Removal of the REMS Requirement for Clozapine: Appropriate Monitoring Still Crucial

The US Food and Drug Administration recently decided that the clozapine REMS (Risk Evaluation and Mitigation Strategy) protocol was no longer necessary.¹ Gustavo Alva, MD, FAPA, the Mood Disorders Section Editor for Psychiatric Times, shares that despite this decision, it is still essential for clinicians to closely monitor their patients with schizophrenia when starting them on an antipsychotic.

COVID-19 made the REMS protocol especially challenging, shared Alva. "A lot of individuals were fearful of going into the lab and being around other people."

The FDA noted that all antipsychotics carry a warning to be on the lookout for a drop in white blood cell count, and therefore, the onerous REMS system was not necessary.

"To a degree, it's liberating, but we cannot forget or forego the fact that we do need to monitor our patients appropriately," concluded Alva.

Reference

1. Duerr HA. FDA officially removes REMS requirement for clozapine. Psychiatric Times. February 25, 2025. https://www.psychiatrictimes.com/view/fda-officially-removes-rems-requirement-for-clozapine