Li Baojian, Hu Xiaoling, Yue Zichen
Department of Pharmacy, Heping Hospital Affiliated to Changzhi Medical College, Changzhi, China.
Front Pharmacol. 2024 Nov 22;15:1480994. doi: 10.3389/fphar.2024.1480994. eCollection 2024.
To evaluate and identify reports of adverse events related to hearing impairment with drugs approved in the past 20 years, to identify new adverse reaction signals related to hearing impairment that have not yet been reported, and to improve the safety of drug treatments.
The adverse event report data from the FAERS database from the first quarter of 2004 to the fourth quarter of 2023 were retrieved. "Hearing disorders" was used as the keyword to screen for drugs related to the adverse event. After standardizing the drug name and the adverse drug event name, the adverse event reports with hearing disorders as the main suspect were collected, and the proportional imbalance algorithm was used to detect the potential adverse event signals to drug-related hearing impairment.
The top five drugs with the highest number of reported adverse events to hearing impairment were sacubitril/valsartan (2,674), adalimumab (2,479), etanercept (1,834), tofacitinib (1,812), and apixaban (1,600). Except for adalimumab, the risk of hearing impairment is not mentioned in the instructions. The top five drugs for new signal strength are pancuronium ( = 13, ROR 67.57, PRR 53.61, IC5.74, EBGM 53.06), paromomycin ( = 6, ROR 46.3, PRR 39.33, IC5.30, EBGM 39.33), tafamidis ( = 300, ROR 14.90, PRR 14.13, IC3.82, EBGM 14.07), vildagliptin/metformin ( = 83, ROR 11.47, PRR 11.02, IC3.46, EBGM 11.01), and atorvastatin calcium/ezetimibe ( = 6, ROR 10.76, PRR 10.36, IC3.37, EBGM 10.36).
Our study covered 20 years of real-world data on reports of adverse events related to hearing impairment in the FAERS database, validating previous reports and studies, as well as identifying drugs that signal new adverse events of hearing impairment, especially some drugs commonly used for the treatment of chronic diseases (a combination of hypoglycemic drugs, antihypertensive drugs, and lipid modulators) and some new drugs in the 5-year post-market period.
评估并识别过去20年获批药物中与听力损害相关的不良事件报告，识别尚未报告的与听力损害相关的新不良反应信号，提高药物治疗的安全性。
检索2004年第一季度至2023年第四季度FAERS数据库中的不良事件报告数据。以“听力障碍”作为关键词筛选与该不良事件相关的药物。在对药物名称和药品不良事件名称进行标准化后，收集以听力障碍为主要怀疑对象的不良事件报告，并使用比例失衡算法检测与药物相关听力损害的潜在不良事件信号。
报告听力损害不良事件数量最多的前五种药物为沙库巴曲缬沙坦（2674例）、阿达木单抗（2479例）、依那西普（1834例）、托法替布（1812例）和阿哌沙班（1600例）。除阿达木单抗外，说明书中未提及听力损害风险。新信号强度排名前五的药物为泮库溴铵（=13，ROR 67.57，PRR 53.61，IC5.74，EBGM 53.06）、巴龙霉素（=6，ROR 46.3，PRR 39.33，IC5.30，EBGM 39.33）、塔非酰胺（=300，ROR 14.90，PRR 14.13，IC3.82，EBGM 14.07）、维格列汀/二甲双胍（=83，ROR 11.47，PRR 11.02，IC3.46，EBGM 11.01）和阿托伐他汀钙/依折麦布（=6，ROR 10.76，PRR 10.36，IC3.37，EBGM 10.36）。
我们的研究涵盖了FAERS数据库中20年关于听力损害不良事件报告的真实世界数据，验证了既往报告和研究，同时识别出提示听力损害新不良事件的药物，尤其是一些常用于治疗慢性病的药物（降糖药、降压药和调脂药的组合）以及上市后5年内的一些新药。
