FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi

WASHINGTON, April 3, 2017 - On March 15, 2017, FDA announced it is warning that Viberzi (active ingredient 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.

Health care professionals should not prescribe Viberzi to patients without 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 (brand names Kaopectate and Pepto-Bismol), OTC loperamide (brand name Imodium), and prescription medicine diphenoxylate/atropine (brand name Lomotil) for diarrhea. Other FDA-approved prescription medicines for IBS-D include alosetron hydrochloride (brand name Lotronex) and the antibiotic rifaximin (brand name Xifaxan).

Viberzi is used to treat irritable bowel syndrome in adults when the main symptom is diarrhea (IBS-D). The cause of IBS-D is unknown. Viberzi works by decreasing bowel contractions, leading to less diarrhea. In patients with IBS-D, Viberzi can help ease stomach-area or abdominal pain and improve stool consistency.

From Viberzi’s approval May 2015, through February 2017, FDA received 120 reports of serious cases of pancreatitis or death. Fifty six out of 68 patients had no gallbladder and received the currently recommended dosage of Viberzi. Of 76 patients hospitalized, two patients without gallbladders died. Some cases of serious pancreatitis or death also reported sphincter of Oddi spasm.

Report side effects involving Viberzi to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

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