ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Pharmacoepidemiology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1532461
Drug-associated hearing impairment in children: a disproportionality analysis of the FDA Adverse Event Reporting System
Provisionally accepted
- 1Department of Pharmacy, People's Hospital of Zhongjiang County, Deyang, China
- 2Department of rehabilitation, People's Hospital of Zhongjiang County, Deyang, China
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Objective: Drug-associated hearing impairment has a serious impact on children's quality of life and poses a significant public health burden. However, there is a lack of large-scale population-based studies of medication-associated hearing impairment in children. The aim of this study was to hypothesize about medications through data mining in order to assess the potential risk of these medications increasing hearing impairment in children.We extracted and analyzed reports on drugs linked to hearing impairment in children from the FDA Adverse Event Reporting System (FAERS). To assess the relationship between drugs and hearing impairment in children, we performed a disproportionality study utilizing the proportional reporting ratio (PRR) and reporting odds ratio (ROR). Concurrently, we conducted comparisons with medicine labels to identify medications that, although not now indicating hearing impairment in their labels, may possibly pose risks of hearing impairment in children.: In the FAERS database, there are 1,884 reports of AE related to hearing impairment in children. The top three medications with the highest ROR were vinblastin [N=6 cases, ROR=86.72 (34.15-220.19)], risedronate [N=3 cases, ], and amikacin [N=11 cases,]. The top 3 drugs with the highest number of reports were carboplatin [N=125 cases,], cisplatin [N=78 cases, ROR=31.24 (24.59-39.70)],and vincristine [N=56 cases,]. Based on drug labeling, 48% drugs (27/56) were classified as potentially ototoxic.Approximately 48% of the 56 medications with possible safety signals for hearing loss that were included in our analysis did not have hearing impairment mentioned as a side effect on their labels for children's medications. Our findings suggest that nearly half of the 56 drugs linked to hearing impairment signals in children are not currently labeled with ototoxicity warnings. Consequently, further research is required to evaluate the association of these medicines with this risk.
Keywords: Drug-associated hearing impairment, Children, Disproportionality, FAERS, Pharmacovigilance
Received: 22 Nov 2024; Accepted: 19 Jun 2025.
Copyright: © 2025 Liu, Tan, Xiao, Bai, Chang, Su, Wei, Zhong and Wei. 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: Wei Wei, Department of Pharmacy, People's Hospital of Zhongjiang County, Deyang, 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.