Drug-induced upper gastrointestinal bleeding: A real-world pharmacovigilance study

Area of Science:

• Pharmacovigilance and Drug Safety Research
• Real-world Evidence in Adverse Drug Reaction Monitoring
• Quantitative Risk Assessment of Medications

Background:

• Drug-induced upper gastrointestinal bleeding (UGIB) is a significant adverse event requiring vigilant monitoring.
• Real-world pharmacovigilance is crucial for understanding drug safety and preventing potential risks.
• Existing research highlights the need for enhanced drug safety surveillance.

Purpose of the Study:

• To conduct a real-world pharmacovigilance study on drug-induced UGIB.
• To identify and assess the risk profiles of frequently reported drugs associated with UGIB.
• To provide evidence for improving clinical medication safety decision-making.

Main Methods:

• Utilized data from the Food and Drug Administration Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER) databases (2004-2024).
• Applied four signal detection methods: Reporting Odds Ratio, Proportional Reporting Ratio, Empirical Bayes Geometric Mean, and Bayesian Confidence Propagation Neural Network.
• Focused on the top 50 drugs with higher reported frequencies of UGIB.

Main Results:

• Analyzed 62,941 UGIB reports (57,414 from FAERS, 5,527 from JADER).
• Aspirin showed high frequency and signal strength in both databases.
• Rivaroxaban, warfarin, and pradaxa were top-risk drugs in FAERS; clopidogrel, loxoprofen, apixaban, and bevacizumab in JADER, with some exhibiting extremely high signal values.

Conclusions:

• Integrated analysis of FAERS and JADER identified common and database-specific drugs associated with UGIB risk.
• Systematic quantitative risk assessment was performed on high-frequency reporting drugs.
• Findings enhance understanding of drug risk profiles and offer critical evidence for clinical medication safety.