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TRASYLOL LINKED TO KIDNEY FAILURE
by Jane Mundy
Trasylol was marketed by Bayer Pharmaceuticals Corp. to decrease the need for blood transfusions during surgery and was approved by the FDA in 1993. Trasylol (generic name Aprotinin) has since been used off-label in patients undergoing invasive procedures other than heart surgery.
Although Bayer studies indicated that Trasylol was toxic to the kidneys when it was first launched, the FDA approved the drug for high-bleed bypass operations only. In 1998, the FDA further approved Trasylol for any type of heart bypass operation. By 2005, it is estimated that 350,000 patients were injected with this drug, many unknowingly.
But Trasylol had a short life. A clinical trial, called the Blood Conservation Using Antifibrinolytics: A Randomized Trial in a Cardiac Surgery Population (BART) study, was funded by Bayer and conducted in Canada. This trial was suspended in October 2007 after preliminary review by its data safety committee appeared to identify an increased risk of death with the use of the drug. As a result of the BART study, on November 5, 2007 the FDA announced that Bayer agreed to suspend marketing its drug.
Even before the BART study was made public, On January 26, 2006, The New England Journal of Medicine (NEJM) published an article by Mangano et al. reporting an association of Trasylol with serious renal toxicity and ischemic events (myocardial infarction and stroke) in patients undergoing coronary artery bypass grafting surgery (CABG). Another publication (Transfusion, on-line edition, January 20, 2006) suggested an association between aprotinin administration and renal toxicity among patients undergoing cardiac surgery with cardiopulmonary bypass.
Not too many people knew about Trasylol until the TV program Õ60 minutesÕ caught the nationÕs attention. The show reported that the drug may be linked to more than 20,000 deaths in the US alone, and that Bayer withheld critical clinical information from the FDA. If this information had been available to the FDA sooner, the drug could have been recalled sooner and potentially have saved thousands of lives.
According to news reports, Bayer knew of TrasylolÕs adverse issues as far back as 2002, yet it was still used in heart related surgical procedures. Side effects include anaphylactic reactions, renal toxicity, kidney failure, stroke, heart attack and death.
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