ArticleTherapeutic advances in gastroenterology2021
Post-marketing reports of pancreatitis in eluxadoline-treated patients pre and post US label change.
Article in Therapeutic advances in gastroenterology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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Who cites it
3 citing papers in PubMed, 4 citations in OpenAlex.
- Comprehensive pharmacovigilance assessment of pairwise drug-drug interactions and acute pancreatitis in the FDA adverse event reporting system: focus on incretin-based drugs.Frontiers in drug safety and regulation · 2026Article
- Drug-induced pancreatitis: a real-world analysis of the FDA Adverse Event Reporting System and network pharmacology.Frontiers in pharmacology · 2025Article
- Current and Future Therapeutic Options for Irritable Bowel Syndrome with Diarrhea and Functional Diarrhea.Digestive diseases and sciences · 2023Review
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Authors and funding
5 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEluxadoline, a United States Food and Drug Administration (FDA)-approved treatment for irritable bowel syndrome with diarrhea (IBS-D), underwent a change to its US prescribing information on 21 April 2017, contraindicating it in patients without a gallbladder due to increased risk of pancreatitis. This study aimed to elucidate the potential role of eluxadoline's label change on the number of reported spontaneous adverse events (AEs) of pancreatitis.
methodsA pharmacovigilance database (Oracle Argus) was searched for eluxadoline use and spontaneously reported pancreatitis cases from 1 January 2016 to 30 June 2018. Pancreatitis cases were reported as a proportion of the total number of reported AE cases in the safety database. The FDA's adverse event reporting system (AERS) was also interrogated for cases of pancreatitis concomitantly reported with eluxadoline use.
resultsIn patients who received eluxadoline, 273 reported cases of pancreatitis were recorded (total AEs
conclusionsWhile cautious interpretation is warranted, post-marketing data indicate that the contraindication of eluxadoline in patients without a gallbladder led to reduced reported cases of pancreatitis, with no additional reports of moderately severe or severe cases. Eluxadoline is a safe and well-tolerated treatment option for IBS-D when used according to the label.
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