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. 2025 May 21;15(5):e088512.
doi: 10.1136/bmjopen-2024-088512.

Assessing the association between drug use and ischaemic colitis: a retrospective pharmacovigilance study using FDA Adverse Event data

Jie An  1 , Kaiqi Wu  2 , Teng Wu  3 , Pengyang Xu  3 , Chuanli Yang  1   4 , Yunhe Fan  1 , Qing Li  5 , Xiushan Dong  6
Affiliations

Assessing the association between drug use and ischaemic colitis: a retrospective pharmacovigilance study using FDA Adverse Event data

Jie An et al. BMJ Open. .

Abstract

Objective: Drug-induced ischaemic colitis is a significant adverse event (AE) in clinical practice. This study aimed to recognise the top drugs associated with the risk of ischaemic colitis based on the FDA Adverse Event Reporting System (FAERS) database.

Design: A cross-sectional design.

Setting: All data retrieved from the FAERS database from the first quarter of 2004 to the fourth quarter of 2023.

Participants: A total of 5664 drug-induced ischaemic colitis AEs eligible for screening.

Primary and secondary outcome measures: The Medical Dictionary for Regulatory Activities was used to identify ischaemic colitis (code: 10009895) cases. Disproportionality analysis for drug-associated ischaemic colitis signals.

Results: Drug-induced ischaemic colitis AEs were more prevalent in females (60.12%) and individuals aged ≥65 years (34.25%). The common outcomes were hospitalisation (46.85%) and death (9.73%). Disproportionality analysis identified 91 ischaemic colitis signals and the top 30 drugs mainly involved in the gastrointestinal and nervous systems. The top five drugs with the highest reported OR, proportional reporting ratio, information component and the empirical Bayesian geometric mean, were alosetron, tegaserod, osmoprep, naratriptan and kayexalate. Additionally, 20 of the top 30 drugs did not have ischaemic colitis risk indicated in the package insert.

Conclusions: This study identified key drugs associated with ischaemic colitis, particularly alosetron, tegaserod, osmoprep, naratriptan and kayexalate. Notably, two-thirds of these drugs lacked ischaemic colitis warnings in their package inserts. These findings underscore the need for greater clinical vigilance, improved regulatory oversight and further research to clarify underlying mechanisms and support safer medication use.

Keywords: Adverse events; Drug Utilization; Gastroduodenal disease.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1. Number of reported AEs of drug-induced ischaemic colitis from 2004 to 2023. AE, adverse event.
See this image and copyright information in PMC

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