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August
8, 2001
RE: Market withdrawal of Baycol® (cerivastatin)
Dear Healthcare Professional:
I am writing to inform you of very important new safety information
about Baycol (cerivastatin) and rhabdomyolysis.
Rhabdomyolysis is a serious, potentially fatal, adverse effect of
all statin drugs, including Baycol. It can occur with statin
monotherapy, though the risk appears to be increased significantly
by concomitant use of gemfibrozil (Lopid).
Our ongoing scrutiny of post marketing reports of rhabdomyolysis,
including fatalities, has revealed an increased reporting rate of
rhabdomyolysis with Baycol relative to other statins, especially
when gemfibrozil is co-prescribed. These data also suggest an increased
reporting rate of rhabdomyolysis at the 0.8 mg dose of Baycol alone.
Bayer Corporation has already placed a contraindication in the Baycol
product prescribing information sheet against co-prescription with
gemfibrozil and issued letters to healthcare professionals warning
against co-prescription of these two drugs. Despite these and other
actions, Bayer has continued to receive reports of rhabdomyolysis
when gemfibrozil is prescribed as a co-medication. Since the co-prescription
of Baycol and gemfibrozil has continued despite communications by
Bayer against this practice, the company has decided to take the
following voluntary action to prevent further cases of rhabdomyolysis:
Effective immediately, Bayer
has discontinued the marketing and distribution of all dosage strengths
of Baycol. Patients who are currently taking Baycol should have
their Baycol discontinued and be switched to an alternative therapy.
Bayer is taking this action as part of an ongoing commitment to
patients and their healthcare providers to ensure patient safety.
It is important to you forward any adverse event information associated
with the use of Baycol to Bayer Corporation at 1-800-288-8371. You
can also report the information directly to the FDA via the MedWatch
system at 1-800-FDA-1088, by mail (using a postage paid form), or
the Internet at www.fda.gov/medwatch.
If you have further questions regarding this action on Baycol, please
contact Bayer customer service at 1-800-758-9794.
Yours
sincerely,
E. Paul Mac Carthy, MD
Vice President,
Head U.S. Medical Science
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