Defective Drugs – Baycol

Baycol is a prescription drug manufactured by Bayer A.G. Pharmaceutical to lower cholesterol. It belongs to the statin class of drugs, which lower cholesterol by blocking enzymes that are essential to the production of cholesterol in the body. Baycol was approved by the FDA for sale in the United States in 1997 and has been very effective in reducing cholesterol levels and thus reducing the likelihood a heart attack.

However, it has become apparent that the drug may sometimes cause fatal rhabdomyolysis. This is a condition that results in muscle cell breakdown and release of the muscle cells into the bloodstream, causing kidney failure. Although all statins have been associated with very rare reports of rhabdomyolysis, fatal cases in association with the use of Baycol have been higher than with other statins. There have been over 50 deaths to date. Fatal rhabdomyolysis is most frequent when the Baycol drug is used at higher doses, or when the patient is elderly. In particular, it is dangerous if it is used in combination with gemfibrozil (another lipid lowering drug).

In August 2001 Bayer voluntarily withdrew the drug from the United States market, with the FDA supporting the company’s decision. Patients who have been taking Baycol should switch to an alternative medication to control their cholesterol levels. There are currently five other statins available in the United States that may be considered as an alternative to Baycol: lovastatin (Mevacor), pravastatin (Pravachol), simvastatin (Zocor), fluvastatin (Lescol) and atorvastatin (Lipitor).

Action against the company, for death or permanent disorder, is presently ongoing.