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Risk factors for drug-related impaired gastric emptying: a pharmacovigilance analysis of the FDA adverse event
Jie-Hai Chen1, Jia-Cong Chen1, Ya-Jing Mei1
1Department of Anesthesiology, Dongguan Maternal and Child Healthcare Hospital, Dongguan, Guangdong, China.
Background:
Pulmonary aspiration remains a major perioperative patient safety issue. Drug-related impaired gastric emptying (IGE) is a recognized yet underappreciated risk factor for aspiration. With the increasing use of medications such as glucagon-like peptide-1 receptor agonists (GLP-1RAs), concerns have grown regarding their potential to delay gastric emptying and thereby elevate aspiration risk. However, real-world data on drug-related IGE remain limited.
Objective:
To identify risk factors for drug-related IGE using real-world pharmacovigilance data from the FDA Adverse Event Reporting System (FAERS).
Methods:
A retrospective pharmacovigilance study was conducted using FAERS data from Q1 2004 through Q2 2025. Disproportionality analysis, logistic regression, LASSO regression and time-to-onset analysis were performed to investigate the association between drugs and IGE from different perspectives.
Results:
A total of 731 drugs related to IGE. Six of the top 10 most frequently reported drugs associated with IGE were antidiabetic agents, including five GLP-1RAs: semaglutide, dulaglutide, tirzepatide, exenatide, and liraglutide. Multi-factor analysis identified female sex, age <63 years, and exposure to any of nine specific drugs-including GLP-1RAs, insulin lispro, sodium oxybate, olmesartan, and esomeprazole-as independent risk factors for drug-related IGE. The model achieved an ROC-AUC of 0.739, indicating good discriminatory capability. Time-to-onset analysis revealed an early-failure pattern for all nine drugs.
Conclusion:
Our study shows that female sex, younger age, and use of specific medications are associated with an increased risk of drug-related IGE. These findings may provide valuable evidence to support the early recognition of drug-related IGE and for optimizing anaesthetic plans and perioperative personalized fasting strategies.
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