FDA warns on safety on IBS-D drug Viberzi in certain patients
The US Food and Drug Administration is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder.
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 agency says it is working with Viberzi’s manufacturer, Ireland-incorporated Allergan (NYSE: AGN), to address these safety concerns.
The drug, which was launched in the USA in December 2015, is co-promoted with Ironwood Pharmaceuticals (Nasdaq: IRWD).
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