FDA Drug Safety Communication: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder

FDA is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasm of a certain digestive system muscle in the small intestine. Patients should talk to your health care professional about how to control your symptoms of irritable bowel syndrome with diarrhea (IBS-D), particularly if you do not have a gallbladder. Stop taking Viberzi right away and get emergency medical care if you develop new or worsening stomach-area or abdomen pain, or pain in the upper right side of your stomach-area or abdomen that may move to your back or shoulder, with or without nausea and vomiting. These may be symptoms of pancreatitis, an inflammation of the pancreas which is an organ that is important in digestion, or spasm of the sphincter of Oddi which is a muscular valve in the first part of the small intestine controlling the flow of digestive juices to the gut. Symptoms of pancreatitis have occurred with just one or two doses of Viberzi at the recommended dosage for patients who do not have a gallbladder (75 mg), and who do not consume alcohol.
Source: FDA Center for Drug Evaluation and Research - What's New - Category: Drugs & Pharmacology Source Type: news