Eluxadoline (Viberzi, Allergan), a drug used to treat irritable bowel syndrome (IBS) with diarrhea, should not be used in patients who do not have a gallbladder, the US Food and Drug Administration (FDA) said today.
A review by the agency found these patients have an increased risk for serious pancreatitis that could result in hospitalization or death.
As of February 2017, two deaths considered to be associated with eluxadoline have been reported to FDA. Both deaths occurred in patients who did not have a gallbladder.
One death was associated with pancreatitis and the other was associated with sphincter of Oddi spasm. The patient who had pancreatitis developed acute, severe abdominal pain, nausea, and vomiting within 1 hour of taking a single dose of eluxadoline, the FDA said.
The patient whose death was associated with sphincter of Oddi spasm had severe abdominal pain and vomiting shortly after taking the first dose of the drug. Both patients were hospitalized for treatment. "Notably, the patient who experienced pancreatitis died within 3 days of taking the initial Viberzi dose," the FDA said.
According to the March 15 safety communication, between May 2015, when eluxadoline was first approved, and February 2017, the FDA received 120 reports of serious cases of pancreatitis or death in the FDA Adverse Event Reporting System (FAERS) database.
Fifty-six of the 68 patients who reported their gallbladder status did not have a gallbladder and received the eluxadoline dose (75 mg) recommended for patients with no gallbladder. Of the 56 cases in patients who did not have a gallbladder, 21 reported that the patient did not abuse alcohol and 35 did not report the patient's alcohol use status.
"Symptoms of pancreatitis have occurred with just one or two doses of Viberzi at the recommended dosage for patients who do not have a gallbladder (75 mg), and who do not consume alcohol," the FDA said.
The FDA is working with the drug's manufacturer to address these safety concerns.
The FDA is advising health providers not to prescribe eluxadoline to patients who do not have a gallbladder and to consider alternative treatment options in these patients.
Healthcare providers are encouraged to report adverse events related to eluxadoline to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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Cite this: FDA: Avoid IBS Drug Viberzi in Patients With No Gallbladder - Medscape - Mar 15, 2017.