Drug-induced upper gastrointestinal bleeding: A real-world pharmacovigilance study - PubMed
5 hours ago
- #pharmacovigilance
- #gastrointestinal-bleeding
- #drug-safety
- Study focuses on drug-induced upper gastrointestinal bleeding (UGIB) using real-world pharmacovigilance data.
- Data sourced from FAERS and JADER databases (2004-2024 Q2), analyzing top 50 drugs by frequency.
- Four signal detection methods used: Reporting Odds Ratio, Proportional Reporting Ratio, Empirical Bayes Geometric Mean, Bayesian Confidence Propagation Neural Network.
- Total UGIB reports: 62,941 (FAERS: 57,414; JADER: 5,527).
- Aspirin ranked top 5 in both databases for frequency and signal strength.
- FAERS high-report drugs: Rivaroxaban, warfarin, pradaxa (high signal values).
- JADER high-report drugs: Clopidogrel, loxoprofen, apixaban, bevacizumab; esflurbiprofen/mentha oil and lornoxicam had extreme signal values.
- Meloxicam and prasugrel also showed elevated signal values.
- Study identifies common and database-specific risk drugs, providing quantitative risk assessment for clinical safety decisions.
- Open-access article under Creative Commons License; no conflicts declared.