Bayer AG has agreed to an FDA request to withdraw its heart surgery drug Trasylol from the market, after the drug came under fire in the wake of a Canadian study suggesting that it increased death rates. Trasylol, known generically as aprotinin, has been on the market since 1993, and was taken by about 110,000 U.S. patients last year. However, it has been dogged by safety questions.
Most recently, researchers at the Ottawa Health Research Institute recently stopped a study of the drug in 3,000 heart bypass and valve surgery patients due to some questionable outcomes. Specifically, the researchers found that although the drug reduced bleeding, patients taking it were half again as likely to die as those given two older, alternative drugs. (However, the researchers conceded that it's not clear whether the deaths could be attributed to the drug, given the early closure of the study and questions about the statistical validity of conclusions drawn from a small sample of events.) Previously, a New England Journal of Medicine study suggested that the drug could increase risks of kidney failure, heart attack and stroke.
After working with expert panels, and suggesting that the drug be given only to patients with great risk of excessive bleeding, the FDA has now asked that the drug be taken off the market--and German regulators have insisted on the withdrawal.
To learn more about the controversy:
- read this piece from The New York Times
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