In a recent U.S. Food and Drug Administration (FDA) Drug Safety Podcast for health care professionals, Lesley Navin, an advanced practice nurse from the Division of Drug Information, announced that FDA would be changing the requirements for the monitoring, prescribing, dispensing and receiving of the schizophrenia medicine Clozapine.
The changes were made in response to safety concerns and knowledge about a serious blood condition called severe neutropenia, defined as a dangerously low number of neutrophils, white blood cells that help fight infections.
"We previously communicated safety information associated with clozapine in February 2011," Navin said. "There are two parts to the changes. First, we clarified and enhanced the prescribing information for Clozapine that explains how to monitor patients for neutropenia and manage clozapine treatment. Second, we approved a new shared REMS called the Clozapine REMS (Risk Evaluation and Mitigation Strategy) Program. The requirements to monitor, prescribe, dispense, and receive clozapine are now incorporated into the Clozapine REMS Program."
This program, Navin said, replaces the six existing Clozapine registries maintained by individual Clozapine manufacturers and mandates that prescribers, pharmacies, and patients enroll in a single, centralized program.
Patients treated with Clozapine will be automatically transferred to the shared REMS. Prescribers and pharmacies will be required to be certified in the shared REMS according to a specific transition schedule starting Oct. 12.
For more information, visit www.fda.gov/DrugSafetyCommunications.
