Side effects of Viberzi, a drug that treats irritable bowel syndrome, may include life-threatening pancreatitis in patients who have had their gallbladder removed.

Irritable bowel syndrome with diarrhea (IBS-D) is a digestive system condition that can cause diarrhea, abdominal pain, and other symptoms. There are several different sets of criteria for IBS diagnosis and a doctor may need to run a series of tests to rule out other conditions including inflammatory bowel disease (IBD), celiac disease, and colon cancer.

IBS-D is often treated with dietary changes and over the counter medications, but some doctors may choose to prescribe medication to manage the condition.

Viberzi (eluxadoline) is a medication that may be prescribed to treat IBS-D. This drug relieves diarrhea symptoms by easing the muscle contractions and fluid secretion in the intestines. Although this mechanism helps to reduce diarrhea symptoms, it may lead to life threatening complications.

In March 2017, the U.S. Food and Drug Administration (FDA) announced that Viberzi patients who have had their gallbladder removed may end up with pancreatitis. The potentially life-threatening condition is reportedly caused by a spasm of the sphincter of Oddi, a bile duct that controls the flow of digestive enzymes from the bile glands to the small intestines.

When the sphincter of Oddi spasms, it reportedly activates the digestive enzymes in bile that then attack the pancreas and cause pancreatitis.

Pancreatitis is the inflammation of the pancreas, a long flat bile gland in the upper abdomen that helps with digestion and the processing of sugars. Pancreatitis can be acute, appearing suddenly and lasting for days, or it can be chronic, occurring over many years.

Symptoms of acute pancreatitis may include abdominal pain, fever, rapid pulse, nausea, vomiting, and abdominal tenderness. Symptoms of chronic pancreatitis may include upper abdominal pain, unexplained weight loss, and oily, smelly stools.

Although pancreatitis may be effectively treated, failure to treat the problem can be extremely threatening – resulting in hospitalization or death.

According to the FDA’s safety announcement, 120 cases of Viberzi pancreatitis have been reported to the agency since the drug’s approval in May 2015. 76 of these patients were hospitalized. Of the 68 patients who reported their gallbladder status to the FDA, 56 patients had previously had their gallbladder removed.

This trend has lead the FDA to theorize that the lack of a gallbladder may contribute to the pancreatic side effects of Viberzi. Unfortunately, two of the hospitalized patients died in connection with their pancreatitis.

The FDA encourages patients to be vigilant about potential symptoms of pancreatitis while taking Viberzi, especially if they have had their gallbladder removed.

“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,” the FDA instructs.

Pancreatic side effects of Viberzi may show up after only one or two doses of the recommended 75 mg dose, if a patient does not have their gallbladder and doesn’t drink alcohol.