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FDA Drug Safety Communication: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder

The U.S. Food and Drug Administration (FDA) 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, we are working with the Viberzi manufacturer, Allergan, to address these safety concerns.

Patients should talk to your health care professional about how to control your symptoms of irritable bowel syndrome with diarrhea (IBS-D), particularly if you do not have a gallbladder. The gallbladder is an organ that stores bile, one of the body's digestive juices that helps in the digestion of fat. Stop taking Viberzi right away and get emergency medical care if you develop new or worsening stomach-area or abdomen pain, or pain in the upper right side of your stomach-area or abdomen that may move to your back or shoulder. This pain may occur with nausea and vomiting. These may be symptoms of pancreatitis, an inflammation of the pancreas an organ important in digestion; or spasm of the sphincter of Oddi, a muscular valve in the small intestine that controls the flow of digestive juices to the gut.

Health care professionals should not prescribe Viberzi in 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 Viberzi use in patients who do not have a gallbladder. Symptoms of pancreatitis have occurred with just one or two doses of Viberzi at the recommended dosage for patients who do not have a gallbladder (75 mg), and who do not consume alcohol.

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

Viberzi is a prescription medicine used to treat irritable bowel syndrome in adults when the main symptom is diarrhea (IBS-D). IBS-D affects the large intestine and causes cramping, stomach-area or abdomen pain, bloating, gas, and diarrhea. The cause of IBS-D is not known. Viberzi works by decreasing bowel contractions, which leads to less diarrhea. In patients with IBS-D, Viberzi can help ease stomach-area or abdomen pain and improve stool consistency.

From May 2015, when Viberzi was first approved, through February 2017, 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 Viberzi. Seventy-six patients were hospitalized, of which two patients died. These two patients did not have a gallbladder. Some cases of serious pancreatitis or death also reported sphincter of Oddi spasm (n=6) or abdomen pain (n=16) (see Data Summary).

We urge patients and health care professionals to report side effects involving Viberzi (eluxadoline) or other medicines to the FDA MedWatch program.

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