The voluntary withdrawal of Bayer's (Leverkusen, Germany) cholesterol-lowering drug cerivastatin (Baycol/LipoBay) at the beginning of August was clearly a major setback for the company, but the implications of the move sound warnings for the pharmaceutical industry outside Leverkusen. In particular, they may have repercussions for those drug companies that have merely stood still too long and are now being left behind in R&D and in marketing by mega-mergers.
Bayer withdrew the drug as a result of post-marketing surveys (phase IV) that found an increased occurrence of the muscle-wasting disease rhabdomyolysis in patients given the drug. The US Food and Drug Administration (Rockville, MD) sent out a “Dear Healthcare Professional” letter on August 8 announcing that Bayer had withdrawn the drug. It pointed out that rhabdomyolysis was an adverse effect of all statins, the class of compounds to which cerivastatin belongs, but that there was “an increased reporting rate of rhabdomyolysis with Baycol relative to other statins.” This was especially the case when the drug was given with gemfibrozil, a drug that lowers triglyceride and low-density lipoprotein, or when the higher dose of cerivastatin was prescribed.
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