Scholarlink

<p>This study aims to assess the adverse event profile of vedolizumab (Entyvio<sup>®</sup>) using FDA Adverse Event Reporting System (FAERS) data to identify potential safety risks and support clinical use. FAERS data from Q1 2014 to Q1 2024 were analyzed. Adverse drug events (ADEs) related to vedolizumab were extracted and evaluated using four signal detection. Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM). Analysis included 50,852 reports identifying vedolizumab as the primary suspected drug. At the system organ class (SOC) level, it was significantly associated with gastrointestinal disorders, pregnancy-related conditions, infections, and procedural complications. Using all four algorithms, 103 adverse event (AE) signals were detected, with venous access complications, urgency of defecation, and fistulas being most common. Notable AEs absent from the drug label were also identified. This study underscores certain safety risks of vedolizumab, particularly gastrointestinal reactions and infections, providing valuable evidence for clinical decision-making and future research.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Pharmacovigilance study of adverse events of vedolizumab based on the FAERS database

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年10月28日

查看全文
  • Guanghui Yuan,
  • Jie Liu,
  • Yi Xu,
  • Zhaowei Shan

摘要

This study aims to assess the adverse event profile of vedolizumab (Entyvio®) using FDA Adverse Event Reporting System (FAERS) data to identify potential safety risks and support clinical use. FAERS data from Q1 2014 to Q1 2024 were analyzed. Adverse drug events (ADEs) related to vedolizumab were extracted and evaluated using four signal detection. Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM). Analysis included 50,852 reports identifying vedolizumab as the primary suspected drug. At the system organ class (SOC) level, it was significantly associated with gastrointestinal disorders, pregnancy-related conditions, infections, and procedural complications. Using all four algorithms, 103 adverse event (AE) signals were detected, with venous access complications, urgency of defecation, and fistulas being most common. Notable AEs absent from the drug label were also identified. This study underscores certain safety risks of vedolizumab, particularly gastrointestinal reactions and infections, providing valuable evidence for clinical decision-making and future research.