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Kennedy Hodges, L.L.P. Legal Blog

Thursday, May 29, 2008

Trasylol Forced Off Market

Trasylol (asprotinin) is a dangerous drug manufactured by Bayer Pharmaceuticals. It is used to reduce bleeding and blood clotting in patients during heart surgery. In the latest 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 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.

If you are looking for a Trasylol lawyer or a aprotinin lawyer, please call us at 713-523-0001. You can also reach a Trasylol attorney or aprotinin attorney toll-free at 877-342-2020.

posted by dhodges@kennedyhodges.com at 9:26 AM

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Kennedy Hodges, L.L.P. Legal Blog

Thursday, May 29, 2008

Trasylol Forced Off Market

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