FDA Approves Modification to Clozapine REMS Program

The U.S. Food and Drug Administration (FDA) approved a modification to the Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program. As a result of this modification, on February 28, 2019 a series of requirements will go into effect. Of note, is a requirement for health care professionals prescribing clozapine, as well as pharmacies dispensing clozapine, to be certified in the clozapine REMS program.

Clozapine is an antipsychotic drug used to help improve the symptoms of schizophrenia in patients who do not respond adequately to standard antipsychotic treatment.  While clozapine is beneficial for some patients, there are risks associated with this drug. Specifically, clozapine can decrease the number of neutrophils, a type of white blood cell, that function in the body to fight off infections. When neutrophils are significantly decreased, severe neutropenia may result, which can lead to serious infections and death. For this reason, patients taking clozapine need to have their absolute neutrophil count (ANC) monitored on a regular basis. This monitoring requirement serves as the basis for the Clozapine Risk Evaluation and Mitigation Strategy (REMS).

For more information on the changes to the clozapine REMS program that will take effect on February 28, 2019 see the updated CDER Statement and the Clozapine Product Manufacturers’ Group (CPMG) website.

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