MedPage Today (6/17, Monaco ) reports the FDA has “eliminated clozapine’s risk evaluation and mitigation strategy (REMS) program, with all REMS operations stopped as of June 13.” The announcement comes months after “joint FDA advisory committee voted to eliminate the REMS program for clozapine that was put in place due to the risk for severe neutropenia associated with the drug, which is used to treat schizophrenia and schizoaffective disorder.” With the program eliminated, “clozapine prescribers don’t need to submit patients’ absolute neutrophil count (ANC) results and pharmacies no longer need to obtain a REMS Dispense Authorization prior to dispensing clozapine.” The FDA continues to recommend “that prescribers monitor patients’ ANC according to the monitoring frequencies listed on the drug label.”
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