http://bmj.com/cgi/content/full/323/7309/359/a
BMJ 2001;323:359 ( 18 August )
Fred Charatan
Cerivastatin (Baycol in the United States, Lipobay in the United Kingdom), a
cholesterol lowering drug made by Bayer Corporation and initially
approved in the US in 1997, has been withdrawn by the
manufacturer. There have been 31 deaths in the US from severe rhabdomyolysis
in patients taking the drug. Twelve patients were taking concomitant
gemfibrozil, which lowers blood concentration of triglycerides.
Rhabdomyolysis, a serious and potentially fatal adverse effect of all statin
(cholesterol lowering) drugs, is about 10 times more common
with cerivastatin than with other statins, according to Dr John
Jenkins, director of the office of drug evaluation at the US Food
and Drug Administration (FDA).
Fatal rhabdomyolysis after cerivastatin treatment has been reported most
frequently when the drug is given at high doses, when it is used in
elderly patients, and particularly when it is prescribed with gemfibrozil.
In a letter to health professionals dated 8 August 2001, Bayer
said that its data indicated "an increased reporting rate of rhabdomyolysis
at the 0.8 mg dose of Baycol alone." The FDA agreed with
and supported Bayer's decision to withdraw cerivastatin from the US
market.
In a "Talk Paper" the FDA wrote: "Patients who are taking
Baycol should consult with their physicians about switching to alternative
medications to control their cholesterol levels. Patients taking Baycol
who are experiencing muscle pain or are also taking gemfibrozil should
discontinue Baycol immediately and consult their physician.
"There are five other statins available in the US that may be
considered as alternatives to Baycol. They are: lovastatin (Mevacor), prevastatin
(Pravachol), simvastatin (Zocor), fluvastatin (Lescol), and
atorvastatin (Lipitor)."
The United Kingdom's Medicines Control Agency has issued similar advice that
patients who are currently taking cerivastatin should change
treatment when their next prescription is due. Doctors should recall
for review any patients taking cerivastatin with gemfibrozil. Any
patient being treated with cerivastatin who feels unwell,
particularly with fever or muscle pain, should seek medical advice,
the agency says.
Meanwhile the European Agency for the Evaluation of Medicinal Products has
announced that it plans to review all other cholesterol lowering
drugs, as a precautionary measure.
© BMJ 2001
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