Signal detection of drug-induced esophageal ulcer across 20 years of real-world study: Focus on 49 high-risk medicines - PubMed
4 hours ago
- #pharmacovigilance
- #drug-induced esophageal ulcer
- #FDA Adverse Event Reporting System
- Study aimed to identify drug-induced esophageal ulcers and fill knowledge gaps using FDA Adverse Event Reporting System data from 2004 to 2024.
- Disproportionality analyses identified 49 high-risk drugs across nine therapeutic classes, including antineoplastics, immunomodulators, and systemic anti-infectives.
- Most frequently reported drugs were aspirin, alendronic acid, and doxycycline, with doxycycline, clindamycin, and alendronic acid showing the strongest safety signals.
- Antineoplastics/immunomodulators (Class L) had the highest cumulative risk, driven by tacrolimus, mycophenolic acid, and sunitinib.
- Tacrolimus, sunitinib, meclofenamic acid, clopidogrel, and erlotinib were linked to esophageal ulcers but are not labeled for this risk.
- Findings can guide safer prescribing, patient counseling, and targeted pharmacovigilance efforts.