FDA Issues Warning for Eluxadoline

The FDA has issued a warning about eluxadoline (Viberzi), a drug used to treat irritable bowel syndrome (IBS) with diarrhea. Use of the drug in patients without a gallbladder increases their risk of severe pancreatitis that could require hospitalization or result in death.

Symptoms of pancreatitis have occurred in these patients after as few as one or two doses of eluxadoline at the recommended dosage for patients without a gallbladder, 75 mg, even if they have not consumed any alcohol. These cases of pancreatitis may be occurring because eluxadoline causes a spasm in the sphincter of Oddi, which controls the flow of bile and pancreatic juice into the intestines. Eluxadoline works by decreasing bowel contractions, which reduces the frequency of diarrhea and reduces stomach or abdominal pain.

Related article: FDA approves eluxadoline to treat IBS-D in adults

Patients have been advised to talk to their health-care providers if they are taking eluxadoline and have had their gallbladders removed. They are also being warned to seek emergency medical attention if they experience the symptoms of pancreatitis

The manufacturer, Allergan, is working with the FDA to address this issue.

Health-care professionals are being urged to report adverse events or side effects related to the use of eluxadoline to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online at www.fda.gov/MedWatch/report.