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Bayer’s Trasylol Will Remain in Market Despite Increased Risk of Death
September 14, 2007 at 12:14 PM
Drug News
The injectable drug is used to prevent excessive blood loss during heart surgery brought on by the blood thinner heparin and mechanical tubing used in the heart-bypass machine.
The FDA had approved it in 1993 to stanch the loss of blood and prevent the need for blood transfusions in surgeries to bypass clogged coronary arteries.
A joint panel of FDA expert advisers voted Wednesday 6-1, with one abstention, to recommend allowing sales of the drug to continue, an agency spokeswoman said. The FDA is not required to follow the advice of its advisory committees but does so most of the time.
The FDA has been re-evaluating the drug's safety since the January 2006 publication of two studies that linked the drug's use to serious side effects, including kidney problems, heart attacks and strokes.
More recent studies, including one done by Bayer themselves, have suggested the drug also raises the risk of death.
Bayer said Trasylol has been shown to reduce the risk of blood transfusion. The company allows that the drug appears to be associated with kidney dysfunction, but says any link to kidney failure is less definitive, according to documents released ahead of Wednesday's meeting.
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