NICE in the United Kingdom Gives Positive Recommendation for Eluxadoline (Truberzi) for IBS-D

July 31, 2017

Today, via the social media of the IBS Network, the U.K. charity for irritable bowel syndrome, IBS Impact received the following linked press release from Allergan, the pharmaceutical company for eluxadoline, which is known in the U.K. and throughout the European Union by the brand name Truberzi. This is the same medication which is known in the U.S. and Canada by the brand name Viberzi. It is a twice-daily oral medication for irritable bowel syndrome with diarrhea (IBS-D)

According to the press release, dated July 27, 2017, the National Institute of Health and Care Excellence, still known by its former acronym, NICE, issued a Final Appraisal Determination that the National Health Service (NHS) make eluxadoline available to adults with IBS-D who have not responded to, or for medical reasons, cannot use other IBS treatment interventions usually offered. If there is no appeal to this determination, this guidance will be published in August, and availability under the NHS is expected sometime this fall.

Eluxadoline was originally approved for use in the EU by the European Commission in September 2016, by the Food and Drug Administration (FDA) in the United States in May 2015 and by Health Canada in March 2017. It has been used successfully by many people with IBS-D throughout North America and the European Union in that time frame, but as reported by this blog on March 15, 2017, the FDA issued a warning to U.S. physicians that eluxadoline should not be prescribed to patients who do not have a gallbladder because of reports of many cases of serious pancreatitis and two deaths in that subgroup. We advise anyone considering any specific IBS medication or treatment to read available evidence-based information, to familiarize themselves with the benefits and risks, and to consult their own doctors as to if the given intervention is worth trying in their specific situations. IBS Impact focuses on awareness and advocacy and does not endorse particular interventions, but does encourage accurate and up to date information from reputable sources so that individuals with IBS and their families can make the most informed choices for their own needs and desires.


U.S. Food and Drug Administration Issues Drug Safety Communication for IBS-D Medication Eluxadoline (Viberzi), March 2017

March 15, 2017

Today, March 15, 2017, IBS Impact learned via IFFGD social media that the U.S. Food and Drug Administration (FDA) issued a drug safety communication for eluxadoline (also known by the brand name Viberzi), currently used in treating irritable bowel syndrome with diarrhea in adults, 18 and older, both men and women. This warning applies specifically to people without a gallbladder, whom the FDA advises should not take eluxadoline (Viberzi). There is an apparent high risk of serious pancreatitis, which has resulted in many reported cases of hospitalization and two deaths.

According to the FDA warning notice issued today, as of February 2017, in the 21 months since eluxadoline’s FDA approval in May 2015, the FDA received 120 reports of serious pancreatitis or death. 76 of the 120 patients reported required hospitalization and 2 of them died. In 68 of the patients, it is known whether or not they had a gallbladder. 56 did not have a gallbladder, including the 2 individuals who died. 22 of the 120 cases of serious pancreatitis or death reported additional complications. As a result, the FDA is advising that those with IBS-D who do not have a gallbladder not be prescribed eluxadoline (Viberzi) at this time. For physicians, the drug safety communication includes several suggestions of alternative over-the-counter and prescription medications for IBS-D.

The FDA is working with the pharmaceutical company Allergan to address the safety concerns and urges patients and physicians to report any adverse events to the FDA.  There are no announced changes in safety concerns or recommendations regarding eluxadoline (Viberzi)  for those individuals who do have a gallbladder.

IBS Impact urges readers who have IBS-D and no gallbladder and are currently taking eluxadoline (Viberzi) to consult their physicians promptly. We advise anyone considering any specific IBS medication or treatment to read available evidence-based information, to familiarize themselves with the benefits and risks, and to consult their own doctors as to if the given intervention is worth trying in their specific situations. IBS Impact focuses on awareness and advocacy and does not endorse particular interventions, but does encourage accurate and up to date information from reputable sources so that individuals with IBS and their families can make the most informed choices for their own needs and desires.