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An Updated Comprehensive Pharmacovigilance Study of Drug- Induced Breast Cancer Based on FDA Adverse Event Reporting
Ziran Qiu1, Xinyu Liu2, Wenqing Cao1
1Department of Breast and Thyroid Surgery, Loudi Central Hospital, Loudi, 417000, China.
Current Medicinal Chemistry
|January 9, 2026
Summary
This study analyzed FDA adverse event reports to identify breast cancer drug risks. Certain therapies like lapatinib and trastuzumab showed higher adverse event reporting, highlighting the need for careful monitoring and personalized treatment decisions.
Area of Science:
- Oncology
- Pharmacovigilance
- Drug Safety
Background:
- Understanding drug-specific risk profiles in breast cancer (BC) treatment is crucial for regulatory and clinical decision-making.
- Existing knowledge gaps necessitate comprehensive analysis of adverse event data.
Purpose of the Study:
- To analyze the FDA's Adverse Event Reporting System (FAERS) database for breast cancer (BC) drug safety.
- To identify specific drugs associated with a higher proportion of adverse event reports and assess their risk profiles.
Main Methods:
- Retrospective study using FAERS data (2004-2024).
- Data cleaning, drug name standardization.
- Statistical analysis including proportional imbalance and Reporting Odds Ratio (ROR).
Main Results:
- Significant differences in adverse reaction reports among BC drugs were identified.
- Trastuzumab, lapatinib, and certain endocrine therapies showed higher adverse event reports and ROR values.
- Cardiotoxicity, osteoporosis, ovarian function impairment, and immune complications are key adverse reactions.
Conclusions:
- FAERS data analysis reveals significant variations in drug-induced adverse events in BC therapies.
- Targeted therapies (lapatinib, fulvestrant, letrozole, ribociclib) and HER2-positive BC treatments (trastuzumab) require vigilant monitoring.
- Personalized risk-benefit assessments are essential for BC patients based on distinct drug risk profiles.
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