The Pharmaceutical Journal Vol 267 No 7160 p181-186
11 August 2001

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Sudden withdrawal of cerivastatin by Bayer

Cerivastatin (Lipobay) is to be withdrawn with immediate effect because of concerns over safety.

Bayer announced on 8 August that all strengths of cerivastatin are being withdrawn. Supplies that have already been distributed will be recalled. The company advises that any patient who is taking cerivastatin should contact their doctor to review their therapy.

Bayer says that it continues to receive reports of muscle toxicity (myopathy and rhabdomyolysis) following the concomitant use of cerivastatin and gemfibrozil, despite precautions taken to avoid their co-prescription (PJ, 7 July). Following discussions with the United States Food and Drug Administration, the company concluded that the effects of co-prescription with gemfibrozil are more pronounced with cerivastatin than with other statins.

Although reports of serious adverse events related to concomitant use of cerivastatin and gemfibrozil have been lower in Europe than in the US, Bayer has decided to suspend marketing and distribution of cerivastatin worldwide, except in Japan where gemfibrozil is not available.

Bayer says that it will conduct assessments to evaluate the role of cerivastatin over the next few months and will then make a decision, in conjunction with the regulatory authorities, regarding its possible reintroduction.

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