Home » Drug Information » FDA-Approved Drugs » 1997
Medical Areas: Cardiology/Vascular Diseases | Endocrinology
View By: Year Company Therapeutic Areas Drug Names
Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Bayer
Approval Status: Approved June 1997; withdrawn 8/8/01
Treatment Area: Hypercholesterolemia
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.