Baycol (cerivastatin) Withdrawn from the U.S. Market
Volume XI, Issue 6
Richard Pasternak, MD Director of Preventive Cardiology and Cardiac Rehabilitation Program

On August 8, 2001, Baycol (cerivastatin) was withdrawn from the worldwide market (except Japan) by its manufacturer, Bayer. The rationale behind the removal was the unacceptably high incidence of rhabdomyolysis seen with Baycol use, especially when combined with gemfibrozil. The FDA reports that it has received 31 reports of death of patients in the U.S. who were being treated with Baycol. Twelve of the 31 patients were also taking gemfibrozil. Despite warnings issued by the FDA and manufacturers for all of the statins, detailed in the prescribing information, the incidence of gemfibrozil-Baycol-related rhabdomyolysis continued to be unacceptably high, according to a press release issued by Bayer (http://www.news.bayer.com/news/news.nsf/ID/01-0219). The problem also appears to have been related to use of the 0.8 mg dose, especially when patients were started on that dose. Baycol is not routinely prescribed within the PCHI network, but is used for about 4-5% of patients on a statin. You will likely soon begin to receive calls from your patients as the news media report on the drug's withdrawal. For patients who have been on Baycol for some time, there is no immediate worry. For those just starting (especially at higher doses), the concern is slightly greater. In any case, you will need to begin to convert patients from Baycol to another statin. For conversion purposes: Baycol 0.4mg is equivalent to Lescol 80mg ($54.90/30 day supply*), Lipitor 10mg ($63.56/30 day supply*), Pravachol 40mg ($124.19/30 day supply*), Zocor 20mg ($124.90/30 day supply*), and Mevacor 40mg ($135.73/30 day supply*). Lescol and Lipitor are the preferred replacement drugs for Baycol based on cost of therapy. It is important to note that the combination of gemfibrozil and any of the remaining statins is associated with an increase in the incidence of rhabdomyolysis. The benefits of this combination on serum lipid levels must be weighed against the increased risk of rhabdomyolysis. *Please note:all prices listed are based on Average Wholesale Price as listed in the Red Book. Additional information may be obtained at the following link.