Myocarditis and Cardiomyopathy Associated with Clozapine Use in the United States

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Abstract
We summarize cases of myocarditis and cardiomyopathy reported to the Food and Drug Administration (FDA) in patients treated with the atypical antipsychotic medication clozapine. Because it carries risks of agranulocytosis and seizures, clozapine is indicated for patients with severe schizophrenia who have no response to or who cannot tolerate standard antipsychotic agents. Between the U.S. approval of clozapine in September 1989 and December 2, 1999, the FDA received reports of 28 cases of myocarditis, including 18 deaths, and 41 cases of cardiomyopathy, including 10 deaths, that were temporally associated with the use of clozapine and that met at least one of the criteria described in Table 1 .1,2 Thirteen of the 18 deaths from myocarditis were confirmed at autopsy.

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