Leverkusen, Germany - Bayer AG announced today that it is withdrawing all dosages of cerivastatin (Baycol®/Lipobay®) from the market immediately, except in Japan.
Increasing reports of fatal rhabdomyolysis, especially in combination with gemfibrozil, have prompted Bayer to act. A press release from the FDA notes that the agency has received reports of 31 deaths with cerivastatin, 12 of which had concomitant gemfibrozil use. The drug will, however, remain on the market in Japan, because gemfibrozil is not available there.
Bayer is withdrawing the drug to the pharmacy level. Patients taking cerivastatin are encouraged to consult their physicians about switching to another cholesterol-lowering treatment. Patients who are also taking gemfibrozil, or who are experiencing muscle pain, should discontinue the drug immediately and consult their physician.
"We have decided on this action in the interest of patient safety,? said Dr David Ebsworth, Head Manager of Bayer's Pharmaceuticals Business Group, in a press release from the company, "We will continue to conduct further assessments over the next few months to evaluate the benefit/risk ratio of cerivastatin."
Any possible resumption of the marketing of certain dosages of cerivastatin will be the subject of extensive consultations between Bayer and regulatory authorities.
For further information regarding the withdrawal of Baycol in the US, patients and physicians can contact Bayer Customer Service 1-800-758-9794 or the FDA's Drug Information Office at 301-827-4573 or 1-888-INFO-FDA.