The FDA recently issued a warning regarding a correlation between Viberzi and pancreatitis in 2017, stating that patients without a gallbladder could be at serious risk for this complication. Vibezi patients have reportedly been hospitalized or died from pancreatitis, with symptoms setting in after just one or two 75 mg doses in non-alcoholic patients, according to the FDA.

Viberzi (eluxadoline) works by decreasing bowel movement contractions, which decreases the amount of diarrhea the patient experiences. This medication can also help ease stomach or abdominal pain as well as improve stool consistency, in patients with irritable bowel syndrome (IBS).

However, Viberzi’s treatment mechanism may cause spasms in the sphincter of Oddi, which is the valve that regulates the flow of bile between the gallbladder, pancreas, and the small intestine, according to Healio.

These spasms may cause digestive enzyme from the pancreas to be activated prematurely before reaching the small intestine, which can cause the enzyme to attack the pancreas directly.

Overview of Viberzi and Pancreatic Complications

Viberzi was approved in 2015 by the FDA to treat diarrhea from irritable bowel syndrome, with the FDA previously stating it was working with manufacturer Allergan to properly address the alleged link between Viberzi and pancreatitis.

The warning came at the end of February 2017, with the agency stating it had received 120 reports of pancreatitis, which reportedly included two deaths.

According to the warning, 56 out of 68 patients who reported their gallbladder status were without the organ and had started suffering adverse pancreatitis symptoms after taking the recommended 75 mg doses.

Out of these 68 patients, 21 of these patients did not drink alcohol while 35 did not specify if they drank. In addition, a sphincter of Oddi spasm was reported in six cases with abdominal pain being reported in 16 cases.

Overall, approximately 76 patients were hospitalized, with one of the patients who did not have a gallbladder allegedly dying from pancreatitis. The other Viberzi death was reportedly due to sphincter of Oddi spasm.

There were a total of 84 injury reports submitted from Viberzi patients who allegedly experienced pancreatic complications.

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

Dr. David Nicholson, executive vice president of research and development at Allergan, told Healio Gastroenterology that the company “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.”

However, the company also points out the Viberzi has been used by numerous patients who have not experienced such serious complications.

Pancreatitis is a life threatening condition in which the pancreas becomes inflamed, which can be caused when digestive enzymes become activated before reaching the small intestine.

Pancreatitis can either be chronic or acute, with the latter typically being quite sudden but most patients make a complete recovery with treatment. Chronic pancreatitis is long lasting inflammation, which typically occurs from an acute episode of this condition.

Given the severity of this condition, the FDA and the rest of the medical community is taking the alleged correlation between Viberzi and pancreatitis very seriously.