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Trasylol Pulled From World Market by Bayer AG

Nov 7, 2007 | Parker Waichman LLP

Trasylol, an anti-bleeding medication, was pulled from the market earlier this week following concerns that it put patients at a high risk of death.  The German pharmaceutical firm Bayer AG announced that it would stop worldwide sales of Trasylol after a Canadian Trasylol study was suspended after a data analysis found that patients treated with Trasylol had higher risk of death than other patients in the trial. Trasylol is the trade name for aprotinin, approved by the FDA in 1993. Approximately 200,000 patients around the globe used the product last year, more than half of them in the United States. The drug decreases bleeding during surgery, making risky transfusions unnecessary. Worldwide sales so far in 2007 total approximately $135 million, according to Bayer, with $91 million of those sales within the U.S. Trasylol blocks the enzymes that dissolve blood clots.

Two other older drugs are also used for this purpose. A clinical study by the Ottawa Health Research Institute was evaluating Trasylol versus the other drugs in 3,000 valve-surgery and heart bypass patients. When the study indicated that the drug was more effective in stopping bleeding – but caused 50% more deaths than the other two alternatives due to hemorrhage – the Canadians halted the medical trial.

After a preliminary review of the Canadian findings, the U.S. Food and Drug Administration asked Bayer AG to stop selling the drug. Just a month ago, the FDA had recommended keeping Trasylol on the market, despite preliminary reports about serious side effects and potential increase in fatalities. The agency’s Dr. John Jenkins, who heads the FDA’s Office of New Drugs, denied that the earlier recommendation was a mistake, even though the regulatory group now says it “cannot identify a specific patient population where we believe the benefits of using Trasylol outweighs the risk.” Bayer is reported to have withheld an earlier unfavorable study from the U.S. agency due to a “regrettable human error.”

Bayer’s withdrawal of Trasylol coincided with the annual meeting of the American Heart Association (AHA) in Orlando, FL. Physicians attending the scientific gathering had mixed feelings about the drug’s withdrawal. The AHA spokesman Dr. Timothy Gardner said that Trasylol was “particularly useful for certain patients.” The drug’s official web page within the Bayer AG site claims that Trasylol “breaks the chain of events caused by bypass-induced SIRS (systemic inflammatory response syndrome).” An update on the same site announces Bayer’s suspension of sales around the world, but describes the suspension as  “temporary.” Bayer AG is based in Frankfurt, Germany. Referring to the Canadian study, Bayer said it would “work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol."


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