Warning

2001-89
August 10, 2001

Voluntary withdrawal of Baycol

OTTAWA - Health Canada would like to advise Canadians that effective August 8, 2001 the manufacturer Bayer Inc. has voluntarily suspended the marketing and distribution of Baycol from the Canadian market because of reports of rhabdomyolysis associated with this product. Bayer is taking similar action in all other countries except Japan. Health Canada concurs with Bayer's decision to remove Baycol products from the Canadian market.

Baycol (cerivastatin) was approved in Canada on February 18, 1998. It is a member of a class of cholesterol-lowering drugs that are commonly referred to as "statins".

Baycol appears to be associated with an increased reporting rate of rhabdomyolysis relative to other cholesterol-lowering drugs of the statin class currently available on the market. The incidence of rhabdomyolysis with the use of Baycol has been reported more frequently at higher doses, particularly when used in combination with gemfibrozil, another lipid lowering drug.

Rhabdomyolysis is a condition that results in muscle breakdown and the release of muscle cell contents into the bloodstream. Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, fever, dark urine, nausea, and vomiting. In severe cases rhabdomyolysis can result in kidney failure.

Between March 1998 and August 8, 2001, 45 cases of rhabdomyolysis, including 14 cases of acute renal failure and one death were reported in Canada.

Health Canada instructed Bayer Inc. to issue a Dear Health Care Professional Letter (DHCPL) on July 16, 2001 and a Public Advisory on July 25, 2001 to inform physicians, pharmacists and patients about the risks of rhabdomyolysis associated with Baycol. A second DHCPL was issued on August 8, 2001 advising health care providers of the market withdrawal of Baycol.

Patients who are currently taking Baycol are advised to contact their physician immediately about switching to alternate medications to control their cholesterol levels. For further information regarding the withdrawal of Baycol, patients and physicians can contact Bayer Customer Service 1-800-265-7382

Media inquiries:
Roslyn Tremblay
Health Canada
(613) 957-1588