FOOD AND DRUG ADMINISTRATION WARNS OF SERIOUS PANCREATITIS WITH USE OF ELUXADOLINE (VIBERZI)

March 23, 2017

Here’s an important alert for patients who are taking eluxadoline (Viberzi), which is approved to treat irritable bowel syndrome when the main symptom is diarrhea (IBS-D). Public Citizen’s Health Research Group has designated this drug as Do Not Use.

On Mar. 15, 2017, the Food and Drug Administration (FDA) released a warning on the risk of serious pancreatitis (inflammation of the pancreas) that could result in hospitalization or death in patients who are taking eluxadoline.[1]

The FDA based its alert on 120 cases of serious pancreatitis reported to the FDA from May 2015, when eluxadoline was first approved, through February 2017. At least 48 of the cases occurred after a patient took just one or two doses of eluxadoline; 76 of the cases resulted in hospitalization, and two patients died. One of the two patients died within three days of taking the first eluxadoline dose.

The agency has recommended against the use of eluxadoline in patients who do not have a gallbladder, as well as in patients with a history of any of the following: gallbladder blockage, pancreatitis, serious liver problems, severe or chronic constipation, intestinal obstruction or alcohol abuse problems (including drinking more than three drinks per day).

What You Can Do

Do not use eluxadoline. If you have IBS-D, talk with your doctor about other treatments, including avoiding foods that worsen your symptoms, eating more slowly, avoiding overeating, avoiding carbonated drinks and beginning a healthy exercise regimen.

To see the FDA’s safety alert, visit the following link: https://www.fda.gov/Drugs/DrugSafety/ucm546154.htm.

References

[1] Food and Drug Administration. FDA drug safety communication: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder. March 15, 2017. https://www.fda.gov/Drugs/DrugSafety/ucm546154.htm. Accessed March 17, 2017.