FDA/CDC

FDA: Clozapine REMS modified


 

The Food and Drug Administration has modified the Risk Evaluation and Mitigation Strategy (REMS) Program for clozapine, a second-generation antipsychotic used for patients who do not respond adequately to standard antipsychotic treatment. Use of clozapine comes with the risk of neutropenia, which can make patients vulnerable to serious infections, so routine monitoring of absolute neutrophil counts is a must.

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The new requirements, including one that requires both prescribers and pharmacies to be certified in the clozapine REMS program, take effect Feb. 28.

More information about clozapine and this change can be found on the FDA web page for the drug.

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