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8/8/2001

Cerivastatin Withdrawn From Market

Cheryl A. Thompson

Bayer Corp. has withdrawn its cerivastatin product, Baycol, from the market because of ongoing reports of rhabdomyolysis related to therapy with the drug, the company announced yesterday. Health care professionals are being told by the company to discontinue patients' cerivastatin therapy and prescribe another lipid-lowering agent.

Thirty-one people in the United States have died of severe rhabdomyolysis linked to the use of cerivastatin, the Food and Drug Administration (FDA) said. Twelve of these people were also taking gemfibrozil, a fibric acid derivative used in antilipemic therapy. Fatal cases of rhabdomyolysis, which involves the breakdown of muscle cells, have been reported significantly more often with the use of cerivastatin than with the use of atorvastatin, fluvastatin, lovastatin, pravastatin, and simvastatin, FDA said.

Bayer began marketing Baycol in 1997. The labeling was revised twice in 1999—first to warn about the rare occurrence of rhabdomyolysis during statin therapy, and then to state that the combined use of cerivastatin and gemfibrozil was contraindicated. In May 2001, the company sent health care professionals a letter advising them to start cerivastatin therapy at a daily dose of <0.4 mg to decrease the likelihood of rhabdomyolysis.

Despite the changes in labeling and communication with health care professionals, Bayer said it continued to receive reports about the combined use of cerivastatin and gemfibrozil and the occurrence of rhabdomyolysis.

The company's decision to withdraw Baycol applies worldwide except in Japan, where gemfibrozil is not available. Outside the United States, cerivastatin may be marketed as Lipobay.

23 August 2001, Update—Bayer announced today that it will withdraw Baycol from Japan because the country's health authorities said gemfibrozil would soon be available there.

FDA said Bayer will instruct pharmacies to return their supplies of Baycol to the company for a refund. The company is fielding questions about the recall at 800-758-9794.