With the development of medications used to treat irritable bowel syndrome, patients considering their options want to know what the side effects of Viberzi are. Viberzi, also known generically as eluxadoline, was approved by the U.S. Food and Drug Administration (FDA) in late May of 2015, according to Drugs.com.

The Mayo Clinic website lists other medications for this elusive condition as Lotronex, Xifaxan, Amitiza,  and Linzess—known generically as alosetron, rifaximin, lubiprostone, and linaclotide, respectively. Viberzi has specifically come into the spotlight, however, with the recent release of a safety alert communication concerning the drug from the FDA.

The FDA Announcement Concerning Side Effects of Viberzi

Published in March 2017, nearly two years after the IBS drug’s approval by the same oversight agency, the FDA send out an alert to consumers and medical professionals which drew attention to alarming side effects of Viberzi. The alert focused on the risk of pancreatitis in consumers whose gallbladder has been removed.

The Sphincter of Oddi

Specifically mentioned in the alert was the sphincter of Oddi, a valve located in the small intestine that allows for or reduces the flow of important digestive juices to this area.

Spasms in the sphincter of Oddi and pancreatitis—inflammation of an extremely important digestive organ—can produce serious symptoms which need to be immediately addressed to avoid potentially deadly consequences.

One of these significant symptoms is a severely upset stomach with vomiting that worsens over time. This pain can usually be isolated to the upper right side of the stomach area, according to the FDA. The pain can refer to mid-back and shoulder area and heralds the need for a quick response.

The FDA identifies potential concurrent symptoms as unexplained fever and sweating, and severe reduction in appetite with weight loss. Patients without gallbladders should seek medical care without delay and may consider stopping Viberzi.

The FDA safety alert was based upon 120 reported cases of pancreatitis in Viberzi consumers over its two-year approval period. The pancreatitis events were identified in patients having issues with or being treated for gallbladder issues. Of the 120 cases, nearly half had had their gallbladders removed.

Seventy-six patients were admitted to the hospital for their pancreatitis. Two Viberzi patients of this group—both without gallbladders—succumbed to the dangerous condition.

What Happens With Viberzi-induced Pancreatitis?

According to Very Well Health, the sphincter of Oddi may spasm under the influence of Viberzi and allow digestive enzymes to be released from the pancreas and become activated outside of the small intestine. These enzymes then in turn start to break down the pancreas itself, leading to gross inflammation and eventual death.

While these sphincter spasms may not be the total causation of this side effect of Viberzi, consumers need to be aware and avoid this treatment modality if they have had an obstruction or removal of the gallbladder. If there has been a personal history of digestive issues related to proper functioning of the sphincter, it should also not be considered a viable choice.

Other related situations which should give pause would be a high intake of alcohol—more than three drinks per day, liver disease, intestinal obstruction of any kind, and previous pancreatic issues.