The Food and Drug Administration has issued a safety alert warning of the increased risk of pancreatitis in patients taking the irritable-bowel syndrome (IBS) drug Verbizi (eluxadoline).
Verbizi is most often prescribed for IBS with diarrhea in both men and women. The drug is relatively new with FDA approval occurring in May 2015.
The FDA warned that the drug should not be taken by patients who do not have a gallbladder. The FDA warning states that an FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasm of a certain digestive system muscle in the small intestine. As a result, the FDA advises that they are working with the Viberzi manufacturer, Allergan, to address the safety concerns.
The FDA advised Health care professionals to not prescribe Viberzi in patients who do not have a gallbladder and should consider alternative treatment options in these patients.
The FDA further advised that hospitalizations and deaths due to pancreatitis have been reported with Viberzi use in patients who do not have a gallbladder.
Pancreatitis is the inflammation of the pancreas. The pancreas helps to regulate how the body processes sugar.
Mild cases of pancreatitis can resolve without medical intervention, however severe bouts of pancreatitis can be life-threatening. Learn more about pancreatitis here.
See the full FDA alert here.