Accepting Cases

Viberzi

Viberzi is an antidiarrheal drug prescribed to treat irritable bowel syndrome with diarrhea (IBS-D) in adults. The drug’s main ingredient is eluxadoline. Allergan got approval to sell the medication in the U.S. in 2015.

The U.S. Food and Drug Administration approved Viberzi in 2015 to treat irritable bowel syndrome with diarrhea (IBS-D). The medication decreases abdominal pain associated with IBS-D. It also makes stool less watery.

The medication works within the intestines to slow the movement of food during digestion. It activates or blocks certain opioid receptors in the digestive tract that affect digestion, pain sensation, and intestinal fluid secretion. This causes the nerves in the bowels to be less sensitive to stimuli thereby cutting the amount of bowel contractions a person with IBS-D may experience.

Allergan manufactures the drug using the active ingredient eluxadoline, which is under Schedule IV of the Controlled Substances Act. According to GoodRx, the average retail price for sixty 100mg tablets is $1,380.

Taking Viberzi Safely

Viberzi is available in 75mg and 100mg tablets. The typical recommended dosage is 100mg taken twice daily by mouth with food.

Doctors may recommend certain patients take 75mg twice daily. These patients include those who:
  • Cannot tolerate 100mg dose
  • Are also taking OATP1B1 inhibitors
  • Have mild or moderate liver impairment

Two doses should not be taken at the same time to make up for a missed dose. A doctor may recommend stopping treatment if a patient experiences side effects, such as severe constipation.

Taking Viberzi with other substances may change the way the medications work in the body. This can be unsafe and potentially harmful to patients’ health.

Substances to ask your doctor about include prescription and over-the-counter drugs and supplements.

Drugs that may interact adversely with Viberzi include:
  • OATP1B1 inhibitors (i.e. cyclosporine, antiretrovirals like ritonavir, rifampin)
  • Strong CYP inhibitors (i.e. ciprofloxacin, gemfibrozil, fluconazole, clarithromycin)
  • Drugs that cause constipation (i.e. alosetron, anticholinergics, opioids)
  • OATP1B1 and BCRP substrate (i.e. rosuvastatin)
  • CYP3A substrates (i.e. alfentanil, cyclosporine, ergotamine, fentanyl, quinidine)

FDA Warning for Patients Without a Gallbladder

Gallbladder Illustration
The U.S. Food and Drug Administration warns patients without their gallbladder not to take Viberzi. The above image is an illustration of a gallbladder.

In March 2017, the FDA issued a safety communication warning patients without a gallbladder to avoid taking Viberzi.

The drug causes an increased risk of serious pancreatitis in patients missing their gallbladder, the FDA said. This severe condition could lead to hospitalization or death.

The FDA said pancreatitis in these patients may result from a spasm of a certain digestive system muscle found in the small intestine.

The regulatory agency said it would work with Allergan to address safety concerns. As of October 2018, the FDA has not issued any updates.

People who suffered pancreatitis while prescribed Viberzi are filing lawsuits that accuse the manufacturer of failing to warn of the risk.

Did you develop pancreatitis while taking Viberzi? Get a Free Case Review

People Who Should Not Take Viberzi

Viberzi is only approved for use in adults. It’s unknown whether the drug is safe or effective for children.

While the drug works for most adults with IBS-D, it is not recommended for everyone.

Contraindications Reasons
Patients without gallbladders increased risk of developing serious adverse reactions of pancreatitis and/or sphincter of Oddi spasm
People with biliary duct obstruction or sphincter or Oddi disease increased risk for sphincter of Oddi spasm
Those who drink more than three alcoholic beverages per day, or suffer from alcoholism or abuse alcohol increased risk for acute pancreatitis
Individuals with a history of pancreatic problems increased risk for acute pancreatitis
Those with severe liver problems risk for significantly increased plasma concentrations of eluxadoline
Those with chronic or severe constipation of a gastrointestinal obstruction risk for severe complications of bowel obstruction
People with a known sensitivity to the drug Serious hypersensitivity reactions, including anaphylaxis, can occur after the first or second dose
Source: Viberzi’s FDA-approved drug label

Pregnancy and Breastfeeding

There have been no Viberzi studies in pregnant women, so it’s unknown how the drug affects expectant mothers and fetuses.

Eluxadoline was present in rat milk in animal studies. Before taking the drug, patients should tell their doctor if they are breastfeeding.

Other IBS-D Medications

There are several drugs available to treat diarrhea associated with IBS. Consumers can buy some of these medications over-the-counter. Others need a prescription.

Alternatives to Viberzi include:
  • Imodium, Lomotil, Loperamide, Pepto-Bismol (diarrhea medicines)
  • Xifaxin (antibiotic)
  • Lotronex, Levsin (gastrointestinal medications)
  • Probiotic, Florastor (intestinal flora modifier)
  • Enteragam (alternative therapy medication)

Please seek the advice of a medical professional before making health care decisions.

Related Pages
Kristin Compton
Written By Kristin Compton Writer

Kristin Compton's background is in legal studies. She worked as a paralegal before joining Drugwatch as a writer and researcher. She was also a member of the National Association of Legal Assistants. A mother and longtime patient, she has firsthand experience of the harmful effects prescription drugs can have on women and their children. Some of her qualifications include:

  • Bachelor of Arts in Legal Studies | Pre-Law from University of West Florida
  • Past employment with The Health Law Firm and Kerrigan, Estess, Rankin, McLeod & Thompson LLC
  • Personal experience battling severe food allergies, asthma and high-risk pregnancies
Edited By

9 Cited Research Articles

  1. U.S. National Library of Medicine. (2018, April 25). Label: Viberzi – eluxadoline tablet, film coated. NIH. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7821bd40-4c84-4984-951b-6436ae20421a
  2. FDA. (2017, March 15). FDA Drug Safety Communication: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm546154.htm
  3. CenterWatch. (n.d.). Viberzi (eluxadoline). Retrieved from https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/100080/viberzi-eluxadoline
  4. FDA. (2015, June 19). Drug Trials Snapshots: Viberzi. Retrieved from https://www.fda.gov/Drugs/InformationOnDrugs/ucm451514.htm
  5. Allergan plc. (2016, January 21). Viberzi (eluxadoline) Phase III Trial Results Published in the New England Journal of Medicine. Retrieved from https://www.allergan.com/news/news/thomson-reuters/viberzi-eluxadoline-phase-iii-trial-results-publi
  6. Treato. (n.d.). Viberzi Alternatives. Retrieved from https://treato.com/Viberzi,Alternatives/?a=s
  7. Bolen, PhD, B. (2018, January 7). Treating IBS With Viberzi: Alleviating the Symptoms of Irritable Bowel Syndrome. Verywell Health. Retrieved from https://www.verywellhealth.com/viberzi-for-ibs-1945157
  8. Allergan. (n.d.). What Is Viberzi? Retrieved from https://www.viberzi.com/what_is_viberzi
  9. Holzer, P. (2009, June). Opioid receptors in the gastrointestinal tract. Science Direct. Retrieved from https://www.sciencedirect.com/science/article/pii/S0167011509000731
View All Sources
Who Am I Calling?

Calling this number connects you with Wilson and Peterson, LLP or one of its trusted legal partners. A law firm representative will review your case for free.

Wilson and Peterson, LLP funds Drugwatch because it supports the organization’s mission to keep people safe from dangerous drugs and medical devices.

(855) 781-7449