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August
8, 2001
RE:
Market withdrawal of Baycolâ (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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