Irritable Bowel Syndrome Drug May Cause Pancreatitis
The FDA has received 120 reports of pancreatitis associated with eluxadoline (Viberzi).
A new FDA Drug Safety Podcast for healthcare professionals discussed the recent warning issued regarding an irritable bowel syndrome drug.
Earlier in March 2017, the FDA warned that the drug, eluxadoline (Viberzi), should not be used to treat patients who do not have a gallbladder. The new warning resulted from an FDA review that indicated patients without a gallbladder may have an increased risk of developing serious pancreatitis that could potentially be fatal, according to the FDA.
The drug is thought to cause a spasm of a digestive system muscle in the small intestine, resulting in pancreatitis in these patients.
The FDA is currently working with Allergan to address the concerns, according to the podcast.
The agency advises that healthcare professionals should not prescribe eluxadoline to patients without a gallbladder and explore other therapies, since there have been reports of both hospitalizations and deaths among these patients.
Pancreatitis symptoms have occurred as soon as the first dose of eluxadoline in those without a gallbladder who do not consume alcohol, according to the FDA. Therefore, patients should consider other treatment options.
The FDA advised that both over-the-counter (OTC) and prescription drugs can be used to treat symptoms of irritable bowel syndrome. Drugs such as OTC bismuth subsalicylate (Kaopectate, Pepto-Bismol), OTC loperamide (Imodium) and prescription diphenoxylate/atropine (Lomotil) can be used to treat diarrhea.
Other prescription drugs indicated to treat symptoms of irritable bowel syndrome include alosteron hydrochloride (Lotronext) and the antibiotic rifaximin (Xifaxan), according to the FDA.
Eluxadoline is indicated to treat patients with irritable bowel syndrome whose main symptom is diarrhea. The drug reduces bowel contractions, which lessens diarrhea and can help ease abdominal pain.
Since its approval in May 2015, the FDA has received 120 reports of serious pancreatitis, which led to death in some cases. The FDA reported that 56 out of 68 patients had no gallbladder and were treated with the recommended dose. Of 76 patients hospitalized due to pancreatitis, 2 without gallbladders died.
The FDA encourages physicians and patients to report new incidences of pancreatitis and other side effects experienced during treatment with eluxadoline to their MedWatch program.