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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Drugs Outcomes Research and Policies
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1425171
This article is part of the Research Topic The role of validated tools, including pictorial aids, to support medication adherence and counselling View all 6 articles

Neratinib safety evaluation: Real-world adverse event analysis from the FAERS database

Provisionally accepted
Xiushan Dong Xiushan Dong 1*Yunhe Fan Yunhe Fan 2Teng Wu Teng Wu 2Pengyang Xu Pengyang Xu 2Chuanli Yang Chuanli Yang 2Jie An Jie An 2Haijia Zhang Haijia Zhang 2Mureed Abbas Mureed Abbas 3
  • 1 Shanxi Bethune Hospital, Shanxi Medical University, Taiyuan, China
  • 2 Department of General Surgery, Shanxi Bethune Hospital, Shanxi Medical University, Taiyuan, Shanxi Province, China
  • 3 Key Laboratory of Chemical Biology and Molecular Engineering of Ministry of Education, Shanxi University, Taiyuan, Shanxi Province, China

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

    Aims: Neratinib has emerged as significant theraputic option for breast cancer treatment. However, despite its approval, numerous adverse drug events (ADEs) associated to it remain unrecognized and unreported. This study aims to mine and analyze the signals of ADEs related to neratinib from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database, providing insights for safe and rational clinical use of drug.Methods: All the neratinib-related ADEs data were collected from FAERS database from the third quarter (Q3) of 2017 to the fourth quarter (Q4) of 2023. After standardizing the data, 4 disproportionality methods were used to assess the correlation between neratinib and ADEs.Of the 1,544 ADEs implicating neratinib as the primary suspected drug, a combined total of 48 preferred terms (PTs) and 10 system organ classes (SOCs) showed significant disproportionality accross all four algorithms simultaneously.These SOCs included gastrointestinal disorders (n=2564, ROR 7.14), general disorders and administration site conditions (n=958, ROR 0.77) and injury poisoning and procedural complications (n=474, ROR 0.58) among others. Upon comparison with the neratinib manual, 34 ADEs not documented in the manual were found at the PT level.Our study provide new real-world evidence for drug safety information of neratinib. While the majority of our findings were aligned with the information provided in the manual. We identified additional ADEs not previously documented.Consequently, further studies are needed to validate unreported ADEs to ensure the efficacy and safety of neratinib for patients.

    Keywords: Neratinib, FAERS, Adverse drug events, Disproportionality methods, safety signal

    Received: 29 Apr 2024; Accepted: 02 Sep 2024.

    Copyright: © 2024 Dong, Fan, Wu, Xu, Yang, An, Zhang and Abbas. 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: Xiushan Dong, Shanxi Bethune Hospital, Shanxi Medical University, Taiyuan, 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.