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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Pharmacology of Anti-Cancer Drugs
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1407709

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for sunitinib

Provisionally accepted
Xusheng Zhang Xusheng Zhang 1Xiuli Ren Xiuli Ren 2*Tianyu Zhu Tianyu Zhu 3*Wanjin Zheng Wanjin Zheng 4*Chengwu Shen Chengwu Shen 2*Cuicui Lu Cuicui Lu 1
  • 1 Department of Pharmacy, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong Province, China
  • 2 Department of pharmacology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China,, Jinan, China
  • 3 Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China
  • 4 Department of pharmacology, Hospital for Skin Diseases, Shandong First Medical University, Jinan, China,, Jinan, China

The final, formatted version of the article will be published soon.

    Background: Sunitinib is approved for the treatment of metastatic renal cell carcinoma (mRCC), imatinib-resistant gastrointestinal stromal tumors (GIST), and advanced pancreatic neuroendocrine tumors (PNET). This study aims to investigate the safety profiles of sunitinib through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: The individual case safety reports (ICSRs) on sunitinib from 2006 Q1 to 2024 Q1 were collected from the ASCII data packages in the Food and Drug Administration Adverse Event Reporting System (FAERS). After standardizing the data, a variety of disproportionality analyses, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the bayesian confidence propagation neural network (BCPNN), and the multi-item gamma poisson shrinker (MGPS) were employed to identify the potential safety signals of sunitinib-associated AEs. Results: A total of 35,923 ICSRs of sunitinib as the “primary suspected” drug were identified within the reporting period. The search detected 276 disproportionate preferred terms (PTs). The most common AEs, including diarrhea, asthenia, decreased appetite, hypertension, and dysgeusia, were consistent with the drug label and clinical trials. Unexpected significant AEs, such as uveal melanocytic proliferation, salivary gland fistula, yellow skin, eyelash discoloration, scrotal inflammation, were detected. The median onset time of sunitinib-related AEs was 57 days (interquartile range [IQR]16-170 days), with most of the ICSRs developing within the first month (n= 4582, 39.73%) after sunitinib therapy as initiated. Conclusion: The results of our study were consistent with routine clinical observations, and some unexpected AEs signals were also identified for sunitinib, providing valuable evidence for the safe use of sunitinib in the real-world and contributing to the clinical monitoring and risk identification of sunitinib.

    Keywords: Sunitinib, FDA Adverse Event Reporting System, disproportionality analyses, Pharmacovigilance, Adverse event

    Received: 27 Mar 2024; Accepted: 12 Jul 2024.

    Copyright: © 2024 Zhang, Ren, Zhu, Zheng, Shen and Lu. 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:
    Xiuli Ren, Department of pharmacology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China,, Jinan, China
    Tianyu Zhu, Cheeloo College of Medicine, Shandong University, Jinan, 250012, Shandong, China
    Wanjin Zheng, Department of pharmacology, Hospital for Skin Diseases, Shandong First Medical University, Jinan, China,, Jinan, China
    Chengwu Shen, Department of pharmacology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China,, Jinan, 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.