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The controversial Bayer AG drug Trasylol, used to prevent blood loss in heart-bypass patients, should remain on the market, a Food and Drug Administration panel recommended yesterday.
Trasylol has been linked to an increased risk of kidney failure, heart failure, stroke and death. Despite these risks, panel members voted 15 to 1 in favor of keeping Trasylol on the U.S. market. One panel member declined to vote.
Rather than remove Trasylol from the market, panel members recommended additional studies be conducted to further examine the drug's safety.
Recent Studies Highlight Risks
Two studies published in 2006 linked Trasylol to a two-fold increased risk of kidney failure, and two additional studies published since then suggested the drug also increased the risk of death.
The first study to draw attention to a possible risk of death is known as the 13 drug study and it found that Trasylol increased this risk by more than 50 percent. A second study published earlier this year in the Journal of the American Medical Association had similar findings.
Labeling Changes
However, panel members said these studies were not conclusive and are only recommending that the labeling of Trasylol be updated to discuss the potential risk of death.
“We need to provide something in the label to say we are worried about it,” said Michael Lincoff of the Cleveland Clinic.
The FDA updated Trasylol's label in December with a black box warning on the increased risk of kidney damage. According to the warning, Trasylol should only be administered to heart surgery patients who are at a high risk of blood loss.
(Source: The Wall Street Journal online)
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