People Without Gallbladders Should Not Use IBS Drug, FDA Cautions

The US Food and Drug Administration (FDA) today warned that eluxadoline (Viberzi/ Allergan), a treatment for irritable bowel syndrome with diarrhea (IBS-D), should not be given to patients who do not have gallbladders. These patients would have an increased risk of developing severe pancreatitis, possibly resulting in hospitalization or death, the agency said.

Since Viberzi’s initial FDA approval in May 2015, officials have received 120 reports of cases of serious pancreatitis and deaths related to using the drug.

The prescription medication is administered to IBS-D patients to decrease bowel contractions, ultimately leading to fewer incidences of diarrhea.

Officials reported that these patients exhibited signs of pancreatitis even with just 1 or 2 doses of Viberzi at the recommended dosage (75mg). The patients also experienced spasms of the sphincter of Oddi, a muscular valve in the small intestine that controls the flow of digestive juices to the gut.

Health care providers should advise patients to immediately stop taking Viberzi if they develop any of the following:

· New or worsening stomach-area or abdomen pain

· Pain in the upper right side of the stomach-area or abdomen that could move to the back or shoulder

· Stomach-area pain with nausea and vomiting

Physicians are advised to consider alternative treatment options for patients without gallbladders. Potentially effective options include: over-the-counter (OTC) bismuth subsalicylate (Kaopectate and Pepto-Bismol), OTC loperamide (Imodium), and FDA-approved prescription medicine diphenoxylate/atropine (Lotomil).