FDA Clarifies Prescribing Information for Antipsychotic Drug Clozapine

September 22, 2015

The FDA has clarified prescribing information for antipsychotic drug clozapine, explaining how to monitor and manage treatment of patients with neutropenia.

The clarification includes a new shared risk evaluation and mitigation strategy. The shared REMS, which replaces six existing clozapine registries maintained by individual manufacturers, requires prescribers, pharmacies and patients to enroll in a single centralized program, the agency says in a safety announcement issued last week.

Neutropenia will be monitored by the absolute neutrophil count only, rather than in conjunction with the white blood cell count.

Also, the requirements for ANC have been modified to allow patients to continue on clozapine treatment with a lower count. Patients with benign ethnic neutropenia who were not eligible for clozapine treatment will be able to receive the drug.

The revised prescribing information allows prescribers to make individualized treatment decisions if they determine the risk of psychiatric illness is greater than the risk of recurrent severe neutropenia, especially when clozapine may be the antipsychotic of last resort, the FDA says.

Clozapine was last associated with an FDA safety communication in 2011, when the agency updated the labeling of antipsychotic drugs to reflect potential risks of abnormal muscle movements and withdrawal symptoms in newborns. — Jonathon Shacat