FDA Strengthens Constipation Warning on Clozapine

By Amy Orciari Herman

Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM

The FDA is strengthening the warning about constipation associated with the schizophrenia drug clozapine (marketed as Clozaril, Fazaclo ODT, Versacloz). The agency says that, in rare cases, clozapine-associated constipation can lead to serious bowel problems which can, in turn, lead to hospitalization and death.

A review of adverse events reported to the FDA from 2006 to 2016 identified 10 such cases. Four patients developed necrotizing colitis; five, intestinal ischemia or necrosis; and one, volvulus. Five of these patients died.

The FDA offers numerous recommendations for clinicians. See the first link below for details.