Baycol (cerivastatin sodium)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved June 1997; withdrawn 8/8/01

Specific Treatments:

Hypercholesterolemia

General Information

Baycol (cerivastatin sodium), a new cholesterol-lowering agent by Bayer Corporation, was initially FDA approved in 1997. Baycol is a statin indicated as an adjunct to diet for patients with primary hypercholesterolemia and mixed dyslipidemia who have not responded adequately to dietary restrictions and other non-pharmacological measures. Baycol has been shown to be effective at relatively low doses at lowering LDL-cholesterol as well as total cholesterol and triglycerides.

However, the company voluntarily withdrew Baycol from the market on August 8, 2001 because of reports of sometimes fatal rhabdomyolysis, a severe muscle adverse reaction from the cholesterol-lowering product. The FDA received reports of 31 US deaths due to severe rhabdomyolsis from Baycol.