Post-marketing signal detection of fruquintinib-associated adverse events using the FAERS database

Clinical Snapshot

Key Findings

• P Value: Statistically significant signals identified but specific p-values not provided

• Effect Size: Bone marrow suppression (ROR = 11.17), peripheral neuropathy (ROR = 4.24), dehydration (ROR = 3.98)

• Primary Outcome: 92 statistically significant safety signals identified from fruquintinib reports

• Nnt Or Sensitivity: Signal detection sensitivity enhanced through multi-algorithm approach using PRR, BCPNN, and ROR

• Confidence Interval: Not reported in abstract

Clinical Application

Findings support enhanced monitoring for bone marrow suppression, neuropathy, and dehydration in clinical practice Relevant for Australian oncologists; fruquintinib not currently PBS-listed but safety data applicable if future access established through Special Access Scheme or clinical trials Oncology patients receiving fruquintinib, particularly those with metastatic colorectal cancer

Abstract

Fruquintinib, a targeted therapeutic agent approved in 2018 for the treatment of metastatic colorectal cancer, is gradually being applied in an expanding range of clinical settings. Given the complexities associated with real-world dosing, a comprehensive evaluation of its safety profile is essential for optimizing clinical decision-making. We conducted a retrospective pharmacovigilance study utilizing a spontaneous reporting system. Reports related to Fruquintinib were extracted through a standardized data cleaning process and cross-validated using 3 complementary signal detection algorithms: proportional reporting ratio, Bayesian confidence propagation neural network, and reporting odds ratio (ROR). This approach was employed to systematically assess the drug's safety and identify potential adverse event signals. A total of 92 statistically significant safety signals were identified from 1188 independent cases included in the analysis, corresponding to 1836 adverse event reports. The signal distribution exhibited organ system specificity, with gastrointestinal reactions being the most prevalent category. These reactions primarily manifested as typical drug-related toxicities, including diarrhea and nausea. Other notable complications included neurological, respiratory, dermatological, renal, and cardiovascular events. Important aes not mentioned in the instructions, such as bone marrow suppression (ROR = 11.17), peripheral neuropathy (ROR = 4.24) and dehydration (ROR = 3.98), were also discovered. This study systematically characterizes the post-marketing safety profile of Fruquintinib through a multi-algorithm synergistic analysis, confirming that its safety profile aligns with the clinically expected outcomes based on its mechanism of action. Future research should focus on analyzing drug interaction mechanisms and exploring biomarkers to develop a precise risk-benefit assessment model.

References

1. 1.Liu, Cui, Zhang, Hao. (2024). Post-marketing signal detection of fruquintinib-associated adverse events using the FAERS database. Medicine, Article 0000000000048239. https://doi.org/10.1097/MD.0000000000048239