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FDA Updates Requirements for Clozapine in Light of Neutropenia Risk

Sep 16, 2015

The U.S. Food and Drug Administration (FDA) is changing certain safety requirements for clozapine, a medication used to treat patients with schizophrenia. According to a Drug Safety Communication issued on Sept. 15, the agency is modifying requirements for monitoring, prescribing, dispensing and receiving the drug "to address continuing safety concerns and current knowledge about a serious blood condition called severe neutropenia. Severe neutropenia is a dangerously low number of neutrophils, white blood cells that help fight infections. Severe neutropenia can be life-threatening".

The FDA is making two changes involving clozapine. The agency has "clarified and enhanced the prescribing information for clozapine that explains how to monitor patients for neutropenia and manage clozapine treatment." The FDA has also approved a new, shared risk evaluation and mitigation strategy (REMS) entitled the Clozapine REMS Program. These modifications will help in monitoring clozapine patients for neutropenia, the agency said. "The shared REMS is also expected to reduce the burden and possible confusion related to having separate registries for individual clozapine medicines".

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