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.