Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Sci Rep. 2024 Oct 9;14(1):23624. doi: 10.1038/s41598-024-74744-3.
Congenital anomalies of the external ear can have a significant impact on a child's development and quality of life. While genetic factors play a crucial role in the etiology of these anomalies, environmental factors such as drug exposure during pregnancy may also contribute to their occurrence. This study aims to investigate the association between drug exposure and congenital anomalies of the external ear using data from an adverse drug reaction report database. Using OpenVigil 2.1, we queried the FAERS database to retrieve adverse event reports from the first quarter of 2004 to the first quarter of 2024. To identify relevant cases, we used Medical Dictionary for Regulatory Activities terms focusing on congenital anomalies of the external ear. Drug generic names were sourced from the DrugBank database. To assess safety signals and rank drugs by their signal strength, we conducted a disproportionality analysis, generating reporting odds ratios (ROR) and proportional reporting ratios (PRR). A total of 20,754,281 AE reports were identified in the FAERS database from Q1 2004 to Q1 2024, of which 1763 were related to congenital anomalies of the external ear. Valproic acid (122 cases) was associated with the most cases, followed by mycophenolate mofetil (105 cases) and lamotrigine (65 cases). According to the disproportionality analysis, the top five drugs with the highest ROR and PRR were primidone (ROR: 397.05, 95% CI 147.21, 1070.9; PRR: 388.71, 95% CI 145.89, 1035.7), valproic acid (ROR: 239.46, 95% CI 123.75, 463.37; PRR: 236.42, 95% CI 123.82, 451.43), tapazole (ROR: 198.35, 95% CI 63.49, 619.67; PRR: 196.25, 95% CI 62.97, 611.67), nevirapine (ROR: 138.24, 95% CI 82.9, 230.51; PRR: 137.23, 95% CI 82.44, 228.44), and sebivo (ROR: 117.1, 95% CI 48.51, 282.67; PRR: 116.37, 95% CI 48.17, 281.12). This study identified several drugs significantly associated with congenital anomalies of the external ear in the FAERS database using disproportionality analysis. The findings can help healthcare professionals better recognize and manage drug-induced congenital anomalies of the external ear, particularly when prescribing high-risk medications. Further research is needed to elucidate the mechanisms underlying these associations and develop strategies for preventing and mitigating drug-induced congenital anomalies of the external ear.
先天性外耳畸形可能对外耳的发育和生活质量产生重大影响。虽然遗传因素在外耳畸形的病因学中起着关键作用，但药物暴露等环境因素也可能导致其发生。本研究旨在使用不良药物反应报告数据库中的数据，调查药物暴露与先天性外耳畸形之间的关联。使用 OpenVigil 2.1，我们从 FAERS 数据库中查询了 2004 年第一季度至 2024 年第一季度的不良事件报告。为了确定相关病例，我们使用了重点关注先天性外耳畸形的监管活动医学词典术语。药物通用名称来自 DrugBank 数据库。为了评估安全信号并根据信号强度对药物进行排名，我们进行了不相称性分析，生成报告比值比 (ROR) 和比例报告比值 (PRR)。从 2004 年第一季度到 2024 年第一季度，我们从 FAERS 数据库中确定了 20,754,281 份 AE 报告，其中 1763 份与先天性外耳畸形有关。丙戊酸（122 例）与最多的病例相关，其次是霉酚酸酯（105 例）和拉莫三嗪（65 例）。根据不相称性分析，ROR 和 PRR 最高的前五名药物分别为扑米酮（ROR：397.05，95%CI 147.21，1070.9；PRR：388.71，95%CI 145.89，1035.7）、丙戊酸（ROR：239.46，95%CI 123.75，463.37；PRR：236.42，95%CI 123.82，451.43）、他巴唑（ROR：198.35，95%CI 63.49，619.67；PRR：196.25，95%CI 62.97，611.67）、奈韦拉平（ROR：138.24，95%CI 82.9，230.51；PRR：137.23，95%CI 82.44，228.44）和 Sebivo（ROR：117.1，95%CI 48.51，282.67；PRR：116.37，95%CI 48.17，281.12）。本研究使用不相称性分析在 FAERS 数据库中确定了几种与先天性外耳畸形显著相关的药物。这些发现可以帮助医疗保健专业人员更好地识别和管理药物引起的先天性外耳畸形，特别是在开处方高风险药物时。需要进一步研究阐明这些关联的机制，并制定预防和减轻药物引起的先天性外耳畸形的策略。
