FDA addresses concerns regarding clozapine, severe neutropenia

The FDA is altering requirements for monitoring, prescribing, dispensing and receiving clozapine to address continued safety concerns about severe neutropenia.

The FDA has clarified and enhanced the prescribing information for clozapine to explain how to monitor patients for neutropenia and manage clozapine treatment.

Additionally, the administration has approved a new, shared risk evaluation and mitigation strategy (REMS) called the Clozapine REMS Program.

Together, the two actions will improve monitoring and management of patients with severe neutropenia.

The Clozapine REMS Program is expected to reduce the burden and potential confusion caused by having separate registries for individual clozapine medicines.

Patients currently treated with clozapine will be automatically transferred to the Clozapine REMS program, according to the FDA.

In order to prescribe and dispense clozapine, prescribers and pharmacies will be required to be certified in the Clozapine REMS Program following a specific transition scheduled starting Oct. 12, 2015. – by Amanda Oldt

For more information:

Visit http://www.fda.gov.