-September 13, 2007
A federal advisory panel voted to keep the medication, aprotinin, on the market, despite the serious risks associated with the drug.
Bayer AG sells the drug under the brand name Trasylol.
Risks Associated with the Drug
According to recent studies, the medication, which is used to prevent excessive bleeding during bypass surgery, poses high risks of kidney problems, heart attacks, strokes and death.
Although Bayer claims the drug reduces the risk of blood transfusions in patients, they do openly admit that it appears to cause kidney problems and possibly even kidney failure.
FDA Issued Warnings in the Past
The FDA has been re-evaluating the drug and its risks since studies were published linking the medication to health complications.
In December, the FDA strengthened the “black box” warnings and advised only patients who face a serious risk of blood loss to use aprotinin.
A federal advisory panel voted 16-1 to keep the drug on the market.
Although the FDA is not required to adhere to the advise of federal advisory panels, they typically do.
(Source: Associated Press)
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