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FDA Modifies Clozapine Prescribing Information due to Neutropenia

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Washington, DC: Due to continuing safety concerns and current knowledge about a serious blood condition called severe neutropenia associated with the schizophrenia medicine clozapine, the U.S. Food and Drug Administration (FDA) is making changes to the requirements for monitoring, prescribing, dispensing, and receiving of the drug.

Treatment with clozapine may improve the symptoms of schizophrenia in patients who do not respond adequately to standard antipsychotic treatments. Symptoms of schizophrenia include hearing voices, seeing things that are not there, and being suspicious or withdrawn.

Severe neutropenia is a dangerously low number of neutrophils, white blood cells that help fight infections. Severe neutropenia can be life-threatening.



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