最近与索马鲁肽相关的不良反应已导致美国食品药品监督管理局（FDA）发出“黑箱警告”，有必要对所有不良反应报告进行分析，以提高其临床使用的安全性。 统计分析和信号通过获取 FAERS 数据库中 2018 年第一季度至 2023 年第四季度与索马鲁肽相关的不良事件报告来进行挖掘。我们使用不成比例性和贝叶斯分析来检查临床和人口统计属性、每季度报告的趋势以及两者之间的对比不同的适应症（肥胖和2型糖尿病）。我们发现了与“胰腺癌”、“肠梗阻”、“胆囊炎”和“多囊卵巢”相关的10个意想不到的不良信号，并且两种不同的适应症都有相同的严重不良反应事件这项研究发现了许多严重不良反应的意外信号，表明对索马鲁肽进行持续上市后监测以了解其潜在风险的重要性。© 2024 作者。亚洲糖尿病研究协会 (AASD) 和 John Wiley 出版的《Journal of Diabetes Investigation》

The recent adverse reactions associated with semaglutide have led the Food and Drug Administration (FDA) to issue a "black box warning", and it is necessary to analyze all reports of adverse reactions to improve the safety of its clinical use.Statistical analyses and signal mining were performed by obtaining the adverse event reports related to semaglutide in the FAERS database from the first quarter of 2018 to the fourth quarter of 2023. We used disproportionality and Bayesian analysis to examine clinical and demographic attributes, trends reported quarterly, and contrasts between two distinct indications (obesity and type 2 diabetes).We found 10 unexpected adverse signals related to "pancreatic cancer", "intestinal obstruction", "cholecystitis", and "polycystic ovary" and both the two different indications had the same serious adverse reaction events occurring.This study identified many unexpected signals of serious adverse reactions, suggesting the importance of continuous post-marketing surveillance of semaglutide to understand its potential risks.© 2024 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.