Hepatotoxicity associated with anti-neoplastic agents: a pharmacovigilance analysis of the Food and Drug Administration Adverse Event Reporting System database
This analysis profiles hepatotoxicity signals for anti-neoplastic agents but reveals a major methodological gap: without using a validated causality tool like the updated RUCAM, FAERS data cannot confirm druginduced liver injury (DILI). Future studies should integrate RUCAM to improvespecificity and clinical relevance.
Authors
- Lei Shi (ORCID: https://orcid.org/0000-0003-2627-7588)
- Ying Qu (ORCID: https://orcid.org/0000-0002-5750-9241)
- Rong Chen (ORCID: https://orcid.org/0009-0000-3339-7233)
- Shilong Wang (ORCID: https://orcid.org/0000-0001-6086-0481)
Institutions
- Soochow University (CN)
- The First People's Hospital of Changzhou (CN)
- Changzhou Third People's Hospital (CN)
- Nanjing Medical University (CN)
Publication Details
- Journal
- Frontiers in Immunology
- Published
- 2025-12-19
- DOI
- https://doi.org/10.3389/fimmu.2025.1665425
- Primary Topic
- Pharmacovigilance and Adverse Drug Reactions
- Type
- article
- Field-Weighted Citation Impact
- 0.00