Bayer Pharmaceutical Division voluntarily withdrew cerivastatin (Baycol), their cholesterol-lowering medication, from the United States market in August because of a side effect called rhabdomyolysis that was linked to 52 deaths worldwide. Symptoms of rhabdomyolysis, an acute condition where muscle cells are destroyed and released into the bloodstream, include severe muscle pain usually in the calves or lower back, weakness, tenderness, fever, dark urine, nausea and vomiting, and can lead to the development of fatal kidney or other organ failure. While all of the popular anticholesterol drugs known as statins have been linked to rare reports of rhabdomyolysis, the U.S. Food and Drug Administration (FDA) linked Baycol to significantly more fatal cases. The FDA stated that this side effect of Baycol was reported most frequently when used at higher doses, when used in the elderly, and especially when used in combination with gemfibrozil, another lipid level lowering drug. The FDA recommends that the 700,000 Americans currently taking Baycol consult their physician about switching to alternate medications to control their cholesterol levels. For more information regarding the withdrawal of Baycol, contact Bayer Customer Service at 800-758-9794 or the FDA's Drug Information Office at 888-INFO-FDA, or visit http://www.fda.gov/bbs/topics/ANSWERS/ 2001/ANS01095.html.
COPYRIGHT 2001 American Academy of Family Physicians
COPYRIGHT 2001 Gale Group