Safety Alerts for Human Medical Products > Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder

Safety Alerts for Human Medical Products > Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder

U.S. Food and Drug Administration (FDA) Advisory

March 15, 2017: Viberzi (eluxadoline): FDA is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasm of a certain digestive system muscle in the small intestine. As a result, FDA is working with the Viberzi manufacturer, Allergan, to address these safety concernsars.