Date:
11/05/2007 07:25 AM
FDA asks Bayer to suspend sales of heart drug pending further
scrutiny over death risk
WASHINGTON
(AP) _ The government has asked Bayer Pharmaceuticals to suspend
sales of a drug used to prevent excessive bleeding during
heart bypass surgery that may increase the risk of the patient's
death.
The Food and Drug Administration said Monday
that Bayer AG has agreed to stop selling the drug, Trasylol,
pending detailed review of preliminary results from a Canadian
study that suggested an increased risk of death. The study
comparing the safety and efficacy of the drug, Trasylol, with
two others was recently halted.
Trasylol, also known as aprotinin, works by
blocking enzymes that dissolve blood clots.
There are not many treatment options for patients
at risk for excessive bleeding during cardiac surgery, the
FDA noted in its announcement. The agency said it was working
with Bayer to phase Trasylol out of the marketplace in a way
that does not cause shortages of other drugs used for this
purpose.
Bayer has 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 announcement came more than 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.
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On the Net:
FDA information on Trasylol: http://tinyurl.com/2c43mu
