Eluxadoline (Viberzi), a drug used to treat irritable bowel syndrome with diarrhea, should not be used in patients without gallbladders, the FDA warned on March 15. Clinicians should consider alternative treatment options for these patients, who have an increased risk of developing serious pancreatitis when taking the drug, according to an FDA safety announcement.
From May 2015, when eluxadoline was first approved, through February 2017, the agency received 120 such reports, according to a data summary. Seventy-six of these cases resulted in hospitalization, and two deaths were reported (one associated with pancreatitis, the other with sphincter of Oddi spasm). Serious pancreatitis or death has occurred in this patient population after only one or two doses. The FDA is working with the manufacturer to address these safety concerns.