Important Medical Notice - BAYCOL -
MEDICAL ALERT
Baycol removed from market
BAYCOL
On August 8, 2001, Bayer voluntarily withdrew Baycol, (cerivastatin) from the U.S. market because of reports of sometimes fatal rhabdomyolysis, a severe adverse muscle reaction from this cholesterol-lowering product. The Food and Drug Administration (FDA) agreed with and supported Bayer’s decision.
Baycol, initially approved in the U.S. in 1997, is a member of a class of cholesterol-lowering drugs that are commonly referred to as "statins." Statins lower cholesterol levels by blocking a specific enzyme in the body that is involved in the synthesis of cholesterol. While all statins have been associated with very rare reports of rhabdomyolysis, cases of fatal rhabdomyolysis in association with use of Baycol have been reported significantly more frequently than for other approved statins.
Fatal rhabdomyolysis reports regarding Baycol have been reported most frequently when used at higher doses, when used in elderly patients, and— particularly— when used in combination with another lipid-lowering drug called gemfibrozil (Lopid brand and generics). The FDA has received reports of 31 U.S. deaths due to severe rhabdomyolysis associated with the use of Baycol.
Rhabdomyolysis is a condition that results in muscle cell breakdown and release of the contents of muscle cells into the bloodstream. Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting. The pain may involve specific groups of muscles or may be generalized throughout the body.
Most frequently, the involved muscle groups are the calves and lower back; however, some patients report no symptoms of muscle injury. In rare cases, the muscle injury is so severe that patients develop renal failure and other organ failure, which can be fatal.
Patients taking Baycol should consult with their physicians about switching to alternate medications to control their cholesterol levels; those who are experiencing muscle pain or are also taking gemfibrozil should discontinue Baycol immediately and consult their physician.
