Trasylol, a Heart Surgery Drug from Bayer

In 1993, the FDA approved the use of Trasylol (also known as aprotinin), a drug manufactured by Bayer Pharmaceuticals that is used to reduce bleeding and blood clotting in patients during heart surgery.

In the May 29, 2008 issue of the New England Journal of Medicine (May 29, 2008), the results from the Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART) study were released. The BART study is the first head-to-head comparison between Trasylol and two other alternative drugs that surgeons use to reduce bleeding. The study noted a significant absolute increase of 2.1%, or a relative increase of 54%, in the number of deaths in the Trasylol group compared to the alternatives. The cause of death for these patients included kidney failure, heart attack, and stroke.



The authors of the BART study terminated it early due to ethical concerns raised after the research showed that Trasylol doubled the risk of death versus the alternatives. According to lead researcher Dean A. Ferguson, “There was no way we could ethically enroll more patients in the trial because we had our answer.” An accompanying editorial to the study stated that “in all likelihood, this is the end of the aprotinin story.”

After the initial reports were given to the Food & Drug Administration (FDA) in November of 2007, Bayer agreed to temporarily suspend sales and marketing of Trasylol until the BART findings were finalized. Bayer has now notified the FDA that it will begin removing the remaining Trasylol stock in the U.S. Market from hospitals, warehouses and physicians' supplies.

Side effects of Trasylol include the following:
• Difficulty breathing or shortness of breath
• Fast heart beat
• Nausea and vomiting
• Skin rash, irritation or inflammation
• Sudden or severe pain in the chest, legs, head or groin
• Swelling of the face, lips, tongue or neck