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. 2025 Jun 26:16:1532461.
doi: 10.3389/fphar.2025.1532461. eCollection 2025.

Drug-associated hearing impairment in children: a disproportionality analysis of the FDA adverse event reporting system

Jinfeng Liu  1 , Junyi Tan  1 , Qinli Xiao  2 , Yingtao Bai  1 , En Chang  1 , Chun Su  1 , Yuxun Wei  1 , Hu Zhong  1 , Wei Wei  1
Affiliations

Drug-associated hearing impairment in children: a disproportionality analysis of the FDA adverse event reporting system

Jinfeng Liu et al. Front Pharmacol. .

Abstract

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.

Methods: 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.

Results: 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, ROR = 73.59 (20.24-267.63)], and amikacin [N = 11 cases, ROR = 71.31 (36.40-139.72)]. The top 3 drugs with the highest number of reports were carboplatin [N = 125 cases, ROR = 18.41 (15.27-22.21)], cisplatin [N = 78 cases, ROR = 31.24 (24.59-39.70)], and vincristine [N = 56 cases, ROR = 6.32 (4.83-8.27)]. Based on drug labeling, 48% drugs (27/56) were classified as potentially ototoxic.

Conclusion: 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: FAERS; children; disproportionality; drug-associated hearing impairment; pharmacovigilance.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
Drugs related to hearing impairment in children based on ROR.
See this image and copyright information in PMC

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