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FDA Addresses Neutropenia Risk With Clozapine

Agency revises product label

The FDA is making changes to the requirements for monitoring, prescribing, dispensing, and receiving the schizophrenia medicine clozapine, to address continuing safety concerns and current knowledge about severe neutropenia, which can be life-threatening.

There are two parts to the changes in the requirements for treating patients with clozapine. First, the FDA has clarified and enhanced the prescribing information for clozapine that explains how to monitor patients for neutropenia and how to manage clozapine treatment. Second, the agency has approved a new risk evaluation and mitigation strategy (REMS) program. The revised prescribing information and the clozapine REMS program will improve the monitoring and management of patients with severe neutropenia, according to the FDA. The REMS program is also expected to reduce the burden and possible confusion related to having separate registries for individual clozapine medicines. The requirements for monitoring, prescribing, dispensing, and receiving all clozapine medicines are now incorporated into the clozapine REMS program.

The program replaces the six existing clozapine registries maintained by individual clozapine manufacturers. It requires prescribers, pharmacies, and patients to enroll in a single centralized program. Patients who are currently treated with clozapine will be automatically transferred to the clozapine REMS program. To prescribe and dispense clozapine, prescribers and pharmacies will be required to be certified in the program according to a specific transition schedule starting on October 12, 2015.

The monitoring recommendations for neutropenia caused by clozapine treatment have also changed. Clozapine can decrease the number of neutrophils in the blood, in some cases causing severe neutropenia. As described in the revised clozapine prescribing information and in the clozapine REMS program, neutropenia will now be monitored only by the absolute neutrophil count (ANC) rather than in conjunction with the leukocyte count. Moreover, in the clozapine REMS program, the requirements for the ANC are 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. In addition, patients with benign ethnic neutropenia (BEN), who previously were not eligible for clozapine treatment, will now 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.

Source: FDA; September 15, 2015

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