Multinational pharmacovigilance assessment of drug-associated esophageal ulceration and perforation: evidence from FAERS, JADER, and Canada Vigilance
Abstract
Background: Drug-associated esophageal ulceration and perforation are uncommon but clinically serious adverse events. This study characterized post-marketing reporting patterns for these events across three spontaneous reporting systems.
Methods: Reports from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), Japanese Adverse Drug Event Report database (JADER), and Canada Vigilance from 2004 to 2025 were analyzed using predefined Medical Dictionary for Regulatory Activities (MedDRA) preferred terms. Disproportionality was assessed using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). In FAERS, least absolute shrinkage and selection operator (LASSO) regression followed by multivariable logistic regression was used for exploratory signal prioritization. Reported time-to-onset was summarized for drug-report records with valid therapy start and event onset dates.
Results: FAERS contained 8,061 reports meeting the prespecified composite case definition. Among the 50 most frequently reported FAERS primary-suspect drugs, the largest disproportionality estimates were observed for doxycycline (ROR 41.15, 95% confidence interval [CI] 36.47-46.43), alendronic acid (ROR 21.45, 95% CI 19.14-24.04), and clindamycin (ROR 18.59, 95% CI 15.40-22.44). JADER and Canada Vigilance showed descriptively overlapping but heterogeneous reporting…
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