Xu Lisi, Zhang Ruonan, Zhang Xiaolin, Shang Xiuli, Huang Daifa
Department of the Second Cadre Ward, General Hospital of Northern Theater Command, Shenyang, China.
Department of Neurology, The First Affiliated Hospital of China Medical University, Shenyang, China.
Ther Adv Neurol Disord. 2025 Jan 28;18:17562864251315137. doi: 10.1177/17562864251315137. eCollection 2025.
Dementia is a serious adverse event (AE) that requires attention in clinical practice. However, information on drug-induced dementia is limited. The U.S. FDA Adverse Event Reporting System (FAERS) serves as an important resource for identifying real-world adverse drug reactions and safety signals.
This study aimed to use FAERS data to identify drugs associated with increased dementia risk.
A secondary analysis of the FAERS database was conducted using disproportionality analysis methods.
We reviewed dementia-related reports in the FAERS database from the first quarter of 2004 to the fourth quarter of 2023, used the Medical Dictionary for Regulatory Activity to identify dementia cases and summarized the corresponding list of potential medications, counted the dementia-causing medication classes with the highest frequency of reports, and disaggregated all medications.
The study identified 31,881 dementia-related AEs in the FAERS database, with an increasing trend over time, particularly among females and individuals over 65. Apixaban had the most reports (1631). Disproportionality analyses revealed that rivastigmine, nicergoline, aducanumab, amlodipine/atorvastatin, and dihydroergometrine had the highest risk, based on reporting odds ratio, proportional reporting ratio, and information component. Only valproate and tramadol among the top 50 drugs included a potential dementia risk in their package inserts.
This study identified a list of medications associated with dementia risk, many of which lack dementia warnings on their labels. Increased monitoring is necessary for high-risk individuals, and further research is required to clarify these associations and improve patient safety.
痴呆是一种严重的不良事件（AE），在临床实践中需要引起关注。然而，关于药物性痴呆的信息有限。美国食品药品监督管理局不良事件报告系统（FAERS）是识别现实世界中药物不良反应和安全信号的重要资源。
本研究旨在利用FAERS数据识别与痴呆风险增加相关的药物。
使用不成比例分析方法对FAERS数据库进行二次分析。
我们回顾了FAERS数据库中2004年第一季度至2023年第四季度与痴呆相关的报告，使用《监管活动医学词典》识别痴呆病例并汇总相应的潜在药物清单，统计报告频率最高的导致痴呆的药物类别，并对所有药物进行分类。
该研究在FAERS数据库中识别出31881例与痴呆相关的不良事件，且随时间呈上升趋势，在女性和65岁以上人群中尤为明显。阿哌沙班的报告最多（1631例）。不成比例分析显示，基于报告比值比、比例报告比和信息成分，卡巴拉汀、尼麦角林、阿杜卡努单抗、氨氯地平/阿托伐他汀和双氢麦角碱的风险最高。在前50种药物中，只有丙戊酸盐和曲马多在其包装说明书中包含潜在的痴呆风险。
本研究确定了一份与痴呆风险相关的药物清单，其中许多药物标签上缺乏痴呆警告。对高危个体有必要加强监测，还需要进一步研究以阐明这些关联并提高患者安全性。
