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Bayer decides to withdraw cholesterol lowering drug
Fred Charatan, Florida
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1997, has been withdrawn by the manufacturer.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……………
© BMJ, August 18, 2001
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