Drug-induced intestinal obstruction: insights from the FDA Adverse Event Reporting System

Intestinal obstruction is a severe abdominal condition that can be triggered by various medications; however, the drugs most strongly and frequently linked to this adverse event (AE) remain insufficiently defined in the current medical literature.

This study sought to systematically identify and evaluate medications most strongly and consistently associated with intestinal obstruction by analyzing real-world evidence from a large pharmacovigilance database.

We conducted a retrospective, observational pharmacovigilance study.

Reports submitted to the U.S. FDA Adverse Event Reporting System (FAERS) between January 2004 and June 2024 were analyzed. Disproportionality analyses using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Empirical Bayesian Geometric Mean, and Information Component were conducted to identify significant safety signals associated with drug-induced intestinal obstruction.

Among 21,433,114 AE reports, 60,814 (0.28%) involved intestinal obstruction. Humira (10,356 cases) was the most frequently reported drug, followed by Remicade (2223 cases), Avastin (1580 cases), Vedolizumab (1385 cases), Clozaril (1229 cases), and Accutane (1088 cases). Disproportionality analysis revealed that the top five drugs with the highest ROR and PRR were Accutane, Teduglutide, Lonsurf, Avastin, and Lynparza. Among the top 50 drugs, 47 lacked clear labeling in their drug packaging.

Our findings, derived from FAERS signal detection, identify drug-event pairs that warrant further clinical evaluation. These results should not be interpreted as evidence of causality. The high volume of reports associated with certain drugs may reflect usage patterns, underlying disease conditions, or reporting behaviors. Caution should be exercised in clinical translation.