Psychiatric News reports, “A panel convened by the Food and Drug Administration (FDA) voted overwhelmingly…against key provisions of the Clozapine Risk Evaluation and Mitigation Strategy (REMS) after hearing from clinicians, patients, and caregivers who said access to this effective schizophrenia medication was thwarted by red tape.” The FDA “panel voted 14-1 against the REMS requirement that prescribers document and pharmacies verify patients’ absolute neutrophil counts (ANC) before dispensing clozapine.” Additionally, the panel “voted 14-1 against the need for educating prescribers and pharmacists on the risk of clozapine-induced severe neutropenia and ANC monitoring.”
Related Links:
— “FDA Panel Votes 14-1 Against Clozapine REMS,” Psychiatric News, November20 , 2024