FDA Requires Revised REMS for Clozapine

The FDA has revised the Risk and Evaluation and Mitigation Strategy (REMS) for the generic anti-psychotic drug clozapine in an effort to improve patient monitoring for the rare blood disorder neutropenia.

Clozapine is used to treat schizophrenia and can reduce the risk of suicide in patients suffering from either schizophrenia or schizoaffective disorder.

The revised REMS, which will go into effect on Nov. 15, will require prescribers and pharmacies to re-certify in the program. It mandates that prescribers submit new patient status forms to document their white blood cell counts, while continuing the patient monitoring required in the drug’s prescribing information.