An Updated Comprehensive Pharmacovigilance Study of Drug- Induced Breast Cancer Based on FDA Adverse Event Reporting System Data.

[INTRODUCTION] To address critical knowledge gaps in understanding drug-specific risk profiles of breast cancer (BC), ultimately informing regulatory decision-making and clinical practice.

[METHODS] This study conducted a retrospective drug safety study based on the FDA's Adverse Event Reporting System (FAERS) database, examining BC drug treatment data from 2004 to 2024. The research involved data cleaning, standardization of drug names, and the application of statistical analysis methods such as the proportional imbalance method and the Reporting Odds Ratio (ROR) to assess potential associations between drugs and adverse events.

[RESULTS] Significant differences were determined in adverse reaction reports among different drugs in BC treatment. Specific drugs such as trastuzumab, lapatinib, and certain endocrine therapy medications accounted for a higher proportion of adverse event reports and exhibited higher ROR values. Additionally, the study identified that cardiotoxicity, osteoporosis, ovarian function impairment, and immune complications are adverse reactions requiring special attention in BC drug treatment.

[DISCUSSION] This comprehensive analysis of FAERS data highlights the significance in drug-induced adverse event reporting across BC therapies. This work promotes the advancement of patient safety by providing actionable evidence for therapeutic decision making in the oncology of BC. A limitation of this study is the lack of integration of potential mechanisms for adverse events in BC patients.

[CONCLUSION] Targeted therapies of lapatinib, fulvestrant, and endocrine agents (letrozole or ribociclib) show disproportionately high AE reporting odds ratios, necessitating vigilant monitoring. HER2-positive BC treatments (trastuzumab) and TNBC agents (sonidegib) exhibit distinct risk profiles, advocating for personalized risk-benefit assessments for BC patients.