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Drugs & Devices > Trasylol

FDA Issues Public Health Advisory for Trasylol

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.

If you or a loved one has suffered any injury or side effects from Trayslol you may be entitled to significant compensation.  Please contact us by completing the free case review or by calling us at 1-800-780-2686

Trasylol cited in two lawsuits
A lawsuit has been filed in Illinois St. Clair County Circuit Court on behalf of two heart surgery patients who received Trasylol injection before their operations to control bleeding... Read More
Study likely spells end for anti-bleeding drug
By LINDA A. JOHNSON, Associated Press Writer

An anti-bleeding drug probably will stay off the market, experts say, after a rigorous study found patients getting the medication during heart surgery were much more likely to die than patients given other drugs.
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Bayer Removes Remaining Trasylol Stock

Background: On Nov. 5, 2007, the Food and Drug Administration (FDA) announced that Bayer Pharmaceuticals Corp. agreed to an FDA-requested marketing suspension of Trasylol, a drug used to control bleeding during heart surgery. At that time, preliminary results from a Canadian study suggested an increased risk for death in patients taking Trasylol compared to two other drugs used to control bleeding.

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Trasylol Tied to nephritic dysfunction, study says
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