FAERS analysis links GLP-1RAs, female sex, and younger age to increased drug-related impaired gastric emptying
Background
Pulmonary aspiration during surgery remains a significant patient safety concern, often linked to impaired gastric emptying (IGE). While drug-related IGE is a known risk, its prevalence and specific triggers are underappreciated. The rising use of medications like glucagon-like peptide-1 receptor agonists (GLP-1RAs) for diabetes and weight management has heightened concerns about their potential to delay gastric emptying, thereby increasing aspiration risk. This study addresses the gap in real-world data on specific drug-related IGE risk factors.
Study Design
A retrospective pharmacovigilance study analyzed real-world data from the FDA Adverse Event Reporting System (FAERS) spanning Q1 2004 through Q2 2025. Researchers performed disproportionality analysis, logistic regression, LASSO regression, and time-to-onset analysis to identify associations between drugs and IGE. The analysis aimed to pinpoint independent risk factors for drug-related IGE from various perspectives. The study did not involve direct patient intervention but rather analyzed reported adverse events.
Results
The analysis identified 731 drugs associated with IGE. Notably, six of the top 10 most frequently reported drugs linked to IGE were antidiabetic agents, with five being GLP-1RAs: semaglutide, dulaglutide, tirzepatide, exenatide, and liraglutide. Multi-factor analysis revealed that female sex, age <63 years, and exposure to any of nine specific drugs were independent risk factors for drug-related IGE. These drugs included the GLP-1RAs, insulin lispro, sodium oxybate, olmesartan, and esomeprazole. The predictive model demonstrated good discriminatory capability with an ROC-AUC of 0.739. Time-to-onset analysis indicated an early-failure pattern for all nine identified drugs. This suggests that IGE events, when they occur, tend to manifest relatively soon after drug initiation.
Female sex, age <63 years, and specific medications (including GLP-1RAs) were identified as independent risk factors for drug-related impaired gastric emptying.
Key Findings
- 731 drugs were found to be associated with impaired gastric emptying (IGE) in FAERS data.
- Five GLP-1RAs (semaglutide, dulaglutide, tirzepatide, exenatide, liraglutide) were among the top 10 most frequently reported drugs linked to IGE.
- Female sex and age <63 years were identified as independent risk factors for drug-related IGE.
- Specific drugs, including GLP-1RAs, insulin lispro, sodium oxybate, olmesartan, and esomeprazole, were independent risk factors.
- The predictive model for drug-related IGE risk achieved an ROC-AUC of 0.739.
Why It Matters
This study provides crucial real-world evidence for clinicians, especially anesthesiologists, to optimize perioperative patient management. Early recognition of drug-related IGE is now better supported, allowing for more informed anesthetic plans and personalized fasting strategies. For individuals using GLP-1RAs or other identified medications, understanding these risk factors can prompt discussions with healthcare providers regarding potential IGE, particularly before procedures requiring fasting. This data highlights the importance of considering patient demographics and medication lists when assessing aspiration risk, potentially leading to safer patient outcomes and refined clinical protocols.
impaired-gastric-emptying
glp-1ra
semaglutide
tirzepatide
dulaglutide
exenatide