FDA Warns of Increased Risk of Serious Pancreatitis With Viberzi

Irritable bowel drug should be avoided in patients without a gallbladder

The FDA is warning health care professionals that eluxadoline (Viberzi), a medication used to treat patients with irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found that 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 is working with Allergan, the manufacturer of eluxadoline, to address these safety concerns.

Health care professionals should not prescribe eluxadoline to patients who do not have a gallbladder and should consider alternative treatment options in these patients. Hospitalizations and deaths due to pancreatitis have been reported with the use of eluxadoline in patients who do not have a gallbladder. Symptoms of pancreatitis have occurred with only one or two doses of eluxadoline at the recommended dose for patients who do not have a gallbladder (75 mg) and who do not consume alcohol.

Physicians may consider both over-the-counter (OTC) or FDA-approved prescription medications to treat symptoms associated with IBS-D, such as OTC bismuth subsalicylate (Kaopectate and Pepto-Bismol), OTC loperamide (Imodium), and the prescription medication diphenoxylate/atropine (Lomotil, Pfizer) for diarrhea. Physicians may also consider OTC medications for gas relief, such as simethicone (Gas-X, Mylicon). Other FDA-approved prescription medications for IBS-D include alosetron hydrochloride (Lotronex, Sebela Pharmaceuticals) and the antibiotic rifaximin (Xifaxan, Salix Pharmaceuticals).

IBS-D affects the large intestine and causes cramping, stomach-area or abdominal pain, bloating, gas, and diarrhea. The cause of IBS-D is not known. Eluxadoline works by reducing bowel contractions, which leads to less diarrhea. In patients with IBS-D, eluxadoline can help ease stomach-area or abdomen pain and improve stool consistency.

From May 2015, when eluxadoline was first approved, through February 2017, the FDA received 120 reports of serious cases of pancreatitis or death. Among the 68 patients who reported their gallbladder status, 56 of them did not have a gallbladder and received the currently recommended dosage of eluxadoline. Seventy-six patients were hospitalized, two of whom died. These two patients did not have a gallbladder. Some cases of serious pancreatitis or death also involved sphincter of Oddi spasm or abdominal pain

Source: FDA; March 15, 2017.