FDA Officially Eliminates Clozapine REMS

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On June 13, 2025, the US Food and Drug Administration (FDA) officially eliminated the clozapine REMS, and all REMS operations ceased.¹

Although clozapine still carries a risk of severe neutropenia, the FDA has determined that the clozapine REMS is no longer necessary, and by eliminating the REMS, they expect to improve access to clozapine. Notably, the FDA still recommends monitoring patients’ ANC and information about severe neutropenia remains in the prescribing information for all clozapine medicines. From here on out, determination of the appropriateness of clozapine for a patient remains solely with the prescriber.

In the wake of this decision, the Schizophrenia & Psychosis Action Alliance (S&PAA), in collaboration with the American Association of Psychiatric Pharmacists (AAPP), has announced the upcoming development of “A New Era in Clozapine Management,” which is a set of clinical, evidence-based courses designed to provide education and guidance for clozapine prescribing. The revocation of bloodwork monitoring and other administrative requirements is a direct result of S&PAA’s advocacy.²

“Eliminating the REMS for clozapine is more than a regulatory shift—it is a moment of hope for patients and families who have waited too long for access to the most effective treatment for treatment-resistant schizophrenia. For too many, the barriers were not just clinical—they were also logistical. The new educational initiatives from S&PAA and AAPP are crucial to ensure this change reaches the patient. Without swift, practical guidance for prescribers, patients could still be left behind. We owe it to them to meet this moment with action,” said Chad Koyanagi, MD, a member of the S&PAA Board of Directors and medical director of the Crisis Continuum and Medicaid Services in the Hawaii Department of Health’s Adult Mental Health Division, told Psychiatric Times.

“Navigating treatment for schizophrenia is incredibly challenging. We are thrilled to launch our first in a series of educational programs to address and access effective care and treatment outcomes,” said Gordon Lavigne, the S&PAA chief executive officer.²

“A New Era in Clozapine Management” will launch in the fall. This educational series will endeavor to meet several goals³:

1. To help clinicians confidently and safely prescribe clozapine for treatment-resistant schizophrenia.
2. To provide training on initiation, monitoring, adverse effects management, special populations, and patient perspectives.
3. To blend clinical evidence with real-world strategies.
4. To reduce stigma and improve outcomes for people living with serious mental illness.

“Clozapine is a life-saving medication for those living with schizophrenia, but many clinicians have not received training on this medication nor managed and monitored patients on clozapine,” said Michelle Geier, a psychiatric pharmacist and president of AAPP. “This curriculum offering on clozapine is a huge step forward in ensuring that health care professionals have access to the information needed to save and improve patient lives.”²

The FDA first announced it did not “expect prescribers, pharmacies, and patients to participate in the risk evaluation and mitigation strategies (REMS) program for clozapine or to report results of absolute neutrophil count (ANC) blood tests before pharmacies dispense clozapine,” back in February.⁴

References

1. Clozapine REMS. Accessed June 16, 2025. https://www.newclozapinerems.com/home

2. S&PAA launches new education series to remove barriers to treatment & recovery. News release. June 16, 2025. https://www.einpresswire.com/article/822059272/s-paa-launches-new-education-series-to-remove-barriers-to-treatment-recovery

3. Provider training. Schizophrenia & Psychosis Action Alliance. Accessed June 16, 2025. https://sczaction.org/provider-training/

4. Duerr HA. FDA officially removes REMS requirement for clozapine. Psychiatric Times. February 25, 2025. https://www.psychiatrictimes.com/view/fda-officially-removes-rems-requirement-for-clozapine