Clozapine monitoring

Executive Summary

FDA's Psychopharmacologic Drugs Advisory Committee will meet June 16 to discuss the white blood cell monitoring schedule for patients on long-term clozapine (Novartis' Clozaril, generics) therapy. The committee will consider whether the frequency of monitoring can be decreased following "some period of bi-weekly monitoring." Labeling for the atypical antipsychotic recommends weekly monitoring for the first six months of continuous therapy and biweekly monitoring thereafter due to the risk of agranulocytosis. The meeting will be held June 16 at the Marriott Washingtonian Center in Gaithersburg, Md. beginning at 8 a.m. [To watch a live or archived 1webcast of this meeting, go to FDAAdvisoryCommittee.com. To arrange for live videoconferencing or to order videotapes and CDs, email [email protected] or call 800-332-1370 ext. 7210]....