Yourlawyer.com (Kidney Failure News)

Heart surgery drug linked to death risk

Wed, 07 Feb 2007 00:00:00 -0800

A drug widely used to prevent excessive bleeding during heart surgery appears to raise the risk of dying in the five years afterward by nearly 50 percent, an international study found.

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

Wed, 07 Feb 2007 00:00:00 -0800

Patients who are given a widely used drug to prevent excessive bleeding during heart surgery are at increased risk of dying within five years following their operations, medical researchers have found in the largest study of its kind.

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.

3 more residents of city suspected to have E. coli

Tue, 12 Dec 2006 00:00:00 -0800

Three more city residents have come down with suspected cases of E. coli infection after eating at Taco Bell restaurants, the city Health Department said yesterday, bringing the total to 12 suspected cases and one confirmed case that of a Staten Island woman.

The Islander who got sick reported eating at an unidentified Taco Bell before going to a hospital on Nov. 24. She was treated and released, and has made a full recovery, the department said.

The restaurant where she ate has been sanitized and all produce removed, health officials said.

The department previously reported inspecting a Taco Bell restaurant on Staten Island, although it did not disclose which one. It's unclear whether that is the restaurant in which the woman ate.

Health officials said the Island restaurant did not have any major food safety violations, nor did it have on the premises any green scallions, a vegetable that has been linked to the outbreak.

As of yesterday, neither of Staten Island's two hospitals reported having treated any confirmed or suspected cases of E. coli infection.

The current E. coli outbreak, which has been associated with Taco Bell restaurants in five states, has affected 64 people, including 22 in New York and 28 in New Jersey, according to a report updated yesterday by the federal Centers for Disease Control and Prevention.

E. coli is a bacteria that causes diarrhea that is often bloody and accompanied by intense abdominal cramps. It can lead to kidney failure.

It typically takes two to eight days for people to develop symptoms after being exposed to the bacteria.

Eating undercooked or contaminated beef is the most common cause of E. coli-induced illness, but people have also gotten sick from eating fresh vegetables, such as the bagged spinach that earlier this year caused a nationwide outbreak.

While fruits and vegetables should all be washed before consumption, washing does not always remove E. coli bacteria. Only cooking food thoroughly will remove the bacteria's threat.

Illnesses at Iowa Taco Joint Tied to E. Coli Outbreak

Tue, 12 Dec 2006 00:00:00 -0800

Nearly three dozen people fell ill, including 14 who were hospitalized, with symptoms consistent with infection by the E. coli bacteria after eating at a Taco John's restaurant, a local health department said. Test results were expected Monday.

The Taco John's restaurant has removed any suspected ingredients from its menu and sanitized the facility, said Tom O'Rourke, the Black Hawk County Health Department director.

Brian Dixon, vice president of marketing for Taco John's, said the company had sent a representative to review cooking and food storage procedures, and to examine cleaning reports and employee health records.

Taco John's is based in Cheyenne, Wyo. It has no connection to Taco Bell, which has been linked to an outbreak of a harsh strain of E. coli that has sickened more than 60 people in the Northeast.

The Centers for Disease Control and Prevention has confirmed 61 cases in five states, most in New Jersey, New York, Pennsylvania and Delaware, plus one in South Carolina.

On Sunday, the New York Health Department confirmed that city's first case caused by the same strain of E. coli found in the other confirmed cases, spokesman Jeff Cowley said. That person was admitted to a hospital on Nov. 24 after eating at a Taco Bell, but has fully recovered, Cowley said.

Taco Bell officials said Saturday they had determined that scallions were the likely source of the bacteria. The company said it has switched produce suppliers.

E. coli, or Escherichia coli, is a common and ordinarily harmless bacteria, but certain strains can cause abdominal cramps, fever, bloody diarrhea, kidney failure, blindness, paralysis, even death.

E. coli probe focuses on green onions

Thu, 07 Dec 2006 00:00:00 -0800

Non-meat ingredients of Taco Bell menu items are under close scrutiny by state and federal investigators trying to pinpoint the cause of an E. coli outbreak that has sickened nearly four dozen people in three states.

Taco Bell ordered scallions removed from its 5,800 U.S. restaurants Wednesday after tests by an independent lab found three samples of green onions appeared to have a dangerous strain of the bacterium.

"In an abundance of caution, we've decided to pull all green onions from our restaurants until we know conclusively whether they are the cause of the E. coli outbreak," said Greg Creed, president of Irvine, Calif.-based Taco Bell.

Later Wednesday, the U.S. Food and Drug Administration said it is gathering samples of all non-meat items served in the restaurants that could carry the pathogen and planned to test them at FDA laboratories. The items include cilantro, cheddar cheese, blended cheese, green onions, yellow onions, tomatoes and lettuce, the FDA said.

California is the nation's largest supplier of green onions. But by December, as winter sets in, the vegetable is typically imported from Mexico.

Tainted green onions from Mexico were blamed for a 2003 outbreak of hepatitis A in western Pennsylvania that was also traced to a Mexican restaurant. Four people died and more than 600 people were sickened after eating the green onions at a Chi-Chi's.

At least 46 confirmed cases of E. coli sickness linked to Taco Bell have been reported in New Jersey, New York and Pennsylvania. The FDA said late Wednesday that there are also possible cases in Delaware and Connecticut.

All 15 Taco Bell restaurants in Philadelphia voluntarily closed Wednesday following a recommendation by the city's Department of Public Health.

Two restaurants on New York's Long Island were also closed Wednesday for cleaning. The chain, a subsidiary of Yum Brands Inc., had reopened other restaurants there linked to the outbreak. A Taco Bell in South Plainfield, N.J., also remained closed for cleanup.

Investigators were focusing on a southern New Jersey warehouse that distributes food to the region's Taco Bells and a nearby produce processing plant that supplies Taco Bell restaurants in the New York, New Jersey and Philadelphia areas with green onions, shredded lettuce, regular onions, tomatoes and cilantro.

A spokesman for the processing company, Ready Pac, said Wednesday that it had cleared the plant of all raw and processed green onions, which it gets from a California grower.

"Even though the test results are not confirmed, we have taken every prudent precaution and immediately stopped production and shipments of all green onions," said Steve Dickstein, VP marketing for Ready Pac.

The company has not taken similar measures with the other vegetables, he said.

At least five people in the three states remained hospitalized, including an 11-year-old boy in stable condition with kidney damage. New Jersey's health commissioner has said the most recent case of E. coli was reported Nov. 29, so the danger of infection appears to have passed.

E. coli is found in the feces of humans and livestock. Most E. coli infections are associated with undercooked meat. The bacteria also can be found on sprouts or leafy vegetables such as spinach. The germs can be spread by people if they do not thoroughly wash their hands after using the bathroom.

E. coli, or Escherichia coli, is a common and ordinarily harmless bacteria, but certain strains can cause abdominal cramps, fever, bloody diarrhea, kidney failure, blindness, paralysis and death.

Earlier this year, three people died and more than 200 fell ill in an E. coli outbreak that was traced to packaged, fresh spinach grown in California.

FDA Statement Regarding New Trasylol Data

Fri, 29 Sep 2006 00:00:00 -0700

Since January, 2006, the Food and Drug Administration (FDA) has been conducting a safety review of Trasylol (aprotinin injection). The review was triggered by the results of two published research studies: one that reported an increase in the chance of kidney failure, heart attack and stroke in patients treated with Trasylol compared to those treated with other similar drugs, and the other that reported an increase in kidney dysfunction compared to another drug. On September 21, 2006, FDA held a public meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the safety and overall risk-benefit profile for Trasylol. At that meeting, the committee discussed the findings from the two published observational studies, the Bayer worldwide safety review, and the FDA review of its own post-marketing database.

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.

Bowel Cleansers Get FDA Warning

Fri, 05 May 2006 00:00:00 -0700

Federal health officials warned Friday of kidney failure associated with certain products used to cleanse the bowel before colonoscopies and other procedures.

The Food and Drug Administration said in an alert to doctors and patients that it has documented 22 cases of acute phosphate nephropathy, a rare but serious form of kidney failure associated with the use of oral sodium phosphates. The products cleanse the bowel by causing patients to loose large amounts of fluid through bowel movements.

Of the cases, 21 involved patients given solutions such as Fleet Phospho-soda or Fleet Accu-Prep. One patient had taken Visicol tablets. None had taken OsmoPrep tablets, a recently approved oral sodium phosphate product, the FDA said.

Colonoscopy preparation may have risks

Mon, 20 Mar 2006 00:00:00 -0800

Of all the yucky aspects of getting a colonoscopy, an exam that screens for cancer of the colon and other abnormalities the yuckiest is the preparation that takes place beforehand: emptying the bowel by ingesting purgatives.

Now some bowel-cleansing products used prior to colonoscopies have been linked to chronic kidney failure, according to Public Citizen, the consumer advocacy organization. It cited recent research published in the Journal of the American Society of Nephrology showing purgatives containing sodium phosphate are an under-recognized cause of chronic kidney failure in the United States.

Common bowel-cleansing drugs that include sodium phosphate are Visicol, a prescription oral tablet, and the non-prescription product Fleet Phospho-soda. Researchers cite several potential factors that may contribute to the development of kidney problems from sodium phosphate solutions, including inadequate hydration, a history of high blood pressure and the use of nonsteroidal anti-inflammatory drugs.

Researchers from the Columbia College of Physicians and Surgeons in New York reviewed 7,349 kidney biopsies in their facility between January 2000 and December 2004 and found 31 patients who had kidney damage that was consistent with phosphate toxicity.

Two-thirds of them had taken oral phosphate solutions prior to having colonoscopies.

Worst Pills, Best Pills is a monthly newsletter available in print and electronic formats through Public Citizen's Web site, www. WorstPills.org. It bills itself as an "expert, indepedent source for prescription drug information."

Public Citizen warned consumers about the dangers of Vioxx, ephedra, Baycol and Propulsid years before the drugs were pulled from the market.

Bowel-cleansing products, kidney failure are linked

Wed, 15 Mar 2006 00:00:00 -0800

Certain bowel-cleansing products used prior to colonoscopies are linked to chronic kidney failure, according to Public Citizen, the consumer advocacy organization.

It cited recent research published in the Journal of the American Society of Nephrology showing bowel-cleansing products containing sodium phosphate are an under-recognized cause of chronic kidney failure in the U.S.

Common bowel-cleansing drugs that include sodium phosphate are Visicol, a prescription oral tablet, and the non-prescription product Fleet Phospho-soda.

Researchers cite several potential factors that may contribute to the development of kidney problems from sodium phosphate bowel-cleansing agents, including inadequate hydration, history of high blood pressure and the use of nonsteroidal anti-inflammatory drugs.

Researchers from the Columbia College of Physicians and Surgeons in New York reviewed all of the kidney biopsies that they received between January 2000 and December 2004 and found 31 patients who had kidney damage that was consistent with phosphate toxicity, 20 of whom took oral phosphate solutions prior to having colonoscopies.

Bowel-Cleansing Products Linked to Chronic Kidney Failure

Wed, 08 Mar 2006 00:00:00 -0800

Some bowel-cleansing products that are used prior to colonoscopies are linked to chronic kidney failure, says the consumer advocacy group Public Citizen.

In a new posting on its WorstPills.org Web site, the Washington, D.C.-based group cites a recent study in the Journal of the American Society of Nephrology that shows bowel-cleansing products that contain sodium phosphate are an under-recognized cause of chronic kidney failure.

The research listed several factors that may contribute to the development of kidney problems as the result of using bowel cleansing products that contain sodium-phosphate. These include: inadequate hydration; a history of high blood pressure; and the use of nonsteroidal anti-inflammatory drugs such as ibuprofen and Celebrex.

For the study, researchers at the Columbia College of Physicians and Surgeons reviewed all the kidney biopsies received at the facility between January 2000 and December 2004. They identified 31 patients with kidney damage consistent with phosphate toxicity. Of those 31 patients, 20 had taken oral phosphate solutions before a colonoscopy.

Common bowel-cleansing drugs that contain sodium phosphate include the prescription oral tablet Visicol and the non-prescription product Fleet Phospho-soda, Public Citizen said.

FDA Urges Limited Use of Trasylol Pending Review of Data Showing Increased Risks of Heart Attack, Stroke, and Kidney Failure

Thu, 09 Feb 2006 00:00:00 -0800

The Food and Drug Administration (FDA) has issued an advisory to doctors urging them to limit the use of Bayer AG’s heart-surgery medication, Trasylol, pending an agency review of research that shows the drug causes increased risks serious medical problems including stroke, heart attack, and kidney failure.

Trasylol is widely used to prevent blood loss in patients during artery bypass graft surgery (CABG).

In a statement from the FDA, Dr. Steven Galson, Director of the agency’s Center for Drug Evaluation and Research, said: "We're working to evaluate the potential risks and determine whether there is a need for further action. In the meantime, we advise providers to carefully assess the benefits and risks of the drug for their patients."

While this evaluation is conducted by the FDA, doctors are being urged to limit the use of Trasylol to those cases where the benefit of reducing blood loss during surgery outweighed the potential risks that are now being studied.

The FDA plans to hold an advisory committee meeting later this year to reassess the risk-benefit analysis in light of existing data and to determine whether additional safety measures are required.

Only last month, a report in the New England Journal of Medicine claimed that Trasylol doubled the risk of stroke and kidney failure and increased the chance of heart attack or heart failure by 55%. Bayer said the results were "not consistent with the more than 15 years of clinical data and experience Bayer has amassed on this drug."

Bayer intends to cooperate with the FDA and other regulators while it too analyzes the data. The company also plans to issue an information letter in the next few days to heart surgeons, anesthetists and hospital pharmacists about the drug.

FDA Issues Public Health Advisory for Trasylol

Wed, 08 Feb 2006 00:00:00 -0800

The Food and Drug Administration today issued a Public Health Advisory alerting doctors who perform heart bypass surgery, and their patients, that Trasyolol (aprotinin injection), a drug used to prevent blood loss during surgery, has been linked in two scientific publications to higher risks of serious side effects including kidney problems, heart attacks and strokes in patients who undergo artery bypass graft surgery.

"FDA is conducting a thorough evaluation of the safety profile for this drug in light of the recent publications," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "We're working to evaluate the potential risks and determine whether there is a need for further action. In the meantime, we advise providers to carefully assess the benefits and risks of the drug for their patients."

FDA advises health care providers to be aware of the following:

·    Physicians who use Trasylol should carefully monitor patients for the occurrence of toxicity, particularly to the kidneys, heart or central nervous system and promptly report adverse event information to Bayer, the drug manufacturer, or through the FDA Medwatch program.
·    Physicians should consider limiting Trasylol use to those situations in which the clinical benefit of reduced blood loss is essential to medical management of the patient and outweighs the potential risks.
·    FDA is working with the manufacturer to examine the safety and benefits of Trasylol in light of the recent data and the evolving practice of medicine.
·    Patients should discuss all major risks for heart bypass surgery with their healthcare providers. These include the risks for bleeding and the available ways to lessen the risk for bleeding.

Trasylol (aprotinin injection) is the only product approved by FDA for the prevention of peri-operative blood loss and the need for blood transfusion among patients undergoing coronary artery bypass graft surgery. The drug aids the body's ability to stop bleeding and is used to lessen the bleeding risk during this surgical procedure. This surgery is done to bypass clogged arteries.
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FDA is evaluating the studies more closely, along with other scientific literature and reports submitted to the FDA through the MedWatch program, to determine if labeling changes or other actions are warranted. One study, published in the New England Journal of Medicine, reported that patients who received Trasylol had higher rates of serious kidney problems, heart attacks, and stroke compared to treatment with other drugs to prevent bleeding or to no treatment; the second study, reported in Transfusion, reported more cases of decreased kidney function in patients treated with Trasylol compared to another treatment to prevent bleeding. A limitation of both studies was that doctors chose which patients were to receive Trasylol or another treatment. It is possible that patients treated with Trasylol may have been sicker than other patients. The studies used complex statistical methods to adjust for possible differences in patient risk factors.

The agency also anticipates convening an advisory committee meeting in 2006 to discuss the existing data about the risks and benefits of Trasylol, and if additional safety measures need to be taken. The FDA will notify health care providers and patients in a timely manner following further scientific investigation of adverse event reports.

FDA also urges health care providers and patients to report adverse event information to FDA via the MedWatch program by phone (1800-FDA-1088), by fax (1-800-FDA-1078) or internet.

The Public Health Advisory is available on line at http://www.fda.gov/cder/drug/advisory/aprotinin.htm.

For more information please visit http://www.fda.gov/cder/drug/infopage/aprotinin/default.htm

Parker & Waichman, LLP Evaluating Trasylol Claims After Study Links Medication to Kidney Failure, Stroke and Heart Attack -- BAY

Tue, 31 Jan 2006 00:00:00 -0800

Parker & Waichman, LLP (www.yourlawyer.com) announces that, in addition to numerous inquiries from potential clients, it has been retained in a case involving the use of Trasylol and is actively evaluating claims concerning Trasylol, a drug commonly used during heart surgery to reduce blood loss. Trasylol, known generically as Aprotinin, is manufactured by Bayer AG (NYSE:BAY) and is estimated to have generated $600 million in sales in 2005.

A study reported last week in the New England Journal of Medicine shows that Trasylol is linked to serious side effects. The study of 4,374 patients demonstrated that Trasylol at least doubles the risk of kidney failure and stroke, or encephalopathy, and raises the risk of heart failure or heart attack by 55 percent. Parker & Waichman, LLP represents victims of Trasylol and is actively evaluating claims on their behalf. For more information about Trasylol and the study published in the New England Journal of Medicine, please visit www.yourlawyer.com/topics/overview/trasylol or www.trasylol-lawsuit.com.

Trasylol was initially approved by the FDA in 1993 and is indicated to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass (CPB) in the course of coronary artery bypass graft surgery (CABG). While Trasylol is only approved for specific heart surgeries, it is commonly used for other surgeries including orthopedic procedures. Prior to the publication of the study reported in the New England Journal of Medicine, Bayer AG filed a request with the FDA seeking Trasylol approval for hip and spinal surgeries.

Trasylol, which is derived from the lungs of bovine, is significantly more dangerous than similar drugs used to reduce blood loss. The two generic drugs examined in the New England Journal of Medicine study, aminocaproic acid and tranexamic acid, were found to be significantly safer and just as effective as Trasylol. Furthermore, these generics are significantly less expensive than Trasylol; Trasylol costs more than $1,000 per patient versus $10 to $50 per patient for the generic drugs. The researchers estimated that using one of these generic drugs instead of Trasylol could prevent as many as 11,050 dialysis complications worldwide, and reduce drug costs by $250 million per year.

"This has all the signs of a drug that should not be on the market. It's more dangerous than the alternatives, which are just as effective. It's also more costly to patients and the healthcare system as a whole. There is no reason for this drug to be on the market today," said Jason Mark, an attorney with Parker & Waichman, LLP.

Most surgical patients are unaware of the medications they are given during the course of a surgical procedure. Trasylol is used during surgery, and it is therefore unlikely that patients would be aware that this drug was administered. For this reason, Parker & Waichman, LLP is encouraging all patients who suffered kidney failure, heart attack, heart failure or stroke after any surgical procedure to request a free case evaluation at www.yourlawyer.com/topics/overview/trasylol.

About Parker & Waichman, LLP

Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide, with 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. For more information on Parker & Waichman, LLP please visit: www.yourlawyer.com, or call 1-800-LAW-INFO (1-800-529-4636).

CONTACT: Parker & Waichman, LLP
         Jason Mark, Esq.
         (800) LAW-INFO OR (800)529-4636
         jmark@yourlawyer.com
         www.yourlawyer.com

Study: Cardiac Drug Doubles Risk of Kidney Failure

Thu, 26 Jan 2006 00:00:00 -0800

Aprotinin. a drug approved by the FDA, marketed internationally for the last 13 years, and given to an estimated one million surgery patients to limit bleeding has now been proven to double a patient's risk of kidney failure, and increase the risk of heart attack, heart failure, and stroke.

The results, published in this week's New England Journal of Medicine, are based on an independent, non-commercial, observational study conducted by The Ischemia Research and Education Foundation (IREF).

"Our study provides compelling evidence of aprotinin's serious risks, and strongly suggests discontinuation of use and replacement with either of the two alternative generic and far less costly medications proven safe in this study," said IREF founder and principal scientist, Dennis T. Mangano, Ph.D., M.D.

"Certainly, our findings coming on the heels of the Vioxx experience indicate that the problem of drug safety is not only ubiquitous, but also much more elusive than previously thought."

In fact, Mangano said, the findings raise even more troubling concerns, for:

(1) aprotinin has been on the market for three times as long as Vioxx, yet few comprehensive safety studies have been conducted since approval;

(2) the life-threatening complications with aprotinin occurred far more frequently than those with Vioxx; and

(3) far less expensive generic alternatives to aprotinin which are equally effective in limiting bleeding have been available, but have been underused.

The article states that replacing aprotinin with one of two safe generic drugs would annually prevent as many as 11,050 dialysis complications, save at least $1 billion in healthcare (dialysis) costs, and reduce drug costs by at least $250 million.

Each year approximately one million patients worldwide undergo surgical treatment following a heart attack, with the majority of these patients receiving one of three antifibrinolytic agents to limit blood loss during surgery: aprotinin (Bayer Healthcare Pharmaceuticals, Inc.), aminocaproic acid (generic), or tranexamic acid (generic).

The two generic drugs have proven safe in limiting blood loss, and do not have the harmful effects of aprotinin. Patients scheduled for cardiac surgery should consult their physicians and avoid this risk, Mangano said.

Aprotinin was approved by the U.S. Food and Drug Administration in 1993 and is manufactured by Bayer under the brand name Trasylol. Over the past three years, Trasylol sales have accelerated, with 2006 sales projected in excess of $600 million.

"We estimate that as many as 10,000 patients may be unnecessarily on dialysis today due to aprotinin use. This serious impact on human lives underscores once again the necessity for meticulous, post approval surveillance, as well as ongoing, unbiased analysis of drug safety all conducted by entirely independent entities," said Mangano.

"This is easier said than done, however, for the economic forces are and will continue to be substantial, with little corporate incentive to identify safety problems once drugs are approved and marketed."

The New England Journal of Medicine article documents how aprotinin use was associated with a two-fold increase in renal failure requiring dialysis in patients undergoing both complex coronary artery surgery and primary surgery, excluding prior cardiac and current valve surgery.

Among primary surgery patients, Dr. Mangano and colleagues found that aprotinin use also increased risk of myocardial infarction (48 percent), heart failure (109 percent), and stroke (181 percent).

Neither of aprotinin's generic competitors, aminocaproic acid and tranexamic acid, was associated with increased renal, cardiac or cerebral events.

Aprotinin is at least ten times more expensive than its generic competitors.

Clotting drug increases kidney risk, study finds

Thu, 26 Jan 2006 00:00:00 -0800

A drug commonly used to prevent excessive bleeding in heart-surgery patients greatly increased the risk of kidney failure, a new international study found.

The drug aprotinin marketed under the brand name Trasylol is the second clotting medication in two weeks linked to serious complications.

Heart-bypass patients who were injected with Trasylol during surgery had double the risk of kidney failure and an increased risk of heart problems compared with those who got other drugs, researchers reported in today's New England Journal of Medicine.

"Our findings raise serious concerns regarding the safety of an approved drug intended to limit blood loss in at-risk patients undergoing surgery," wrote Dr. Dennis Mangano of the Ischemia Research and Education Foundation, which led the study.

The San Bruno, Calif.-based foundation is a nonprofit organization founded in 1987 that funds cardiovascular research.

The Food and Drug Administration approved Trasylol in 1993 to control bleeding in patients undergoing open-heart surgery and minimize the need for blood transfusions. The drug works by blocking enzymes that dissolve blood clots.

Trasylol's maker, Germany-based Bayer AG, insists the drug is safe based on its own experiments but said it alerted regulatory authorities in the United States, Canada, Australia and Europe about the latest research.

Trasylol is the latest clotting drug to spark safety concerns. Last week, other researchers reported that the hemophilia drug Novoseven was linked to deaths, heart attacks and strokes in patients who took the drug to treat other types of excessive bleeding, such as cerebral hemorrhages.

Global sales for Trasylol reached $210 million in 2005, according to Bayer. Last month, chief executive Werner Wenning put the sales potential for the drug at more than $600 million.

Prescription Drug Kidney Failure Side Effect Injury Lawyer

Thu, 26 Jan 2006 00:00:00 -0800

Kidney Failure

Your kidneys play a vital function in this process by filtering the blood under high pressure and removing potential toxins, which are excreted from the body in the urine. Every day the kidneys filter the body's entire blood volume seven or eight times.

Kidney failure is a serious disease that can have a major impact on life, and can ultimately be fatal. When the kidneys start to fail, toxins are not filtered out of the blood, and start accumulates in the tissues. This can lead to a wide array of problems. Build up of two waste products, urea and creatinine, can lead to tiredness, weakness, loss of appetite and vomiting.

Kidney failure is also associated with an increase in the volume of water in the body, which can result in a swelling of the tissues. The common causes of kidney failure are glomerulonephritis (inflammation of the kidney) and diabetes mellitus. Other causes of kidney failure are kidney stones, kidney cysts, and an immune disorder called systemic lupus erythematosus, and uncontrolled high blood pressure.

As the kidneys begin to fail the following symptoms can begin develop:

Pale and sallow complexion
Fatigue
Shortness of breath
Body itch
Disruption of urination patterns
Poor appetite, sometimes accompanied with nausea and vomiting
Swelling of the face and legs

Prescription drugs such as Crestor and Trasylol have been associated with causing kidney failure.

On October 22, 2004, the consumer group Public Citizen said twenty-nine patients who took AstraZeneca's cholesterol drug Crestor developed kidney damage. Public Citizen states, the rate of reported kidney problems is approximately 75 times higher with Crestor than with all other drugs in the same class combined. According to its analysis, there have been 6.4 reports of acute kidney failure or kidney damage for every 1 million Crestor prescriptions filled. Trasylol, manufactured by Bayer, is an injectable drug used to prevent excessive blood loss during heart surgery. It has been found to double the risk of kidney failure.

If you or a loved one has been prescribed Accutane, Crestor or Trasylol and have been diagnosed with kidney failure, please fill out the form at the right for a free case evaluation by a qualified defective drug attorney.