Real-world pharmacovigilance assessment of hepatotoxicity risk with HER2-Targeted drugs using FAERS database analysis.

ABSTRACT: Human epidermal growth factor receptor 2 (HER2)-targeted therapies, including monoclonal antibodies (mAbs), small-molecule tyrosine kinase inhibitors (TKIs), and antibody-drug conjugates (ADCs), have significantly improved clinical outcomes in HER2-positive cancers. However, hepatotoxicity remains a major concern with these therapies, and a comprehensive analysis of the hepatotoxicity signals across different HER2-targeted drugs is lacking. We aim to conduct a comprehensive comparative analysis of hepatotoxicity risk related to various HER2-targeted agents. Real-world pharmacovigilance research was conducted on the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database from Q1 2012 to Q2 2024. Disproportionality analysis was used to assess the stre

SUBMITTER: Dong J 

PROVIDER: S-EPMC12328589 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature