Novartis and FDA Notifies Doctors and Patients to Revisions to the Boxed Warnings for Clozaril Tablets.

The Food and Drug Administration (FDA) released the following information:

Novartis and FDA notified healthcare professionals of revisions to the boxed warning, contraindications, precautions (information for patients and pharmacokinetic-related interactions subsections), and adverse reactions (Postmarketing Clinical Experience subsection) sections of the prescribing information for Clozaril (clozapine) tablets. Recommendations from the FDA's Psychopharmacological Drugs Advisory Committee regarding the white blood cell monitoring schedule, required for all clozapine users, has resulted in modification in the monitoring schedule. Additional labeling changes address safety issues related to dementia-related psychosis, parlytic ileus, hypercholesterolemia and pharmacokinetic interaction with citalopram.