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Eluxadoline (Viberzi®) may cause serious, life-threatening pancreatitis in patients without a gallbladder. Eluxadoline (Viberzi®) is a prescription product labeled for irritable bowel syndrome with diarrhea (IBS-D). Since its approval in May 2015, FDA has received 120 reports of pancreatitis or death associated with eluxadoline. Seventy-six of these patients were hospitalized and 2 patients died. Of the 120 patients, 68 reported their gallbladder status and 56 of these patients had no gallbladder. Both of the deaths were in patients without a gallbladder. Some of the pancreatitis cases occurred following just 1 dose of eluxadoline 75 mg (the recommended dose) and in patients not using ethanol. The manufacturer (Allergan) is working with FDA to address this safety concern with eluxadoline.
FDA asks that health care providers not prescribe eluxadoline to patients without a gallbladder, and consider other treatment options. Other treatment options for IBS-D include over-the-counter loperamide and bismuth subsalicylate. Prescription products used for IBS-D include alosetron (Lotronex®), diphenoxylate/atropine (Lomotil®), and rifaximin (Xifaxan®). Monitor patients using eluxadoline for signs and symptoms of pancreatitis, such as stomach pain that is new or worsening, stomach pain in the upper right side that radiates to the shoulder or back, nausea, and vomiting. If such symptoms occur, instruct patients to seek emergency medical help immediately. Review the medication guide that comes with eluxadoline with patients to discuss the risks of eluxadoline, including pancreatitis. Report events of pancreatitis to the FDA MedWatch Reporting Program.
Additional information is available at the following links:
- FDA Drug Safety Communication – March 15, 2017
www.fda.gov/Drugs/DrugSafety/ucm546154.htm - MedWatch – March 15, 2017
www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm546771.htm