FDA to revisit Trasylol death risk

Another red flag has risen at the FDA. The agency is warning that Trasylol, the Bayer drug used to prevent excess bleeding during heart surgery, increases the risk of death.

The FDA's action was prompted by the shutdown of a Canadian study; early data from that research showed "a trend toward increased mortality," the agency said.

Bayer says it believes Trasylol is still safe and effective, but it will work with the agency to determine whether and how its labeling should change. Meanwhile, the FDA said that it will re-evaluate the drug's safety and efficacy; label changes and other regulatory action may follow.

Just a month ago, an FDA advisory committee voted to keep Trasylol on the market despite reports of serious side effects, including kidney problems, heart attack, and stroke. And that committee meeting followed news that Bayer withheld data showing the drug increased the risk of death; an internal investigation blamed the buried data on human error.

-read the press release from Bayer
-read the early warning from the FDA
-read the story at the Los Angeles Times

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