these products, which are marketed as dietary supplements and promoted for building muscle and increasing strength, may lead to serious long-term adverse health affects in men, women, and children.


These products claim to be anabolic. Anabolic steroids are linked to many adverse health consequences, such as liver toxicity, testicular atrophy and male infertility, masculinization of women, breast enlargement in males, short stature in children, adverse effects on blood lipid levels, and an increased risk of heart attack and stroke.


“FDA takes its responsibility to protect Americans from dangerous unapproved drugs seriously. Today’s action is indicative of our resolve,” said Margaret O’K. Glavin, FDA’s Associate Commissioner for Regulatory Affairs.


Consumers who have any of the products listed below should stop taking them immediately and return them to their place of purchase. The FDA issued warning letters for the following so-called dietary supplement products:


Anabolic Xtreme Superdrol, manufactured for Anabolic Resources LLC, Gilbert, Arizona, and distributed by Supplements To Go, Cincinnati, Ohio; and Methyl-1-P, manufactured for Legal Gear, Brighton, Michigan, and distributed by Affordable Supplements, Wichita, Kansas.
Copies of the warning letters can be accessed at the following links:


Affordable Supplements
http://www.fda.gov/foi/warning_letters/g5739d.pdf
http://www.fda.gov/foi/warning_letters/g5739d.htm


Anabolic Resources LLC
http://www.fda.gov/foi/warning_letters/g5736d.pdf
http://www.fda.gov/foi/warning_letters/g5736d.htm


Legal Gear
http://www.fda.gov/foi/warning_letters/g5738d.pdf
http://www.fda.gov/foi/warning_letters/g5738d.htm


Supplementstogo.com, LLC
http://www.fda.gov/foi/warning_letters/g5737d.pdf
http://www.fda.gov/foi/warning_letters/g5737d.htm

]]> ADD Drug Strattera, Already Under FDA Scrutiny, Raising New Safety Concerns in UK as Well http://www.yourlawyer.com/articles/read/11374 Tue, 21 Feb 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11374
On September 28, 2005 for example, Lilly declared it was adding a black-box warning to Strattera. That warning advises that the drug may increase suicidal thoughts among youths. 

FDA officials said Eli Lilly must also create a medication guide for patients and healthcare providers pertaining to the new black box warning. Black box warnings are the most prominent and serious of medication warnings.

The FDA said Lilly submitted results from a Strattera clinical trial of 1,357 youths taking the medication that found five of them had increased suicidal thoughts, while none of 851 youths taking a placebo showed such changes. Lilly said one youth attempted suicide during its Strattera trials, but that researchers saw no signs of increased suicidal thoughts among adults.

Strattera has also been linked to liver problems. In 2004, Lilly warned doctors to stop prescribing Strattera in patients with jaundice or who show signs of liver damage.

Lilly warned that Strattera can cause severe drug related liver injury that can progress to acute liver failure resulting in death or the need for a liver transplant. In December 2004 the FDA updated Strattera's label to include the serious liver side effects.

In December of last year, Dr. Thomas Laughren, director of the FDA's division of psychiatry products, said the federal government requested Lilly to assess 13 clinical trials conducted on children to measure a suicide risk.

"The risk for any individual patient taking this drug is quite low, but from a public health standpoint, four (case) per thousand is a fairly big signal, given there are tens of thousands of patients taking this drug," Laughren said.

In June 2005, the FDA announced it will be investigating all attention deficit hyperactivity disorder drugs including Strattera, Ritalin, Concerta, and Adderall in response to reports of serious psychiatric side effects in patients taking Concerta and Ritalin. Some ADHD drugs are also associated with cardiovascular side effects.

In what many experts are viewing as an unusual turn of events, an FDA advisory panel, in January of this year, voted (8-7-1) to recommend that the agency order the inclusion of the most serious “black box” warning on all stimulant ADHD medications due to evidence of a potential risk of heart attacks, strokes, and sudden death. The drugs include amphetamines, such as Adderall, and methylphenidates, sold as Ritalin, Concerta, Methylin, and Metadate.

The panel also voted 15-0-1 to recommend that the FDA require that the drugs include a medication guide for patients and parents.
This new controversy was prompted by data that showed that widely prescribed ADHD drugs like Ritalin may be lined to as many as 25 deaths that occurred between 1999 and 2003. Of these deaths, 19 involved children.

In addition, the FDA was advised of 54 cases involving serious cardiovascular problems like heart attacks, strokes, hypertension, heart palpitations and arrhythmias in both adults and children taking these medications.

There is also the open issue of another 26 deaths between 1969 and 2003 in medicated ADHD patients involving suicide, intentional overdose, drowning, heat stroke, and underlying diseases.

The panel’s vote also caught the FDA off guard because the committee was convened to advise the agency on how to design studies to assess possible risks associated with stimulant ADHD medications. (Adderall is the only non-stimulant ADD drug).

During the meeting, however, talk soon turned to the over-prescribing of these drugs and the public as well as many doctors were unaware of these serious potential risks. The panel then agreed to consider the enhanced-warning issue that was outside of its planned agenda.
The FDA has attempted to back off from the unexpected action by the panel by issuing a statement that it would be reluctant to require a black box warning based on a “theoretical risk.”

Such warnings could unreasonably deter patients and doctors from using a drug that could benefit them, said Robert Temple, MD, director of medical policy at the FDA's Center for Drug Evaluation and Research. He stated: "The absence of bona fide problems in your hand pushes against the box. We will also, frankly, worry about the possibility that overstatement can do active harm."

Thus, Temple indicated the full FDA would wait for the recommendation of a pediatric advisory committee scheduled for March before reaching any decision with respect to new warnings. That panel, which is made up of pediatricians and psychiatrists, is considered more likely to look favorably on the benefits of ADHD drug treatment as outweighing the potential risks. 

Now comes word that Strattera is faring no better in the UK in light of these safety concerns well as the possibility that the drug is also associated with seizures and a potentially dangerous lengthening of the interval between heartbeats.

According to IndyStar.com, the Tacoma (Washington) News Tribune, and Reuters, the “warnings are based on an internal report by the British Medicine and Healthcare Products Regulatory Agency. The report, which has not been made readily available to the public, was obtained by The News Tribune after a Swedish court ordered it released in that country.

“Though the number of seizures and heart-rhythm problems is small, the British agency said problems could be under-reported, and it warned doctors and consumers that the drug should be used with caution in people prone to such problems.

“In particular, they warned about potential heart problems when Strattera is combined with antidepressants like Paxil and Prozac.”
Although British authorities still believe the drug’s benefits outweigh its risks, they are updating the drug's label in that country to warn of the possible problems. Presently, no warnings regarding the seizure risk are contained in the U.S. labeling. The heart problem risk, however, was inserted in the 25-page U.S. label in January at the request of the FDA.]]> Vioxx Cox-II Inhibitors Adderall ADHD Drugs Stroke Side Effects Injury Attorney http://www.yourlawyer.com/topics/overview/stroke Tue, 21 Feb 2006 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/stroke Stroke
A stroke or (brain attack) takes place when a blood clot blocks a blood vessel or artery. Additionally a stroke can happen when a blood vessel breaks, disrupting blood flow to an area of the brain. When a brain attack occurs, brain cells are destroyed immediately in the area. These cells usually die within minutes to a few hours after a stroke starts. Strokes are the nation's third leading cause of death, behind Heart Disease and Cancer. Approximately 700,000 Americans each year suffer a new or recurrent stroke.

A stroke takes place nearly every 45 seconds. Strokes kill an estimated 163,000 people a year. Just about every 3 minutes someone dies from a stroke. Of every 5 deaths from a stroke, 3 occur in women and 2 in men. The 2002 stroke death rates per 100,000 populations for specific groups were 54 for white males, 53 for white females, 82 for African American males and 72 for African American females.

Ischemic strokes account for close to 83% of all cases. Ischemic strokes form as a result of an obstruction within a blood vessel supplying blood to the brain. The main condition for this type of obstruction is the development of fatty deposits lining the vessel walls. This condition is called atherosclerosis. These fatty deposits can cause two types of obstruction: cerebral thrombosis and cerebral embolism.

Cerebral thrombosis refers to a thrombus (blood clot) that develops at the clogged part of the vessel. Cerebral embolism refers to a blood clot that forms at another location in the circulatory system, usually the heart and large arteries of the neck and upper chest. Another major cause of embolism is an irregular heartbeat, known as atrial fibrillation. Conditions where clots can form in the heart, dislodge and travel to the brain are created.

Hemorrhagic strokes represent about 17% of stroke cases. Hemorrhagic strokes result from a weakened vessel that ruptures and bleeds into the surrounding brain. The blood accumulates and compresses the surrounding brain tissue. There are two types of hemorrhagic strokes: intracerebral hemorrhage and subarachnoid hemorrhage.

Hemorrhagic stroke occurs when a weakened blood vessel ruptures. Two types of weakened blood vessels usually cause hemorrhagic stroke: aneurysms and arteriovenous malformations (AVMs). An aneurysm is a ballooning of a weakened region of a blood vessel.  If left untreated, the aneurysm continues to weaken until it ruptures and bleeds into the brain.

An arteriovenous malformation (AVM) is a cluster of abnormally formed blood vessels. Any one of these vessels can rupture, also causing bleeding into the brain.  Transient ischemic attacks - Also called TIAs, transient ischemic attacks are minor or warning strokes. In a TIA, conditions indicative of an ischemic stroke are present and the typical stroke warning signs develop. However, the obstruction (blood clot) occurs for a short time and tends to resolve itself through normal mechanisms.

Symptoms of Strokes include: confusion, trouble speaking or understanding, trouble seeing in one or both eyes, numbness or weakness of face, arm or leg, especially on one side of the body, trouble walking, dizziness, loss of balance or coordination, severe headache with no known cause, vomiting, nausea, fever, fainting, coma and convulsions.

Another major contributing factor causing strokes in the use of prescription medcines. The below is a list of the drugs associated with stroke:
  • Attention Deficit Hyperactivity Disorder drugs: Adderall, Concerta, Cylert, Ritalin and Strattera
  • COX-II Inhibitors: Bextra, Celebrex and Vioxx
  • Hormone Replacement Therapy (HRT) drugs: Premarin, Premphase and Prempro
  • Atypical Antipsychotic drugs: Abilify, Clozaril, Geodon, Risperdal, Seroquel and Zyprexa

If you or a loved one has taken Atypical Antipsychotics, ADHD drugs, HRT drugs or COX-II Inhibitors and suffered a stroke, please fill out the form at the right for a free case evaluation by a qualified defective drug attorney.

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