To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Significant Risk of Cardiovascular Toxicity Associated with Schizophrenia Drug Clozaril (Clozapine) URL: http://www.pslgroup.com/dg/212B9E.htm Doctor's Guide January 21, 2002
DORVAL, QC -- January 21, 2002 -- After discussions with Health Canada, Novartis Pharmaceuticals Canada is alerting schizophrenia patients/guardians and physicians of emerging safety information concerning the cardiac effects of clozapine, a medication sold in Canada under the tradename Clozaril®. Clozaril is an atypical antipsychotic medication, prescribed for patients with treatment-resistant schizophrenia. Clozaril has been available in Canada since 1991.
Analysis of safety databases suggests that the use of clozapine is associated with an increased risk of myocarditis, an inflammation of the muscular walls of the heart. Clozapine is associated with this increased risk especially during, but not limited to, the first month of therapy.
Specifically, myocarditis has been reported in patients 19 years of age and older, at dosages within the approved dosage range and during titration of clozapine. In Canada, there have been nine reported cases of myocarditis. Of these, three have been fatal. Given the estimated 15,600 Canadian clozapine-treated patients as of August 2001, this represents an estimated incidence of 0.06 percent for all reports of myocarditis (or 1/1667 patients) and 0.02 percent for myocarditis fatalities (or 1/5200).
Other cardiovascular events, including pericarditis, pericardial effusion and cardiomyopathy have also been reported in association with clozapine use, as have heart failure, myocardial infarction and mitral insufficiency; these reports include fatalities.
Patients should contact their physician immediately if they develop persistent tachycardia (rapid heart rate) at rest accompanied by other signs and symptoms of heart failure (chest pain, shortness of breath, swelling of the ankles and feet, or arrhythmias). Other symptoms which may be present in addition to the above include fatigue, flu-like symptoms, fever that is otherwise unexplained, hypotension (low blood pressure) and/or raised jugular venous pressure (bulging neck veins when sitting or standing). Patients are advised to contact their physician before discontinuing any medication.
The occurrence of such signs and symptoms necessitates an urgent diagnostic evaluation for myocarditis, cardiomyopathy and/or other cardiovascular dysfunction by a cardiologist (referral to cardiologist will be needed by treating physician). Patients with a family history of heart failure should have a cardiac evaluation prior to commencing treatment; clozapine is contraindicated in patients with severe cardiac disease.
The occurrence of myocarditis and other cardiovascular-related adverse events in association with Clozaril has been included in the Product Monograph since the launch of the product in Canada in 1991. The monograph has since been updated several times to provide further information on emerging safety data regarding myocarditis, the last update being issued in June 2000.
Novartis is committed to patient safety, and is now alerting patients/caregivers to be aware of possible symptoms of these potentially fatal conditions, including cardiomyopathy, and to discuss them with their physicians.
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