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New Study shows that Trasylol can increase doubling the risk of kidney failure, heart attacks, and strokes.
A recent national study reported in the New England Journal of Medicine has found that Trasylol , which is manufactured by Bayer Pharmaceuticals, may be linked to serious complications including kidney failure and heart problems. The study indicated Trasylol doubled the risk of kidney failure, stroke, a type of brain damage called encephalopathy, and also raised the chance of heart failure or heart attack by 55 percent.
Trasylol Quick Facts
- It is estimated that Trasylol may have been given to as many as 1 million patients who undergo heart bypass surgery.
- Trasylol costs more than $1,000 per patient versus $10 to $50 per patient for the generic drugs.
- The study examined 4,374 heart surgery patients worldwide and found that those on Trasylol were at twice the risk of suffering kidney failure, a heart attack or heart failure.
- Trasylol was approved in 1993 by the FDA and is commonly used to reduce blood loss and the need for blood transfusion in patients undergoing heart surgery.
- Trasylol , known generically as Aprotinin, is manufactured by Bayer Pharmaceuticals and has Global sales of $210 million in 2005, according to Bayer. Chief executive Werner Wenning put the sales potential for Trasylol at more than $600 million.
- 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.
How Trasylol Works
Trasylol also known as Aprotinin is an injectable drug which prevents patients undergoing various types of cardiac procedures (such as cardiac bypass surgery and coronary artery bypass grafts) from experiencing excessive blood loss. Trasylol also increases the risk of heart attack 48 percent, heart failure 109 percent and stroke 181 percent, according to a study in the New England Journal of Medicine.
Trasylol FDA Warning
On February 8th the FDA issued a Public Health Advisory for Trasylol . The Advisory was based on a study found in the New England Journal of Medicine which linked Trasylol to adverse events such as kidney (renal) failure, myocardial infarction, stroke, heart failure and heart attack.
While Bayer Phramaceuticals insists the drug is safe, the FDA released a statement calling the new study a "complicated analysis based on a large observational database" and said the agency is working to gather all available information and to evaluate the drug's safety.
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.
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.
Trasylol Research - New England Journal of Medicine
The 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."
The results, published in the 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."
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.
Bayer Disputes Findings
Bayer responded to the findings, claiming that the data were not in line with the 15 years of clinical data the company has collected. But the study's chief author, Dennis Mangano of the Ischemia Research and Education Foundation, said the results are clear and that with safer and less expensive alternatives available, Trasylol use is not prudent. Bayer has been hoping that Trasylol would be used in all types of surgeries.
Bayer withdrew Baycol, a member of the statin class of medicines, in August 2001 after some patients developed muscle weakening and kidney failure. The drug was linked to as many as 100 deaths.
FDA Issues Public Health Advisory for Trasylol
Feb 8, 2006 | www.fda.gov
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
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