Drug-induced skin ulcer: real-world pharmacovigilance analysis based on the FDA adverse event reporting system

Skin ulcer (SU) may increase the risk of systemic infections and have evolved into an important public health problem. However, there is a lack of research specifically on drug-induced SU. We extracted data on adverse drug events (ADEs) associated with SU from the FDA Adverse Event Reporting System (FAERS) database. Disproportionality analysis was performed to calculate the risk signals for drugs that may induce SU. Logistic regression analysis was carried out to investigate the factors influencing the occurrence of SU. 21372 cases of SU were reported in FAERS database between 2005 and 2024. Based on the frequency of ADE reports, we compiled a list of the top 50 drugs associated with SU. Only 15 drugs had explicit mentions of SU in their instructions, while 32 drugs were recognized as positive signals for SU by reporting odds ratio model. Logistic regression revealed the duration of medication was the risk factor for tocilizumab, alendronate sodium, and erlotinib usage. Females were also identified as risk factor for erlotinib. Our study identified 32 drugs potentially inducing SU, which provides valuable insights for targeted prevention and treatment strategies aimed at mitigating the risk of drug-induced SU.

皮肤溃疡（Skin ulcer, SU）可升高全身性感染风险，现已演变为一项重要的公共卫生问题。然而，当前针对药物诱导性皮肤溃疡的专项研究仍较为匮乏。本研究从美国食品药品监督管理局药品不良事件报告系统（FDA Adverse Event Reporting System, FAERS）中提取了与皮肤溃疡相关的药品不良事件（Adverse Drug Events, ADEs）数据，采用比例失衡分析计算潜在诱导皮肤溃疡的药物风险信号，并通过Logistic回归分析探究影响皮肤溃疡发生的相关因素。2005年至2024年间，FAERS数据库中共报告21372例皮肤溃疡病例。基于药品不良事件报告频率，本研究整理出与皮肤溃疡关联度排名前50的药物列表。其中仅15种药物的药品说明书中明确提及皮肤溃疡，另有32种药物经报告比值比模型判定为皮肤溃疡阳性信号药物。Logistic回归分析结果显示，用药时长是使用托珠单抗、阿仑膦酸钠及厄洛替尼的风险影响因素；女性同样是厄洛替尼使用者发生皮肤溃疡的风险因素。本研究共筛选出32种潜在诱导皮肤溃疡的药物，可为制定针对性预防与治疗策略以降低药物诱导性皮肤溃疡风险提供重要参考依据。