In Brief: Pancreatitis with Eluxadoline (Viberzi) in Patients without a Gallbladder

Date: April 24, 2017 Issue #:  1519Summary:  The FDA has warned that eluxadoline (Viberzi– Allergan), a mu-opioid receptor agonist and delta-opioid receptor antagonist approved in 2015 for treatment of irritable bowel syndrome with diarrhea (IBS-D),1 should not be used in patients without a gallbladder because of an increased risk of serious pancreatitis.2As of February 2017, the FDA had received reports of 118 cases of serious, nonfatal pancreatitis and 2 deaths associated with use of eluxadoline. Both deaths occurred in patients without a gallbladder who developed severe abdominal pain and vomiting shortly after taking the first dose. At least 48 of the cases occurred after only 1 or 2 doses of eluxadoline. Of the 68 patients whose gallbladder status was reported, 56 did not have a gallbladder. Most of the patients without a gallbladder (44/56) were taking the reduced dosage of eluxadoline recommended for such patients (75 mg once/day).Patients considered at risk for pancreatitis were excluded from the two trials that led to approval of eluxadoline. One case of pancreatitis and 8 cases of abdominal pain with hepatic enzyme elevation associated with sphincter of Oddi spasm occurred with use of eluxadoline in the trials, all in patients without a gallbladder.3According to the current label, eluxadoline is contraindicated in patients who abuse alcohol (including those who consume>3 servings of alcohol per day) and in those with kn...
Source: The Medical Letter - Category: Drugs & Pharmacology Authors: Tags: Alosetron Diarrhea Drug Safety eluxadoline Imodium irritable bowel syndrome Loperamide Lotronex Rifaximin Viberzi Xifaxan Source Type: research