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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<\/p>\n
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\u2019 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.<\/p>\n
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 \u201cA New Era in Clozapine Management,\u201d 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\u2019s advocacy.2<\/p>\n
\u201cEliminating the REMS for clozapine is more than a regulatory shift\u2014it 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\u2014they 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,\u201d 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\u2019s Adult Mental Health Division, told Psychiatric Times.<\/p>\n
\u201cNavigating 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,\u201d said Gordon Lavigne, the S&PAA chief executive officer.2<\/p>\n
\u201cA New Era in Clozapine Management\u201d will launch in the fall. This educational series will endeavor to meet several goals3:<\/p>\n
\u201cClozapine 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,\u201d said Michelle Geier, a psychiatric pharmacist and president of AAPP. \u201cThis 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.\u201d2<\/p>\n
The FDA first announced it did not \u201cexpect 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,\u201d back in February.4<\/p>\n
References<\/strong><\/p>\n 1. Clozapine REMS. Accessed June 16, 2025. https:\/\/www.newclozapinerems.com\/home<\/a><\/p>\n 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<\/a><\/p>\n 3. Provider training. Schizophrenia & Psychosis Action Alliance. Accessed June 16, 2025. https:\/\/sczaction.org\/provider-training\/<\/a><\/p>\n