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| |  Baycol (Cerivastatin) Not To Be Used In Combination With Gemfibrozil, Says Bayer TORONTO, ON -- July 25, 2001 -- The Healthcare Division of Bayer Inc. would like to advise consumers about important safety information for the cholesterol lowering drug, cerivastatin (Baycol®). Cerivastatin and gemfibrozil (another cholesterol-lowering drug) should never be used in combination due to the increased risk of a serious side effect. High cholesterol has long been recognized as a major factor contributing to heart disease and stroke. The Heart and Stroke Foundation of Canada report entitled, "The Changing Face of Heart Disease and Stroke in Canada 2000" states that drug treatment has been shown to reduce the rate of stroke as well as coronary heart disease mortality. Cerivastatin belongs to a class of drugs referred to as statins and is used by patients who have not been able to achieve a sufficient reduction of blood cholesterol levels with diet and exercise alone. Statins are known to cause a rare side effect of muscle breakdown. If you experience unexplained muscle pain, tenderness, or weakness at any time during treatment with cerivastatin, or nay other statin, you should notify your doctor immediately. In a very small percentage of patients, there is a risk of muscle breakdown resulting in kidney damage, which in rare instances can lead to life-threatening kidney failure. The risk of muscle breakdown is greater in patients taking gemfibrozil as well as other fibric acid derivatives (a group of cholesterol-lowering drugs), cyclosporine (an immunosuppressant), erythromycin (an antibiotic), azole antifungals, or lipid-lowering doses of niacin (nicotinic acid) together with statins including cerivastatin. In Canada, combination therapy with cerivastatin and gemfibrozil is rare, however if you are one of those few patients taking this combination, you should contact your doctor immediately. Cerivastatin and gemfibrozil should never be used in combination. Patients should be carefully monitored for any muscle pain, tenderness or weakness, particularly during the initial months of treatment, if the dose has been increased, or if the patient is a woman over 65 years in age. Cerivastatin was approved in Canada in March, 1998. Since launch, 31 cases of suspected muscle damage (out of 1.33 million total prescriptions) have been received in Canada, including eight cases resulting in kidney failure and one fatality. Muscle weakness is usually reversible if detected early and can be quickly and effectively treated. In March 2000, Bayer Inc. amended the cerivastatin prescribing information available to all health care professionals to indicate that cerivastatin and gemfibrozil must not be used together. A letter has been sent to Canadian doctors and pharmacists reminding them of this information. When used as directed, cerivastatin has a proven record of helping patients lower their cholesterol. Since 1997, over six million patients have been treated with cerivastatin worldwide and it is currently available in over 80 countries.
The following is a list of gemfibrozil products as provided by Health Canada for inclusion in this release: SCHEINPHARM GEMFIBROZIL SOURCE: Bayer Inc.
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