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Cerivastatin (BAYCOL®) And Gemfibrozil - Increased Risk of Rhabdomyolysis - Concomitant Use Contraindicated

Date: 2001-07-16

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IMPORTANT DRUG SAFETY INFORMATION

July 16, 2001

Dear Health Care Professional:

In March 2000 Bayer Inc., Canada amended the cerivastatin Product Monograph to include a contraindication with gemfibrozil. This letter is intended to remind health care professionals that the combined use of cerivastatin and gemfibrozil is contraindicated due to the risk of rhabdomyolysis and concurrent use should not occur under any circumstances. Post-marketing spontaneous reports have highlighted the increased incidence of rhabdomyolysis in patients receiving cerivastatin and gemfibrozil concomitantly.

Between March 1998 and June 30, 2001, 31 cases of suspected rhabdomyolysis (out of 1.33 million total prescriptions) have been received in Canada, including 8 cases resulting in renal failure and 1 death. Of these 31 cases, 9 occurred in patients receiving concurrent gemfibrozil treatment. Adverse event rates determined on the basis of spontaneously reported post-marketing adverse reaction reports are generally presumed to underestimate the risks associated with drug treatments.

Rhabdomyolysis is a potentially life-threatening condition and is characterized by markedly elevated CPK levels ( > 10x the upper limit of normal), myoglobinaemia and myoglobinuria which may lead to renal failure. Patients taking BAYCOL® should be made aware of rhabdomyolysis as a potential side effect and advised to promptly report to their doctors or pharmacists any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. BAYCOL® and gemfibrozil must be discontinued if any significant elevation of CPK level occurs, or if myopathy is suspected or diagnosed.

The risk of rhabdomyolysis with HMG-CoA reductase inhibitors (statins) is thought to be related to plasma concentrations.

Please also note the exact wording from the dosing and administration section of the Product Monograph is as follows:

"The recommended starting dose is 0.2 mg once daily in the evening. The recommended dosing range is 0.2 - 0.8 mg as a single dose in the evening. BAYCOL® may be taken with or without food since there are no apparent differences in the lipid lowering effects of BAYCOL® administered with the evening meal or at bedtime. Dosages should be individualized according to the recommended goal of therapy and the patient's response".

The identification, characterization, and management of drug-related adverse events are dependent on the active participation of health care professionals in adverse drug reaction reporting programmes. Any occurrences of rhabdomyolysis or other serious and/or unexpected adverse events in patients receiving BAYCOL® should be reported to the Bayer Inc., Healthcare Division or the Bureau of Licensed Product Assessment at the following addresses:

Dr. Sandra Tsai
Drug Safety and Medical Information
Bayer Inc., Healthcare Division
77 Belfield Road
Toronto, Ontario M9W 1G6
1-800-268-1331
sandra.tsai.b@bayer.com

Your professional commitment in this regard has an important role in protecting the well-being of your patients by contributing to early signal detection and informed drug use.

Sincerely

original signed by

Dr. Neil S. Maresky
Vice President
Medical and Scientific Affairs
Bayer Inc., Healthcare Division

®BAYCOL, Bayer and Bayer Cross are trademarks of Bayer AG, used under licence by Bayer Inc.

BA470-0701E