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Bayer Removes Trasylol from the Market

If you or someone you know has been affected


The pharmaceutical company Bayer is removing remaining supplies of its heart-surgery drug Trasylol from the U.S. market after a long-awaited study found it raised the risk of death compared to two alternatives. A Canadian study by the New England Journal of Medicine showed patients given Trasylol had a more than 50 percent higher death rate than patients who received others.

Traysol, also known by its generic name aprotinin, has been widely used since the 1990s during heart bypass surgery to reduce bleeding. Bayer withdrew the drug temporarily in November 2007 advising it would re-evaluate its options once details from the new study, known as BART, were released.

The Food and Drug Administration removed the remaining Trasylol stock from the U.S. market. Access will be limited to investigational use for certain patients who have no acceptable alternatives. The research showed of 108 patients who died, the proportion who were believed to have died of cardiogenic shock, right ventricular failure, congestive heart failure or myocardial infarction (heart attack) was higher in the aprotinin group than in the other two groups.

The BART study was not the first to suggest problems with the drug. Since 2006, three studies have found evidence that it might increase the death rate, as well as the incidence of serious kidney damage and stroke.

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