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# FDA Safety Alert on Allergan’s Viberzi
- URL: https://www.fdaweb.com/fda-safety-alert-on-allergans-viberzi/
- Published: 2017-03-15T12:00:00.000Z
- Updated: 2026-09-14T22:11:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138211

An FDA drug [safety alert](https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm546771.htm?ref=fdaweb.com) warned 3/15 that Allergan’s Viberzi (eluxadoline), a therapy used to treat irritable bowel syndrome with diarrhea, should not be used in patients who do not have a gallbladder. An agency review concluded these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. “From May 2015, when Viberzi was first approved, through February 2017, FDA received 120 reports of serious cases of pancreatitis or death,” the alert says. “Among the 68 patients who reported their gallbladder status, 56 of them did not have a gallbladder and received the currently recommended dosage of Viberzi. Seventy-six patients were hospitalized, of which two patients died. These two patients did not have a gallbladder.” FDA adds that it is working with Allergan to address the safety concerns.