Wednesday, September 16, 2015

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 enhanced the prescribing information for clozapine that explains how to monitor patients for neutropenia and manage clozapine treatment. In addition, the agency announced a new, shared risk evaluation and mitigation strategy (REMS) called the Clozapine REMS Program to improve the monitoring and management of patients with severe neutropenia. This program, which will require prescribers, pharmacies, and patients to enroll in a single centralized program, replaces the six existing clozapine registries maintained by individual clozapine manufacturers.

Neutropenia will now be monitored by the absolute neutrophil count (ANC) only, rather than in conjunction with the white blood cell count. The requirements for ANC are also being modified so that patients will be able to continue on clozapine treatment with a lower ANC—a change that will allow continued treatment for a greater number of patients. Patients with benign ethnic neutropenia, who previously were not eligible for clozapine treatment, will now also be able to receive the medicine.

“The revised prescribing information facilitates prescribers’ ability to make individualized treatment decisions if they determine that the risk of psychiatric illness is greater than the risk of recurrent severe neutropenia, especially in patients for whom clozapine may be the antipsychotic of last resort,” the FDA noted in a statement announcing the changes.

Patients who are currently treated with clozapine will be automatically transferred to the Clozapine REMS Program. In order to prescribe and dispense clozapine, prescribers and pharmacies will be required to be certified in the Clozapine REMS Program according to a specific transition schedule starting October 12, 2015.

For related information, see the Psychiatric News article “Why Won't Clinicians Use Clozapine Despite Proven Superiority?


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