Monday, November 22, 2021

FDA Temporarily Suspends Some Clozapine REMS Program Requirements

The Food and Drug Administration (FDA) has temporarily suspended certain requirements of the recently modified Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program after the agency received reports of challenges with the program. The Clozapine REMS is a safety program required by the FDA to manage patients’ risk of neutropenia associated with clozapine treatment.

“Health care professionals continue to alert FDA about ongoing difficulties with the Clozapine REMS program, including a high call volume and long call wait times for stakeholders since launch of the program on November 15,” the FDA wrote in a statement. “We understand that this has caused frustration and has led to patient access issues for clozapine. … Continuity of care, patient access to clozapine, and patient safety are our highest priorities. We are working closely with the Clozapine REMS program administrators to address these challenges and avoid interruptions in patient care.”

The temporary changes mean that pharmacists may dispense clozapine without REMS dispense authorization and wholesalers may continue to ship clozapine to pharmacies and health care settings without confirming REMS enrollment.

Patients who abruptly stop using clozapine can experience significant physical and behavioral symptoms, including the potential re-emergence of psychosis.

If you are having problems with the Clozapine REMS, please contact the APA Practice Helpline or SMI Adviser.

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