BAYCOL

The FDA announced on August 8, 2001 that Bayer Pharmaceutical Division is voluntarily withdrawing Baycol (cerivastatin) from the U.S. market because of reports of sometimes fatal rhabdomyolysis, a severe muscle adverse reaction from this cholesterol-lowering (lipid-lowering) product. The FDA agreed with and supported Bayer’s decision. There have been 35 reported deaths linked to Baycol.

Rhabdomyolysis is a potentially life-threatening condition that occurs when a large number of skeletal muscle cells die, which results in the release of a massive amount of muscle protein (known as myogloblin) into the bloodstream. The muscle protein can become trapped in the kidneys, clogging up the filtering process of the kidneys and leading to kidney or renal failure. In addition, potassium released from the damaged muscle cells can cause malignant heart rhythms resulting in cardiac arrest.

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.
One of the principal allegations in the Baycol lawsuits and Baycol class actions is that following the drug's introduction, Bayer began receiving mounting clinical evidence and reports from physicians of serious side effects with the drug.