Oct 25, 2007 5:14 pm US/Central
FDA: Heart Drug May Boost Risk Of Death
WASHINGTON (AP) ―
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The FDA said such changes, as well as other, unspecified regulatory actions, may result.
CBS
The Food and Drug Administration said Thursday that accumulating
evidence suggests a Bayer AG drug used to prevent excessive bleeding
during heart bypass surgery increases the risk of death when compared
with other drugs.
The announcement came as a Canadian study comparing the safety and
efficacy of the drug, Trasylol, with two others was halted. Preliminary
results from that trial also suggested Trasylol increased the risk of
death when compared with the other drugs. The trial was to include
3,000 patients.
Trasylol, also known as aprotinin, works by blocking enzymes that dissolve blood clots.
Bayer said it believes Trasylol remains a safe and effective
treatment option, but that the company would work with the FDA and
regulators in other countries to re-evaluate the drug's risks and
benefits and determine where any label changes are needed.
The FDA said such changes, as well as other, unspecified regulatory actions, may result.
The announcement came a month after FDA advisers recommended
Trasylol remain on the market despite its links to an increased risk of
death and other serious side effects.
The FDA approved it in 1993 to stanch the loss of blood and prevent
the need for blood transfusions in surgeries to bypass clogged coronary
arteries.
The agency began re-evaluating the drug's safety after 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 have suggested the drug also raises the risk of
death. One of those studies previously was withheld by Bayer from the
FDA due to what a company investigation later characterized as a
"regrettable human error."
(© 2009 The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.)
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