FDA: Schizophrenia Drug Associated with Serious Blood Condition

By Kristin J. Kelley

Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM

In light of continuing concerns regarding the schizophrenia drug clozapine and its severe neutropenia risk, the FDA has changed the drug's prescribing information. Additionally, starting next month, clozapine will only be able to be prescribed and dispensed through a single risk evaluation and mitigation strategy (REMS) program.

The new label clarifies that patients on clozapine should be monitored for severe neutropenia by checking the absolute neutrophil count in the blood. Previously, patients' white blood cell counts were also monitored. In addition, patients will be allowed to stay on clozapine with a lower absolute neutrophil count.

In 2011, the FDA warned against antipsychotic use (including clozapine) and risks for both abnormal muscle movements and withdrawal symptoms in newborns when the drugs are used during pregnancy.