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

作者：Jinfeng Liu, Junyi Tan, Qinli Xiao, Yingtao Bai, En Chang, Chun Yan Su, Yuxun Wei, Zhong Hu, Wei Wei · 发表于：Frontiers in Pharmacology · 年份：2025 · DOI：10.3389/fphar.2025.1532461 · 被引用次数：2 · 研究领域：Hearing, Cochlea, Tinnitus, Genetics、Pharmaceutical studies and practices、Blood disorders and treatments

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 vincr...