FDA lifts risk evaluation and mitigation strategy reporting requirements for Clozapine

At a glance:

• The Food and Drug Administration (FDA) removed Clozapine from the risk evaluation and mitigation strategy (REMS) program, enhancing access while maintaining monitoring through label-recommended white blood cell (WBC) and absolute neutrophil count (ANC) checks.
• New studies show a low neutropenia risk for Clozapine.
• REMS removal aims to enhance Clozapine access and address treatment disparities, emphasizing patient-centered care.

We encourage you to integrate updated Clozapine guidelines into your practice, enhancing access for your patients while responsibly managing associated risks. Prioritize ongoing education about monitoring practices and ensure efficient collaboration with laboratory services to deliver optimal patient care.

Background

As of February 24, 2025, the FDA no longer requires adherence to the REMS program for Clozapine. Although warnings about agranulocytosis remain on the drug’s label and prescribers are still encouraged to monitor WBC and ANC, participation in the REMS program is no longer mandatory. The FDA is currently working with manufacturers to update the prescribing information.¹

The decision to discontinue the REMS program for Clozapine was a result of a November 2024 committee meeting, where 14 of 15 experts recommended its removal. This recommendation was based on recent studies from Finland, Australia, and New Zealand showing that the risk of neutropenia is rare and decreases significantly after six months, suggesting less monitoring is needed.^1,2,3,4

Role of Clozapine in schizophrenia treatment

Clozapine remains the only FDA‑approved medication for patients with treatment‑resistant schizophrenia who do not respond to standard treatments. Due to risks such as agranulocytosis and seizures, it should be prescribed only after other treatments have failed.⁵

Impact on prescribers, pharmacies, and patient accessibility

The removal of REMS is expected to make it easier for prescribers and pharmacies to offer Clozapine. However, continued education on managing side effects and improving access to lab testing is crucial for increasing patient access.

This change could also reduce treatment disparities, particularly for patients of African descent who may have genetic variations leading to lower ANC counts. Removing the REMS program for Clozapine does not lessen the need for careful, patient‑centered care. Care providers should focus on expanding access and offering patient support to ensure the best outcomes.

Thank you for your commitment to advancing patient care and staying informed on the latest developments. Together, we can continue to make a meaningful impact in the lives of our members — your patients.