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FDA Removes Risk Evaluation and Mitigation Strategies (REMS) Program for the Antipsychotic Drug Clozapine 

The U.S. Food and Drug Administration (FDA) removed the risk evaluation and mitigation strategy (REMS) for clozapine (currently marketed as Clozaril, Versacloz, and generics), effective June 13, 2025. Clozapine, an antipsychotic medicine, can cause severe neutropenia (a low level of certain white blood cells), which can lead to serious and fatal infections. The removed REMS required enrollment of prescribers, pharmacies, and patients in a restricted distribution program and reporting of the level of certain white blood cells (i.e., the absolute neutrophil count (ANC)) to mitigate the risk of severe neutropenia.  

Based on FDA’s re-evaluation of the Clozapine REMS and on the November 19, 2024 Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Psychopharmacologic Drugs Advisory Committee, the Agency determined that the REMS was no longer necessary to ensure the benefits of clozapine outweigh the risk of severe neutropenia. Although there remains a risk of severe neutropenia with clozapine use, clozapine labeling (including a new Medication Guide) is sufficient to mitigate this risk and maintain a positive benefit/risk profile. ANC monitoring can help identify neutropenia early to allow for timely intervention. Therefore, prescribers should continue to monitor patients’ ANC according to the monitoring frequencies described in the prescribing information. Eliminating the REMS is expected to improve access to clozapine and decrease the burden on the health care delivery system.  

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