On March 15, 2017, the FDA warned 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. As a result, the FDA is working with the Viberzi manufacturer, Allergan, to address these safety concerns.
Pancreatitis is an inflammation of the pancreas, an organ important in digestion. Pancreatitis may be caused by a spasm of the sphincter of Oddi, a muscular valve in the small intestine that controls the flow of digestive juices to the gut.
Viberzi is a prescription medicine used to treat irritable bowel syndrome in adults when the main symptom is diarrhea (IBS-D). IBS-D affects the large intestine and causes cramping, stomach-area or abdomen pain, bloating, gas, and diarrhea. The cause of IBS-D is not known. Viberzi works by decreasing bowel contractions, which leads to less diarrhea. In patients with IBS-D, Viberzi can help ease stomach-area or abdomen pain and improve stool consistency.
Health care professionals should not prescribe Viberzi in patients who do not have a gallbladder and should consider alternative treatment options in these patients. Hospitalizations and deaths due to pancreatitis have been reported with Viberzi use in patients who do not have a gallbladder. 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.
Patients who do not have a gallbladder should stop taking Viberzi right away and get emergency medical care if they develop new or worsening stomach-area or abdomen pain, or pain in the upper right side of the stomach-area or abdomen that may move to the back or shoulder. This pain may occur with nausea and vomiting. These may be symptoms of pancreatitis or a spasm of the sphincter of Oddi.
See the FDA Safety Alert
See the FDA Safety Communication
See also Medical Law Perspectives, December 2016 Report: Gut-Wrenching Pain: Liability Risks Related to Gastrointestinal Disorders
See also Medical Law Perspectives, July 2015 Report: Organ Transplants: Saving Lives, Facing Risks, Minimizing Complications
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See the Medical Law Perspectives February 23, 2017, Blog: Laparoscopic Gallbladder Removal: Minimally Invasive Procedure with Significant Risks