不良事件报告系统
低血糖
医学
药物警戒
数据库
药物数据库
医学名词
格列美脲
不利影响
药物流行病学
二甲双胍
内科学
药理学
药方
药品
计算机科学
胰岛素
作者
Jie Liu,Yilei Wang,Yang Xiang,Hongyi Zhu,Zhitao Jiang
标识
DOI:10.1080/14740338.2023.2278700
摘要
Hypoglycemia is an adverse event (AE) that cannot be ignored in clinical practice. This study aimed to identify the most common and top drugs associated with the risk of hypoglycemia based on the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.We used OpenVigil 2.1 pharmacovigilance analytics platform to query FAERS database and data from 2004 to 2023 were retrieved. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify hypoglycemia cases, and DrugBank database was used to determine drug generic names.A total of 11,155,106 AEs reports were identified, of which 28,443 (0.25%) were related to hypoglycemia. Metformin (6926 cases) was associated with most cases of hypoglycemia. According to the disproportionality analysis, the top five drugs with the highest ROR and PRR were penamecillin, nikethamide, sotagliflozin, norethandrolone, glimepiride/pioglitazone. Nineteen of the top 50 drugs did not have hypoglycemia indicated in the package insert.By analyzing the FAERS database, we listed drugs with a strong hypoglycemic signal for which the label does not provide a reminder. Notably, the potential hypoglycemia risks are of great importance and should be closely monitored in medical practice.
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