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U.S. Department of Health and Human Services

Safety

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Clozaril (clozapine) February 2002

Audience: Psychiatrists, Pharmacists

FDA and Novartis have strengthened the BOXED WARNING and WARNINGS sections of the prescribing information (PI) for Clozaril (clozapine) as follows: (1) The previously existing BOXED WARNING has been relocated to the beginning of the PI and revised to advise health care providers of the association of myocarditis with clozapine therapy; (2) A subsection has been added to the WARNINGS section entitled "Myocarditis" to provide data and clozapine treatment guidelines related to this issue.

[Feb 20, 2002 - Letter - Novartis]