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FDA Modifies Clozapine Prescribing and Monitoring Requirements

Yesterday, the Food and Drug Administration announced that it is making changes to the requirements for monitoring, prescribing, and dispensing clozapine, a medication intended to treat symptoms of schizophrenia and recurrent suicidal behavior in patients with schizophrenia and schizoaffective disorder. The modifications are part of an effort to address continuing safety concerns over the increased risk of neutropenia—a serious blood condition characterized by dangerously low numbers of neutrophils (white blood cells that help fight infections)—in patients being treated with clozapine.As part of the new changes, the FDA has clarified and...

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Published By: Psychiatric News - 2 days ago