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ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Gastrointestinal and Hepatic Pharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1469597
A Real-World Disproportionality Analysis of Ripretinib Data Mining of the Public Version of FDA Adverse Event Reporting System
Provisionally accepted- 1 Qingdao Municipal Hospital, Qingdao, China
- 2 The First Hospital of Jilin University, changchun, China
Background: Tyrosine kinase inhibitors (TKIs) are the preferred targeted therapy for advanced gastrointestinal stromal tumors (GIST). Ripretinib, the first tyrosine kinase switch control inhibitor,has not yet been extensively studied for long-term safety in large populations. This study evaluates Ripretinib-related adverse events (AEs) in real-world applications by analyzing data from the FDA's Adverse Event Reporting System (FAERS).: To quantify signals of AEs, we employed several disproportionality analyses: the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).Results: In the FAERS database, out of 7,064,646 reports, 3,161 were identified as related to Ripretinib AEs, with 438 significant disproportionality in preferred terms. The most common adverse reactions were tiredness, hair loss, nausea, constipation, diarrhea, loss of appetite, palmar-plantar erythrodysesthesia syndrome, and vomiting. These reactions align with the medication instructions and reports from corresponding clinical trials. Notably, the label includes unexpected and significant AEs such as "hepatic neoplasm", "hair texture abnormal", "metastases to liver" and "red blood cell count decreased". The median onset time for Ripretinib-related AEs was 99 days, with an interquartile range of 27 to 245 days. Most cases (26.74%, n=165) occurred within the first month of Ripretinib administration. Conclusion: Our findings align with clinical observations. We identified novel and unexpected AEs signatures of Ripretinib, indicating that prospective clinical studies are necessary to confirm these findings and clarify their implications. These results could provide valuable evidence to guide further safety studies on Ripretinib.
Keywords: FAERS, ripretinib, adverse events, Gastrointestinal Stromal Tumor, Pharmacovigilance
Received: 24 Jul 2024; Accepted: 03 Mar 2025.
Copyright: © 2025 Feng, Fa, Wang, Zhang, Sun and Li. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Xuan Sun, The First Hospital of Jilin University, changchun, China
Faping Li, The First Hospital of Jilin University, changchun, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.