More than 100 people, most of whom did not have a gallbladder, who were treated with Viberzi, the new drug to treat irritable bowel syndrome with diarrhea (IBS-D), developed serious pancreatitis, 76 of whom were hospitalized and two of whom died, according to the Food and Drug Administration (FDA). As a result, the agency is advising doctors not to prescribe Viberzi to patients who do not have a gallbladder.
Pancreatitis is a painful inflammation of the pancreas. People who suffer from this condition may be at increased risk of developing pancreatic cancer.
“Pancreatitis may be caused by spasm of a certain digestive system muscle in the small intestine,” the FDA said in news release. “As a result, we are working with the Viberzi manufacturer, Allergan, to address these safety concerns.”
Viberzi was approved by the FDA in May 2015, and contains the active ingredient eluxadoline. It is used to treat irritable bowel syndrome in adults when the main symptom is diarrhea. IBS-D affects the large intestine and causes cramping, stomach-area or abdomen pain, bloating, gas, and diarrhea. The drug works by decreasing bowel contractions, which leads to less diarrhea.
Since the drug’s approval in May 2015, through February 2017, the FDA received 120 reports of serious pancreatitis or death. Among the 68 patients who reported whether they had a gallbladder, 56 reported they did not have a gallbladder and received the recommended dosage of Viberzi. Seventy-six of the 120 patients were hospitalized and two died. The two patients who died did not have a gallbladder.
Some patients who developed serious pancreatitis or death had abdominal pain or sphincter of Oddi spasm, a loss of normal function of the smooth muscle that surrounds the end portion of the common bile duct and pancreatic duct, which can cause obstruction of bile flow and obstruction to the flow of pancreatic juice into the intestine.
At the time of its approval, the most serious known risk with Viberzi was spasm in the sphincter of the Oddi. The drug’s safety label advises against giving the drug to patients with a history of bile duct obstruction, pancreatitis, severe liver impairment, or severe constipation, and in patients who drink more than three alcoholic beverages a day.
In the latest announcement, the FDA warned that symptoms of pancreatitis have occurred with just one or two doses of Viberzi at the recommended dosage for patients who do not have a gallbladder (75 mg), and who do not consume alcohol.
Anyone who has taken Viberzi and suffered from pancreatitis or other adverse events is advised to file a report with the FDA Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.