Clozapine Dispensing Requirements Changed

The FDA is changing dispensing requirements for the schizophrenia drug clozapine (Clozaril) to address safety concerns about severe neutropenia. The first change involves new prescribing information that clarifies how health care professionals should manage clozapine treatment and monitor patients for neutropenia.

Now, neutropenia will be monitored only by the absolute neutrophil count (ANC), rather than in conjunction with the white blood cell count. Moreover, patients will be able to continue taking clozapine with a lower ANC, and those with benign ethnic neutropenia who previously were not eligible for clozapine will now be able to receive it.

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