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  • FDA Eliminates Barrier to Clozapine, Plans to End REMS Program— Regular blood tests no longer required for prescription dispensing

    02/28/2025 9:43:31 AM PST · by sopo · 5 replies
    Medpage Today ^ | 02/26/2025 | Kristen Monaco
    FDA no longer expects prescribers, pharmacies, and patients to participate in the risk evaluation and mitigation strategy (REMS) program for the antipsychotic clozapine, Following the advice of a nearly unanimous joint FDA advisory committeeopens in a new tab or window, the agency decided that clozapine's REMS program is no longer necessary to ensure that the benefits of the drug outweigh the risk for severe neutropenia. The highly anticipated moveopens in a new tab or window will expand access to clozapine, which is the only drug indicated for treatment-resistant schizophrenia. It's also used in patients with recurrent suicidal behavior associated with...