Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

IBS Patients Taking Viberzi May Be at Increased Risk of Pancreatitis



Since Viberzi’s approval in May 2015 to February of this year, the FDA has received 120 adverse event reports of pancreatitis or death in patients taking the drug.

Share this!

March 22, 2017 | by Sarah Hand, M.Sc.

According to a recent drug safety communication issued by the US Food and Drug Administration (FDA), patients with irritable bowel syndrome (IBS) with diarrhea should not be treated using Viberzi (eluxadoline), if they do not have a gallbladder. Since Viberzi’s approval in May 2015 to February of this year, the FDA has received 120 adverse event reports of pancreatitis or death in patients taking the drug.

IBS is a gastrointestinal disorder which affects up to 10 to 15 percent of the world’s population, causing symptoms such as cramping, pain, bloating, gas and diarrhea. Viberzi was designed to treat IBS patients whose primary symptom is diarrhea, and works by decreasing bowel contractions to improve stool consistency.

Of the 120 patients who reported an adverse event while taking Viberzi, 56 reported that they did not have a gallbladder. Seventy-six patients were hospitalized due to their pancreatitis, with two of these patients dying of the condition. Both of these patients did 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,” said the statement issued by the FDA. “We urge patients and healthcare professionals to report side effects involving Viberzi (eluxadoline) or other medicines to the FDA MedWatch program, using the information in the ‘Contact FDA’ box at the bottom of the page.”

Between May 2015 and July 2016, about 64,000 Viberzi prescriptions were filled by pharmacies in the US. In 2016, the drug brought in over $93 million in sales.

The FDA is reportedly working with Allergan, the manufacturer of Viberzi, to investigate the safety concerns. The agency has recommended that physicians refrain from prescribing the IBS medication to patients without a gallbladder, and instead consider some of the other over-the-counter (OTC) and prescription medications available for symptom relief.

To treat the diarrheal symptoms of IBS, the FDA recommends OTC drugs including bismuth subsalicylate (Kaopectate and Pepto-Bismol) and loperamide (Imodium), or the prescription drug diphenoxylate/ atropine (Lomotil). OTC simethicone (Gas-X, Mylicon), is being recommended by the agency to provide patients with gas relief.

Keywords: IBS, Pancreatitis, Adverse Events


Share this with your colleagues!

Kite Pharma Secures FDA Approval for CAR-T Immunotherapy

October 20, 2017 - Kite Pharma’s Yescarta (axicabtagene ciloleucel) has become the second CAR-T immunotherapy to be approved in the US, with an indication in treating adult patients with relapsed or refractory large B-cell lymphoma.

Featured In: Biotech News

Fallopian Tubes Found to be Site of Origin for Most Ovarian Cancers

October 20, 2017 - This year, over 22,000 women will be diagnosed with ovarian cancer but a new study conducted by researchers at Perlmutter Cancer Center at NYU Langone Health suggests that most of these malignancies begin in another part of the reproductive system: the fallopian tubes.

Featured In: Life Science News

Food Companies are Looking for the Next Sriracha

October 19, 2017 - The Sriracha trend might be coming to an end and companies are looking for the next big hot sauce star to feature in their line-up.

Featured In: Food News


Five Reasons Why Toronto is Emerging as a Major Life Sciences Hub


Brexit – Separating Fact from Fiction

Evolving Best Practices for Working with Authors of Scientific Publications – Authorship and Beyond

Human Whole-Genome Sequencing in a New Era Defined by the Illumina® HiSeq X® and NovaSeq™ Platforms

Clinical Event Adjudication: Comprehensive and Efficient Dossier Review Using a Global On-Line Solution

Copyright © 2016-2017 Honeycomb Worldwide Inc.