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A new warning has been added to the Boxed Warnings section of the package insert for clozapine (Clozaril). The warning states: Analyses of post-marketing safety databases suggest that clozapine is associated with an increased risk of fatal myocarditis, especially during, but not limited to, the first month of therapy. In patients in whom myocarditis is suspected, clozapine treatment should be promptly suspended. The full text of the PI is available at http://www.fda.gov/medwatch/SAFETY/2002/Clozaril_PI.pdf Novartis, the manufacturer of Clozaril, sent a Dear Doctor letter stating in part, "Post-marketing surveillance data from four countries that employ hematological monitoring of clozapine-treated patients revealed: 30 reports of myocarditis with 17 fatalities in 205,493 U.S. patients (August 2001); 7 reports of myocarditis with 1 fatality in 15,600 Canadian patients (August 2001); 30 reports of myocarditis with 8 fatalities in 24,108 U.K. patients (August 2001); 15 reports of myocarditis with 5 fatalities in 8,000 Australian patients (March 1999). These reports represent an incidence of 5.0, 16.3, 43.2, and 96.6 cases/100,000 patient years, respectively. The number of fatalities represent an incidence of 2.8, 2.3, 11.5, and 32.2 cases/100,000 patient years, respectively. "The possibility of myocarditis should be considered in patients receiving clozapine who present with unexplained fatigue, dyspnea, tachypnea, fever, chest pain, palpitations, other signs or symptoms of heart failure, or electrocardiographic findings such as ST-T wave abnormalities or arrhythmias. It is not known whether eosinophilia is a reliable predictor of myocarditis. Tachycardia, which has been associated with clozapine treatment, has also been noted as a presenting sign in patients with myocarditis. Therefore, tachycardia during the first month of therapy warrants close monitoring for other signs of myocarditis." The full text of the letter, dated February 2002, is available at http://www.fda.gov/medwatch/SAFETY/2002/Clozaril_deardoc.pdf This update is provided as a service to the movement disorder community, and does not constitute advice regarding use or discontinuance of use of this medication. ========================= Copyright 2002 WE MOVE Editor: Richard Robinson ([log in to unmask]) - Your E-MOVE news subscription is provided free of charge, courtesy of WE MOVE. PRIVATE DONATIONS ARE NEEDED TO SUPPORT WE MOVE's VALUABLE, FREE SERVICES LIKE THIS ELECTRONIC NEWS SERVICE. Donate online at http://www.wemove.org, or send your tax-deductible contribution to WE MOVE, 204 West 84th Street New York, NY 10024. TEL 800-437-MOV2 or 212- 875-8312. Thank you so much! - This document may be freely redistributed by email only in its unedited form. We encourage you to share it with your colleagues. Visit http://www.wemove.org/emove for E-MOVE archives and information on subscribing to E-MOVE. To unsubscribe, send an e-mail to [log in to unmask] with "unsubscribe" in the message body. - WE MOVE 204 West 84th Street New York, NY 10024 TEL 800-437-MOV2 TEL 212-875-8312 FAX 212-875-8389 ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn