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Controversy Grows Over Monitoring System for New Schizophrenia Drug

Matthew J. Kleinerman
JAMA. 1990;264(19):2488-2491. doi:10.1001/jama.1990.03450190018006.
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A RECENTLY introduced drug for schizophrenia is helping many patients who were previously considered untreatable. However, a potentially fatal side effect necessitates careful monitoring of patients. Just how this monitoring should be done is causing considerable controversy among the drug's manufacturer, patients, health care providers, and government officials.

The controversy has reached a pitch that suggests that the government may soon intervene in determining how patients who are taking this drug are to be monitored. The situation is this: An estimated 20% of patients who have schizophrenia do not respond to standard antipsychotic medications, and the drug, clozapine (Clozaril, Sandoz Pharmaceuticals Corp, East Hanover, NJ) has proved effective for many of them. Within 6 weeks of beginning treatment with clozapine, 30% of previously unresponsive patients show significant improvement, and another 30% improve within 6 months.

Thus, for many, clozapine makes hospital discharge a possibility that did not exist before. Clozapine


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