A real-world disproportionality analysis of colchicine: data mining of the public version of FDA Adverse Event Reporting System

Colchicine is widely used for gout and familial Mediterranean fever (FMF) and has cardiovascular benefits. However, it is linked to various adverse drug reactions (ADRs). This study aimed to analyze colchicine-related ADRs using FAERS data for safer clinical use. FAERS data from April 2005 to March 2024 were analyzed using ROR, PRR, BCPNN, and EBGM algorithms. ADRs were categorized by System Organ Classes (SOCs) and Preferred Terms (PTs). A total of 2,435 colchicine-related ADRs were identified. The most significant SOCs were Injury, poisoning, and procedural complications (<i>n</i> = 1,197, EBGM05 = 6.59) and Gastrointestinal disorders (<i>n</i> = 817, EBGM05 = 7.34). At the PT level, notable ADRs included Neuromyopathy (<i>n</i> = 27, EBGM05 = 153.12), Toxic cardiomyopathy (<i>n</i> = 8, EBGM05 = 138.58), and Spur cell anemia (<i>n</i> = 3, EBGM05 = 88.06). New signals at the PT level, including Necrotizing myositis (<i>n</i> = 6, EBGM05 = 31.22) and Septic arthritis staphylococcal (<i>n</i> = 3, EBGM05 = 28.94), were detected. Continuous monitoring is essential to detect established and emerging ADRs. These findings enhance understanding of colchicine’s safety profile, with further research needed to validate these signals.

秋水仙碱（Colchicine）广泛用于痛风及家族性地中海热（FMF）的治疗，同时具有心血管保护获益。然而，该药物与多种药品不良反应（ADRs）相关。本研究旨在利用食品药品监督管理局不良事件报告系统（FAERS）数据，分析秋水仙碱相关不良反应，以指导临床更安全地用药。本研究分析了2005年4月至2024年3月的FAERS数据，采用报告比值比（ROR）、比例报告比值比（PRR）、贝叶斯置信神经网络（BCPNN）及经验贝叶斯几何均值（EBGM）算法开展分析。按系统器官分类（SOCs）与首选术语（PTs）对不良反应进行分类归类。最终共识别出2435例秋水仙碱相关不良反应。其中最具统计学意义的系统器官分类为损伤、中毒与操作相关并发症（n=1197，EBGM05=6.59）以及胃肠道疾病（n=817，EBGM05=7.34）。在首选术语层面，值得关注的不良反应包括神经肌病（n=27，EBGM05=153.12）、中毒性心肌病（n=8，EBGM05=138.58）及棘形红细胞贫血症（n=3，EBGM05=88.06）。研究同时检测到新的不良反应信号，包括坏死性肌炎（n=6，EBGM05=31.22）与葡萄球菌性化脓性关节炎（n=3，EBGM05=28.94）。持续监测对于识别已存在及新发的药品不良反应至关重要。本研究结果加深了对秋水仙碱安全性特征的认识，未来仍需开展进一步研究以验证上述新发现的信号。