FDA Issues Warning for IBS Drug Viberzi for Increased Risk of Pancreatitis

The FDA has issued a warning for Viberzi, which is used to treat irritable bowel syndrome (IBS) with diarrhea. The agency warns that this drug should not be used in patients who do not have a gallbladder as they have an increased risk of developing serious pancreatitis.

Viberzi is used to treat patients with IBS with the main symptom of diarrhea. The medicine decreases bowel contractions to reduce diarrhea in these patients and can help ease pain in the stomach or abdomen.

However, the FDA is reporting that hospitalizations and even deaths due to pancreatitis have been reported when Viberzi is used in patients who do not have a gallbladder. Symptoms of pancreatitis occur after just 1 or 2 doses of Viberzi at 75 mg, which is the recommended dosage for patients without a gallbladder who do not consume alcohol.

“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,” the FDA stated in its safety warning. “This pain may occur with nausea and vomiting.”

The FDA first approved Viberzi in May 2015 after 2 double-blind, placebo-controlled clinical trials with a total of 2425 patients showed the medicine was more effective in both reducing abdominal pain and improving stool consistency compared with the placebo. The drug is taken orally twice a day with food.

When it was approved, the FDA warned that Viberzi should not be used in patients with a history of pancreatitis.