Risk of Pancreatitis Following Treatment of Irritable Bowel Syndrome with Eluxadoline

Gawron AJ1, Bielefeldt K2. Clin Gastroenterol Hepatol. 2017 Aug 10. pii: S1542-3565(17)30935-7. doi: 10.1016/j.cgh.2017.08.006. [Epub ahead of print]
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1 George E. Wahlen VA Medical Center, Salt Lake City Utah; Division of Gastroenterology, Hepatology, and Nutrition, University of Utah, Salt Lake City; Salt Lake City Specialty Care Center of Innovation, Salt Lake City Utah. 2 George E. Wahlen VA Medical Center, Salt Lake City Utah. Electronic address: Klaus.bielefeldt@va.gov.


BACKGROUND & AIMS: The Food and Drug Administration approved eluxadoline for the treatment of diarrhea-predominant irritable bowel syndrome despite cases of pancreatitis in early-stage trials. We investigated the frequency of pancreatitis attributed to eluxadoline in post-marketing surveillance.

METHODS: We extracted reports on eluxadoline submitted to the Federal Adverse Event Reporting System from January through September 2016. We collected data on patient age and sex, event date, reporting entity (consumer, physician, pharmacist, legal worker, or other), medications, dosages, presumed role in the event (coinciding, primary, or secondary suspect), treatment indication, and outcome (death, life threatening, hospitalization, disability, or other). We compared data for eluxadoline with data from antidiarrheals, oxycodone, and rifaximin using the κ2 test, Kruskal Wallis rank test, and analysis of variance; findings with P<.05 were considered statistically significant.

RESULTS: Pancreatitis accounted for 16.4% of the 597 reports of adverse events linked to eluxadoline; 53 cases required hospitalization. Pancreatitis listed as treatment complication of other agents in significantly lower proportions of cases (loperamide, 0.3%; diphenoxylate, 0.4%; oxycodone, 0.2%; rifaximin, 0.5%), with 75% of these submissions not considering the agent as causal.

CONCLUSION: In an analysis of reports on eluxadoline submitted to the Federal Adverse Event Reporting System, we confirmed a previously reported risk of pancreatitis associated with eluxadoline. The need for hospitalization in at least half of these instances and a recent report of 2 fatalities should prompt reassessments of the agent's risk-benefit ratio.

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