FDA modifies requirements for treating patients with schizophrenia drug

The Food and Drug Administration today announced changes to the requirements for monitoring, prescribing, dispensing and receiving the schizophrenia medicine clozapine to address continuing safety concerns about a serious blood condition called severe neutropenia. First, FDA revised the prescribing information for clozapine to further explain how to monitor patients for neutropenia and manage clozapine treatment. Second, FDA approved the Clozapine Risk Evaluation and Mitigation Strategy Program to replace six existing clozapine registries maintained by individual manufacturers. To prescribe and dispense clozapine, prescribers and pharmacies will be required to be certified in the new Clozapine REMS Program according to a specific transition schedule starting Oct.12. Patients currently treated with clozapine will be automatically transferred to the new program. FDA urged health care professionals and patients to report side effects involving clozapine medicines to the FDA MedWatch program.