Yang Nan, Han Xiang, Hua Hongning, Wang Yumeng, Chen Yulin, Zhou Yue, Feng Haoyu
Third Hospital of Shanxi Medical University, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Taiyuan, China.
Xinqiao Hospital ARMY Medical University, Chongqing, China.
Front Pharmacol. 2025 Oct 13;16:1685289. doi: 10.3389/fphar.2025.1685289. eCollection 2025.
Controversy remains regarding the association between antiepileptic drugs and osteopenia, and this study aims to investigate and address this gap using real-world data.
This study included data from the United States (U.S.) Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter of 2005 to the first quarter of 2025. A disproportionate analysis method and Bonferroni-corrected p-value were used to detect association signals between antiepileptic drugs and osteopenia. Additionally, subgroup analyses were conducted to explore differences among different age and gender groups.
Among the 206,680 adverse events associated with 12 commonly used antiepileptic drugs recorded in the FAERS database during the study period, 181 were attributable to osteopenia. Positive drug safety signals were detected for phenytoin, valproic acid, gabapentin, and eslicarbazepine.
Previous studies have only identified a link between phenytoin and osteopenia, while the relationship between valproic acid and this adverse event remains controversial, and gabapentin and eslicarbazepine have not been systematically reported. The findings provide the first evidence of an association between these four antiepileptic drugs and osteopenia, offering insights and guidance for clinical recognition and prevention of such events.
抗癫痫药物与骨质减少之间的关联仍存在争议，本研究旨在利用真实世界数据调查并填补这一空白。
本研究纳入了美国食品药品监督管理局不良事件报告系统（FAERS）2005年第一季度至2025年第一季度的数据。采用不成比例分析方法和经Bonferroni校正的p值来检测抗癫痫药物与骨质减少之间的关联信号。此外，还进行了亚组分析以探讨不同年龄和性别组之间的差异。
在研究期间FAERS数据库中记录的与12种常用抗癫痫药物相关的206,680例不良事件中，有181例归因于骨质减少。苯妥英、丙戊酸、加巴喷丁和依斯立carbazepine检测到阳性药物安全信号。
既往研究仅发现苯妥英与骨质减少之间存在关联，而丙戊酸与这一不良事件之间的关系仍存在争议，加巴喷丁和依斯立carbazepine尚未得到系统报道。这些发现首次证明了这四种抗癫痫药物与骨质减少之间的关联，为临床识别和预防此类事件提供了见解和指导。
