FDA Requires Closer Watch On Clozapine Patients For Neutropenia Blood Disorder
(September 16, 2015, 10:41 AM EDT) -- SILVER SPRING, Md. — The Food and Drug Administration on Sept. 16 said it is requiring closer monitoring of patients taking the atypical antipsychotic drug clozapine (brand name Clozaril) due to safety concerns about neutropenia, a disorder in which the white blood cells become dangerously low and that can become life-threatening.
The FDA said it has clarified and enhanced the prescribing information to explain how to monitor patients for neutropenia. In addition, the agency said it approved a new risk evaluation and mitigation strategy (REMS) to...