A Real-World Pharmacovigilance Study of Fruquintinib Based on the FDA Adverse Event Reporting System (FAERS) Database
Yajing Xu1, Dongchen Wang2, Yuyan Xu3
1Department of Radiation Oncology, Wenzhou Central Hospital, Wenzhou, China.
Background:
Fruquintinib is a highly selective small-molecule inhibitor that targets vascular endothelial growth factor receptors and is approved for the treatment of metastatic colorectal cancer. Given its increasing clinical adoption, a comprehensive pharmacovigilance evaluation of the adverse events (AEs) is warranted.
Methods:
We conducted an analysis of fruquintinib-related AEs by mining the FDA Adverse Event Reporting System (FAERS) database, covering the period from the fourth quarter of 2023 to the first quarter of 2025. The regulatory characterization of the AEs was based on the system organ class (SOC) and preferred term (PT) of the Medical Dictionary for Regulatory Activities (MedDRA). We employed four disproportionality analysis methods, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), multi-item gamma Poisson shrinker (MGPS), and Bayesian confidence propagation neural network (BCPNN). Furthermore, Weibull distribution modeling was employed to characterize the temporal risk patterns of adverse reactions.
Results:
Among 1632 reports in which fruquintinib was flagged as the primary suspect drug, 78 PTs met the criteria of all four algorithms. In addition to known AEs listed on the drug label, the analysis also identified previously unrecognized AEs, encompassing large intestinal obstruction, dehydration, peripheral neuropathy, renal-limited thrombotic microangiopathy, and posterior reversible encephalopathy syndrome. The median onset time of fruquintinib-associated AEs was 18 days, with 66.16% of cases occurring within the first month of treatment.
Conclusion:
This pharmacovigilance study aligned with established clinical observations. Additionally, novel AEs associated with fruquintinib therapy were detected, offering valuable evidence to enhance clinical surveillance strategies and risk assessment protocols.
Insights
This study identified new adverse events (AEs) associated with fruquintinib, a colorectal cancer drug, in post-market surveillance. Early detection of these fruquintinib AEs can improve patient safety and treatment strategies.
Area of Science:
- Pharmacovigilance and Drug Safety
- Oncology Therapeutics
- Regulatory Science
Background:
- Fruquintinib is an approved small-molecule inhibitor targeting vascular endothelial growth factor receptors for metastatic colorectal cancer.
- Increasing clinical use necessitates comprehensive pharmacovigilance for adverse events (AEs).
Purpose of the Study:
- To conduct a pharmacovigilance evaluation of fruquintinib-related adverse events.
- To identify novel AEs and characterize temporal risk patterns.
Main Methods:
- Analysis of FDA Adverse Event Reporting System (FAERS) database from Q4 2023 to Q1 2025.
- Utilized four disproportionality analysis methods (ROR, PRR, MGPS, BCPNN) and Weibull distribution modeling.
- Characterized AEs using Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) and preferred term (PT).
Main Results:
- 1632 reports analyzed; 78 PTs met criteria for all four algorithms.
- Identified previously unrecognized AEs: large intestinal obstruction, dehydration, peripheral neuropathy, renal-limited thrombotic microangiopathy, and posterior reversible encephalopathy syndrome.
- Median AE onset was 18 days, with 66.16% occurring within the first month.
Conclusions:
- Study findings align with known clinical observations of fruquintinib.
- Novel AEs associated with fruquintinib were detected, enhancing clinical surveillance and risk assessment.
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