E-drug: Safety alert: Market withdrawal Cerivastatin
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Wednesday - August 8, 2001
Bayer withdraws cholesterol-lowering drug Baycol/Lipobay
Leverkusen-Bayer has withdrawn all dosages of its cholesterol-
lowering drug with the brand names Baycol/Lipobay (active
ingredient: cerivastatin) with immediate effect throughout the
world, except in Japan, and is withdrawing supplies of the product
currently in the market.
The reason for this voluntary action lies in increasing reports of side
effects involving muscular weakness (rhabdomyolysis), especially in
patients who have been treated concurrently with the active
substance gemfibrozil despite a contraindication and warnings
contained in the product information. Japan is unaffected by this
move because gemfibrozil is not available there.
"We have decided on this action in the interest of patient safety.
We will continue to conduct further assessments over the next few
months to evaluate the benefit/risk ratio of cerivastatin," explains
Dr. David Ebsworth, Head Manager of Bayer's Pharmaceuticals
Business Group. Any possible resumption of the marketing of
certain dosages of Baycol/Lipobay will be the subject of extensive
consultations between Bayer and the regulatory authorities.
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