The prescription drug Viberzi is approved by the U.S. Food and Drug Administration (FDA) to treat irritable bowel syndrome with diarrhea (IBS-D). The FDA recently announced that patients who have had the gallbladder removed should not be taking the medication because of a risk of developing pancreatitis. The announcement comes after a recent review that found these particular patients were at a greater risk of developing the condition while on the drug and that it could lead to hospitalization or even death.

Viberzi and IBS-D

Viberzi is the brand name for the drug called eluxadoline, used to treat irritable bowel syndrome with the main symptom being diarrhea. IBS-D causes cramping, pain, bloating, gas, and diarrhea, and affects the large intestine. What causes the illness is unknown, but Viberzi has been proven to relieve the pain of IBS-D as well as diarrhea. Viberzi has been on the market since it was approved for treating IBS-D in May of 2015.

Viberzi and Pancreatitis

Since May of 2015 the FDA has collected 120 reports about pancreatitis through the adverse events reporting system. The reports were of very serious cases of the disease, some of which ended in death. Sixty-eight of the reports included information about the gallbladder, and 58 of those patients had their gallbladder removed. Those who died did not have a gallbladder. Seventy-six of the 120 reported patients were hospitalized. The pancreatitis may be caused by a spasm in a small intestine muscle. Pancreatitis is inflammation of the pancreas, and when acute it can become serious quickly and even be fatal if not treated immediately.

The FDA is recommending that physicians do not prescribe Viberzi to patients who have had their gallbladder removed. Physicians are urged to recommend over-the-counter medications for the symptoms of IBS-D for these patients: bismuth subsalicylate or loperamide for diarrhea and simethicone for gas. Prescription medications the FDA recommends as alternatives to Viberizi include Lomotil (diphenoxylate/atropine), Lotronex (alosetron hydrochloride), and Xifaxan (rifaximin).

Recommendations for Patients

The FDA recommends that patients who have been using Viberzi talk to their doctors about the risks and about alternative medications and lifestyle changes for treating IBS-D. This is especially important for any patient who has had their gallbladder removed previously. The gallbladder is a small organ that stores bile for digesting fat and it is often removed because of the formation of gallstones or when the gallbladder isn’t working properly. This dysfunction can cause symptoms like indigestion, nausea, vomiting, and pain after eating.

The FDA’s adverse events reports on Viberzi indicate that the symptoms of pancreatitis have occurred in some patients even after just one or two doses of the medication. The signs of pancreatitis include new and progressive pain in the stomach area or upper right abdomen that moves to the back and shoulder and nausea with vomiting. Patients experiencing these symptoms should stop taking Viberzi immediately and seek emergency medical help.

Both patients and physicians are encouraged to report any adverse side effects of Viberzi to the FDA. The FDA will continue to investigate this medication and its link to pancreatitis. As of now there is no plan to recall the medication, but it needs to be studied further.