Industry Briefs

FDA Modifies Clozapine Prescribing and Monitoring Requirements

This week, the Food and Drug Administration (FDA) announced that it is making changes to the requirements for monitoring, prescribing, and dispensing of clozapine. 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 taking the antipsychotic.

As part of the new changes, 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 clozapine registries maintained by individual clozapine manufacturers.

All prescribers and dispensers of clozapine must be certified in the Clozapine REMS Program in accordance with a specific transition schedule starting October 12.