Based on an FDA update published in February with little fanfare, the risk evaluation and mitigation strategies (REMS) program for clozapine products has ended effective Feb. 24, 2025. Prescribers, pharmacies, and patients are no longer required to participate in the REMS program for clozapine and pharmacies no longer need the results of absolute neutrophil count (ANC) blood tests before dispensing clozapine. FDA still recommends that prescribers monitor patients’ ANC according to the monitoring frequencies described in the prescribing information.
FDA is working with the clozapine manufacturers to update the prescribing information and eliminate the Clozapine REMS. Please email [email protected] if there are problems with getting claims paid for clozapine due to the end of the REMS program.
