Case Evaluation

Baycol: Baycol Overview

Baycol was approved for use in the U.S. in 1997, and is a member of a class of cholesterol lowering drugs that are commonly referred to as "statins." Statins such as Baycol 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 the use of Baycol have been reported significantly more frequently than for other approved statins.

On August 8, 2001, Bayer Pharmaceutical Division announced that it was voluntarily withdrawing Baycol (cerivastatin) from the U.S. market because of reports of sometimes fatal rhabdomyolysis, a severe adverse reaction that can result from Baycol use. A flood of legal claims began soon after the recall, brought by Baycol users and their loved ones who suffered harm from side effects of the anti-cholesterol drug. As of January 2004, Bayer estimated that it had settled over 2,000 Baycol-related claims out of court, and still faces over 10,000 existing lawsuits.

About Rhabdomyolysis

Rhabdomyolysis is a condition that results in muscle cell breakdown and the release of the contents of muscle cells into the bloodstream. Symptoms of rhabdomyolysis include:

  • Muscle weakness, tenderness, and pain
  • Dark or rust-colored urine
  • Joint pain
  • Seizures
  • Fever
  • Nausea
  • Vomiting
  • Fatigue

The pain may involve specific groups of muscles, or may be generalized throughout the body.

Most frequently, affected 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. Fatal rhabdomyolysis has been reported most frequently when Baycol was used at higher doses, used by elderly patients, and particularly when used in combination with gemfibrozil (LOPID and generics), another lipid lowering drug.

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