A real-world data analysis of acetylsalicylic acid in FDA Adverse Event Reporting System (FAERS) database

Acetylsalicylic acid (Aspirin), one of the oldest medicines, is widely used in various clinical fields. However, numerous adverse events (AEs) have been reported. In this study, we aimed to investigate adverse drug reactions (ADRs) of aspirin using real-worlddata from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. We assessed the disproportionality of aspirin-related AEs by calculating measures such as reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagationneural network (BCPNN), and Gamma-Poisson Shrinker (GPS). Out of 7,510,564 casereports in the FAERS database, 18644 reports of aspirin as the ‘primary suspected (PS)’ AEs were recorded. Disproportionality analyses identified 493 aspirin-related preferred terms (PTs) across 25 organ systems. Notably, unexpected significant AEs such as pallor (<i>p</i>=5.66E–33), dependence (<i>p</i>=6.45E–67), and compartment syndrome (<i>p</i>=1.95E–28) were observed, which were not mentioned in the drug’s instructions. Our findings align with clinical observations, highlighting potential new and unexpected ADR signals associated with aspirin. Further prospective clinical studies are necessary to confirm and elucidate the relationship between aspirin and these ADRs. This study offers a fresh and unique perspective for studying drug-AEs.

阿司匹林（Aspirin，化学名：乙酰水杨酸Acetylsalicylic acid）是最古老的药物之一，目前被广泛应用于各类临床领域。然而，已有大量不良事件（adverse events, AEs）相关报道。本研究旨在借助美国食品药品监督管理局（US Food and Drug Administration）不良事件报告系统（FAERS）的真实世界数据，探究阿司匹林的药品不良反应（adverse drug reactions, ADRs）。本研究通过计算报告比值比（reporting odds ratio, ROR）、比例报告比值比（proportional reporting ratio, PRR）、贝叶斯置信传播神经网络（Bayesian confidence propagation neural network, BCPNN）以及伽马-泊松收缩器（Gamma-Poisson Shrinker, GPS）等指标，评估阿司匹林相关不良事件的失衡性。在FAERS数据库的7510564份病例报告中，共计记录到18644份以阿司匹林为“首要可疑（primary suspected, PS）”的不良事件报告。失衡性分析共在25个器官系统中鉴定出493种与阿司匹林相关的首选术语（preferred terms, PTs）。值得注意的是，本研究观察到了药品说明书中未提及的、具有统计学意义的意外不良事件，如苍白（p=5.66×10^-33）、依赖性（p=6.45×10^-67）及骨筋膜室综合征（p=1.95×10^-28）。本研究结果与临床观测结果相符，凸显了与阿司匹林相关的潜在新型、意外药品不良反应信号。后续仍需开展前瞻性临床研究，以验证并阐明阿司匹林与这些不良反应之间的关联。本研究为药物-不良事件关联研究提供了全新的独特视角。