In 2017, the FDA warned that Viberzi pancreatitis may be a side effect of treatment with the irritable bowel syndrome drug.

Viberzi was approved by the U.S. Food and Drug Administration (FDA) in May 2015 after being developed by Allergan as a treatment for irritable bowel syndrome (IBS) with diarrhea. The drug works by decreasing contractions in the bowel which helps to lessen diarrhea symptoms.

However, this mechanism may lead to Viberzi pancreatitis by triggering spasms in the sphincter of the Oddi. This is the valve that controls the flow of bile from the pancreas to the gallbladder and intestines. When this valve spasms, enzymes released by the pancreas can be activated before they reach the small intestines. Instead of these enzymes reportedly attack the pancreas, causing pancreatitis.

Pancreatitis is the inflammation of the pancreas due to a variety of problems. When the condition is mild, pancreatitis may resolve without treatment. However, severe cases of pancreatitis may be life-threatening. 

In March 2017, the FDA released a safety alert warning consumers and doctors that use of Viberzi in patients without a gallbladder may lead to life-threatening pancreatitis. Between the drug’s release and the end of February 2017, the FDA reportedly received 120 reports of pancreatitis in Viberzi patients – including two deaths.

Symptoms of Viberzi pancreatitis to watch for include upper abdominal pain, fever, rapid pulse, nausea, vomiting, abdominal tenderness, and, in chronic cases, weight loss.

Of the 68 affected patients who reported whether or not they had a gallbladder, 56 patients did not have a gallbladder when developing pancreatitis. 76 patients affected in the reported time period were hospitalized due to the condition, including the two patients who died. Of the two deaths, one was linked to pancreatitis and the other was linked to sphincter of Oddi spasm.

“Notably, the patient who experienced pancreatitis died within 3 days of taking the initial Viberzi dose,” the FDA reported.

The federal agency recommended that patients who have had their gallbladder removed for any reason should stop taking Viberzi under the supervision of a doctor. The FDA has also said that health professionals should not prescribe Viberzi to patients without a gallbladder moving forward.

The drug is also not recommended to users who consume more than three alcoholic beverages a day, have chronic constipation, experience digestive problems due to a sphincter of Oddi problem, or experience gallbladder obstruction, intestinal obstruction, liver disease, or pancreatic issues.

“For many people, eluxadoline (Viberzi) can positively improve how they go about their day-to-day activities,” David Nicholson, Allergan’s executive vice president of R&D, said to Healio.

“While adverse events are extremely rare, Allergan considers the safety of patients its priority and is in full agreement with the FDA that Viberzi should only be used in patients with a gallbladder, where it has been shown to be both safe and efficacious. This has been established in two phase 3 clinical studies comprising more than 2,400 patients. The updated Viberzi label reflects this new information, and we want to ensure that prescribers understand the full story around Viberzi.”