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Clozapine REMS A Barrier To Treatment And Unnecessary For Safe Use, US FDA Adcomms Say

 
• By Sue Sutter

The atypical antipsychotic’s Risk Evaluation and Mitigation Strategy should be retired because the requirements for prescriber education and documentation on absolute neutrophil count monitoring are hindering access, panelists said.

Many open public hearing speakers at the advisory committee meeting wore t-shirts attesting to clozapine's safety. (Sue Sutter)

The clozapine Risk Evaluation and Mitigation Strategy appears headed for elimination after two US Food and Drug Administration advisory committees voted that the program’s education and documentation requirements were not necessary for the antipsychotic’s safe use.

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