The FDA Removal of the Clozapine REMS Requirement: An Expert Perspective

Psychiatric Times recently spoke with Chelsie Monroe, MSN, APN, PMHNP-BC, about the US Food and Drug Administration’s (FDA) decision to remove the Clozapine Risk Evaluation and Mitigation Strategy (REMS) requirement.^1,2 Monroe shared her insights on how this regulatory change will impact clinical practice and patient care.

According to Monroe, psychiatric nurse practitioner and founder of Balanced Mental Wellness, LLC, the removal of the REMS requirement is a significant step forward in reducing barriers to clozapine access. “The risks of neutropenia are actually much lower for individuals who have been on clozapine for years,” she explained, adding that these risks decrease drastically after the first 6 months of treatment. With the REMS requirement lifted, prescribers will no longer need to enter absolute neutrophil counts (ANCs) into the REMS system to dispense the medication, which Monroe sees as a major benefit for providers, patients, and pharmacies.

Despite this regulatory change, Monroe emphasized the continued importance of ANC monitoring. She recommends maintaining the current monitoring guidelines for the first 6 months of treatment and is looking to expert guidance for recommendations beyond that timeframe. Although the frequency of ANC checks is expected to decrease, Monroe anticipates new monitoring guidelines will be released soon to help clinicians navigate best practices moving forward.

Ultimately, Monroe sees this change as a positive step in improving access to clozapine for patients with treatment-resistant schizophrenia. “I don’t think patients will have to be forever looking at ANCs,” she noted, calling the FDA’s decision a significant advancement in schizophrenia care. She advised clinicians to stay informed as new guidelines emerge to ensure safe and effective prescribing in this evolving treatment landscape.

Ultimately, Monroe told Psychiatric Times this is good news and "represents another major step forward in the treatment of schizophrenia."

Do you have concerns or questions about what the FDA decision means for your patients? Do you have clinical pearls to share on this or other issues in psychiatry? Let us know at PTEditor@mmhgroup.com.

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References

1. Duerr HA. FDA Officially Removes REMS Requirement for Clozapine. Psychiatric Times. February 25, 2025. Accessed March 21, 2025. https://www.psychiatrictimes.com/view/fda-officially-removes-rems-requirement-for-clozapine

2. Weiden PJ, Duerr HA. Clozapine REMS and Other Barriers: A Conversation With Peter J. Weiden, MD. Psychiatric Times. November 30, 2025. Accessed March 21, 2025. https://www.psychiatrictimes.com/view/clozapine-rems-and-other-barriers-conversation-with-peter-weiden