The Food and Drug Administration (FDA) is warning patients and healthcare professionals that Viberzi (eluxadoline; Allergan) tablets should not be used in patients without a gallbladder due to an increased risk of developing serious pancreatitis that could lead to hospitalization or death.
Viberzi, a mu-opioid receptor agonist, is approved to treat irritable bowel syndrome with diarrhea (IBS-D). Since its approval in May 2015 through February 2017, the FDA has received 120 reports of serious cases of pancreatitis or death. Of the 68 patients who provided gallbladder status, 56 did not have one and had received the recommended dose of Viberzi. There were also 76 patients who were hospitalized of which 2 patients died; these 2 patients were without a gallbladder. Other cases of serious pancreatitis or death also had 6 reports of sphincter of Oddi spasm and 16 reports of abdomen pain.
Healthcare professionals should consider alternative treatment options in patients without a gallbladder as hospitalizations and deaths due to pancreatitis have occurred with Viberzi use in these patients. Symptoms of pancreatitis have been reported after just 1 or 2 doses of Viberzi at the recommended dosage (75mg) in patients who do not have a gallbladder, and who do not drink alcohol.
Viberzi should not be used in the following patients:
- Who do not have a gallbladder
- Have or may have had a blockage of the gallbladder or a sphincter of Oddi problem
- Have had pancreatitis or other pancreas problems, including a blockage of the pancreas
- History of serious liver problems
- History of chronic or severe constipation
- Have or may have had intestinal obstruction
- History of alcohol abuse, alcohol addiction, or drinks more than three alcoholic beverages a day
Over-the-counter (OTC) or other FDA-approved medications can be considered to treat symptoms associated with IBS-D such as bismuth subsalicylate (Kaopectate and Pepto-Bismol), loperamide (Imodium), and diphenoxylate/atropine (Lomotil) for diarrhea, and simethicone (Gas-X and Mylicon) for gas relief. Alosetron HCl (Lotronex) and rifaximin (Xifaxan) are other approved prescription drugs for IBS-D.
Viberzi, a CIV controlled substance, is available as 75mg and 100mg strength tablets in 60-count bottles.
For more information call (800) 433-8871 or visit FDA.gov.