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The side effects of clozapine make it one of the most challenging medications for psychiatrists to prescribe. The main factor that limits its use is the potential serious side effect of agranulocytosis. Agranulocytosis is defined as a drop in absolute neutrophil count (ANC) to levels below 500/mm3. In 1975, there were 17 cases of agranulocytosis in Finland, and widespread use of the medication for the treatment of schizophrenia was temporarily halted (Amsler et al. 1977; de la Chapelle et al. 1977). Agranulocytosis is a potentially lethal side effect that occurs in less than 1% of patients treated in the United States (Alvir et al. 1993). In the United States, all patients who are taking clozapine are entered into a national registry. Through the national registry, patients are prescribed the medication only if their WBC count shows no signs of clinically meaningful suppression (Honigfeld 1996). In a review of the morbidity and mortality of clozapine-treated patients (Honigfeld et al. 1998) over a 5-year period, 99,502 patients were registered through the Clozaril National Registry. Of these, 2,931 (2.95%) patients developed leukopenia (WBC count = 3,500/mm3), and 382 (0.38%) patients developed agranulocytosis (ANC <500/mm3). Twelve of the cases of agranulocytosis (0.012%) were fatal. These findings contrast with the 1%–2% cumulative incidence expected from the premarketing experience with clozapine. In the United States, 1,743 patients received the drug in premarketing trials. In addition, this estimate was based on trials in Europe performed in the 1970s and 1980s (Honigfeld et al. 1998). The encouraging report by Honigfeld et al. (1998) supports the monitoring system for clozapine as an adequate measure to prevent agranulocytosis.

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