Yourlawyer.com (Cylert News) http://www.yourlawyer.com/topics/overview/cylert Sat, 21 Nov 2009 03:44:07 -0800 pixel-app en 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.]]> 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.]]> ADHD drug makers to warn of side effects http://www.yourlawyer.com/articles/read/12580 Wed, 21 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12580
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.]]> 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 to probe ADHD drug safety http://www.yourlawyer.com/articles/read/11147 Thu, 05 Jan 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11147
The move follows reports of sudden deaths, strokes, heart attacks and high blood pressure in both children and adults taking drugs to treat ADHD, according to the agency.

Last June, the FDA announced an investigation into the safety of ADHD products based on the stimulant drug methylphenidate, including Johnson & Johnson's once-daily Concerta product, and said it was considering extending the review to include all ADHD treatments on the market. But the agency was subsequently advised to hold back on any label changes until it was established whether the reported side effects were common to all drugs in the class.

"The few controlled clinical studies of longer term drug treatment of ADHD provided little information on cardiovascular risks," said the FDA. The Drug Safety and Risk Management Advisory Committee will be asked to discuss approaches that could be used to study whether these products increase the risk of adverse cardiovascular outcomes.

Use of ADHD drugs is expanding rapidly in the USA, according to a report published last year by pharmacy benefits company Medco. Prescribing swelled 23% among young adults (aged 20-34), with a 40% in the amount spent on these prescriptions, while use older adults also climbed, up 33% in adults aged 39-49 and 36% in those aged 50-64.
]]> FDA to examine new ways to study ADD drugs http://www.yourlawyer.com/articles/read/11148 Wed, 04 Jan 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11148
Sales of drugs to treat ADHD have increased sharply in recent years, with use growing at a faster rate among adults than children, according to a recent study by Medco Health Solutions, a prescription benefit manager. Spending on ADHD drugs soared from $759 million in 2000 to $3.1 billion in 2004, according to IMS Health, a pharmaceutical information and consulting firm.

The Food and Drug Administration said it had received reports of what it called “serious adverse events” including deaths in association with the therapeutic use of the drugs. The agency considers the reports “rare though serious,” FDA spokeswoman Susan Bro said Wednesday.

The FDA’s Canadian counterpart, Health Canada, yanked the ADHD drug Adderall XR from the market for six months last year in response to reports of 20 sudden deaths and 12 strokes in adults and children using the drug. A number of the cases involved children with structural heart defects.

The panel eventually concluded there was inadequate evidence of increased harm from Adderall XR compared with other available therapies a conclusion the FDA also reached based on data on hand.

Now the U.S. regulatory agency is asking its Drug Safety and Risk Management advisory committee to examine ways of studying further the potential cardiovascular risks of the drugs. The few studies that have looked at longer-term use of ADHD drugs provide little information on those risks, the FDA said.

“It almost sounds like cox-2 inhibitor redux,” said committee chairman Dr. Peter Gross, referring to cox-2 painkillers like Vioxx and Bextra pulled from the market because of evidence they can raise the risk of a heart attack or stroke.

The committee is to meet Feb. 9 and 10 in Gaithersburg, Md.

“The issue of drug treatment of attention deficit disorder in children has been a controversial one without this issue of cardiovascular risk too. It adds another concern to what will certainly be an interesting conversation,” said Arthur Levin, the FDA committee’s consumer representative.

A posting to the FDA Web site did not identify any of the drugs by name. However, the most commonly used ADHD drugs include Adderall XR, made by Shire Pharmaceuticals, and Ritalin, made by Novartis Pharmaceuticals Corp. Various other companies make generic versions of Ritalin as well.

Shire spokesman Matthew Cabrey said the company hadn’t been told of the meeting but added it may send representatives. Novartis did not immediately return a call seeking comment.

The committee’s Feb. 10 meeting will include updates on FDA actions on cox-2 drugs as well as a recently begun patient, doctor and pharmacist registry program for the anti-acne drug Accutane and its generic competitors.

Separately, the committee also will discuss the FDA’s Drug Safety Oversight Board, an internal, government employee-only panel created nearly a year ago.

The board is supposed to monitor FDA-approved medicines once they’re on the market and update physicians and patients with emerging information on risks and benefits.

Gross said he had concerns about the board’s impartiality and independence, as well as its relationship to his committee and the very similar work it does.]]> ADHD Drug Discontinued http://www.yourlawyer.com/articles/read/9511 Sat, 26 Mar 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/9511
The consumer group Public Citizen petitioned the Food and Drug Administration on Thursday, asking the agency to ban pemoline, also sold under the trade name Cylert, because of reported cases of liver damage in users.

Abbott Laboratories Inc., the manufacturer of Cylert, said it was already planning to discontinue the drug because of declining sales.

Pemoline was approved in 1975. Since then other drugs, including generics, have become available to treat the condition. Cylert sales were less than $1 million last year.

In its petition, Public Citizen said the drug had been withdrawn in the United Kingdom and Canada and carried two separate label warnings in this country.

Between the 1975 approval and 1996, there were 193 adverse drug reactions involving the liver ascribed to pemoline, including 13 cases of acute liver failure, Public Citizen said.]]> Cylert Liver Failure Lawyers http://www.yourlawyer.com/topics/overview/cylert Sat, 26 Mar 2005 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/cylert DOWNLOAD OUR CYLERT INFORMATION PACKAGE

Injured by Cylert?

On April 24, 2005, Abbott Laboratories Inc. halted sales and removed Cylert, an attention deficit drug from the market after a consumer group complained Cylert was too dangerous. Consumer group Public Citizen charges that Cylert has caused 21 cases of liver failure, including 13 that were fatal or required transplants.

Cylert is a stimulant that was approved to treat attention deficit hyperactivity disorder, or ADHD, in 1975. In 2004 about 117,000 prescriptions for the drug were filled in the United States, according to Public Citizen.

Reports given to the FDA show that at least 193 patients have suffered serious consequences from the drug, said Dr. Peter Lurie, deputy director of the group, Public Citizen. "This is an outmoded drug," he said, "and there is no reason for it to be still on the market. Generic companies sell copycat versions of the drug under the name Pemoline.

Public Citizen asked the U.S. Food and Drug Administration to ban Cylert and its generic competitors immediately. Generic companies can still sell their versions even after Abbott pulls the medicine, unless the FDA determines the drug was withdrawn for safety reasons. Britain and Canada removed the drug from the market, but the F.D.A. instead twice chose to stiffen warnings on the drug's label, the petition said. In 1996, the agency sent a letter to Abbott saying that the drug's marketing could continue "if and only if a good faith effort is made on your part to collect the data necessary" to measure the drug's risks.

The agency suggested that Abbott create a patient registry for this task, the letter stated. But Abbott never created a registry, the petition stated. An F.D.A. analysis concluded that Cylert increased the risk of liver failure almost 17 times, the petition stated. A 2002 agency report found that stiffer label warnings had failed to prompt doctors to increase testing of patients' livers, the petition stated.

Dr. Lurie said Public Citizen had wanted for some time to file a petition about Cylert but was only recently able to complete the task.

If you or a loved one took Cylert and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.]]>