FDA Drug Safety Communication issued for clozapine; Health risks for schizophrenia medicine reevaluated

Ongoing concerns over the safety of schizophrenia drug clozapine have forced the Food and Drug Administration (FDA) to revise guidelines for prescribing, dispensing, monitoring, and receiving the drug. Clozapine is known to cause neutropenia, a serious medical condition where the body is unable to produce enough white blood cells to fight infections.

Clozapine is an atypical treatment for schizophrenia. Clozapine is also prescribed for off label treatments of bipolar disorder and borderline personality disorder. Clozapine was first developed in 1971 and approved as a schizophrenia treatment by the FDA in 1989. Since its approval, the prescription of clozapine has always required monitoring the patient’s white blood cell and absolute neutrophil count (ANC).

Two revisions were made to the guidelines for treating patients with clozapine. The first is clarification to and enhancing the prescribing information for clozapine as it pertains to managing the patient’s clozapine treatment and monitoring for symptoms of neutropenia.

The second revision consolidates six clozapine registries maintained by clozapine manufacturers into the Clozapine REMS Program. The REMS Program is a single registry that will serve as the standard for clozapine safety and treatment guidelines. The REMS requires doctors, pharmacies and patients to sign up for the centralized registry in order to be allowed to prescribe, dispense, and consume clozapine.

As part of the revised prescribing information and Clozapine REMS Program, symptoms of neutropenia will be tracked by observing the patient’s absolute neutrophil count (ANC). Symptoms of neutropenia were previously monitored via the ANC in conjunction with checking the patient’s white blood cell count. Patients with lower ANC will now be allowed to continue their clozapine treatment. Patients with benign ethnic neutropenia (BEN) will now be allowed to receive clozapine treatment where they previously were not.

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