FDA Targets Antipsychotic Drug for Inducing Blood Disorder

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By Julie Fidler

The Food and Drug Administration is changing dispensing requirements for the drug clozapine, an atypical antipsychotic used to treat schizophrenia and schizoaffective disorder, and to treat suicidal behavior in individuals with the disorders.

To address “continuing safety concerns,” the FDA has “clarified and enhanced” prescribing information for clozapine to simplify how to monitor patients on the drug for a blood condition known as neutropenia and better manage treatment.

In doing so, the FDA approved a new, shared-risk evaluation and mitigation strategy (REMS), known as the Clozapine REMS Program.

According to MayoClinic.org, neutropenia is an abnormally low count of …read more

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