The impact of clozapine on 25 forensic patients.

Clozapine was approved by the Food and Drug Administration (FDA) in October of 1989 for use through the Clozaril Patient Management System (CPMS). Prior to that date clozapine was prescribed on a "compassionate use" basis at 16 study centers in the U.S. It was used primarily with patients with a diagnosis of schizophrenia and schizoaffective disorder whose symptoms were refractory to traditional neuroleptics, or patients who had serious side effects to traditional neuroleptics, like tardive dyskinesia.', * Because clozapine can cause agranulocytosis in one to two percent of patients, the FDA approved the release of the drug through a controlled program that ensured close monitoring of the WBC and differential. The CPMS became the first company to establish a national monitoring system for a new drug3-' A review of European6 and American'-lo studies on clozapine demonstrated that clozapine outperformed other neuroleptics. One-third to one-half of patients who did not respond to traditional neuroleptics, did respond to clo-