Department of Pharmacy, Zhangjiagang TCM Hospital, Affiliated to Nanjing University of Chinese Medicine, Zhangjiagang, Jiangsu, China.
Department of Pharmacy, Taicang TCM Hospital, Affiliated to Nanjing University of Chinese Medicine, Taicang, Jiangsu, China.
Expert Opin Drug Saf. 2024 Aug;23(8):1061-1067. doi: 10.1080/14740338.2023.2278700. Epub 2023 Nov 9.
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.
低血糖是临床实践中不容忽视的不良事件（AE）。本研究旨在根据美国食品和药物管理局（FDA）不良事件报告系统（FAERS）数据库，确定与低血糖风险相关的最常见和排名最高的药物。
我们使用 OpenVigil 2.1 药物警戒分析平台查询 FAERS 数据库，检索了 2004 年至 2023 年的数据。使用监管活动医学词典（MedDRA）识别低血糖病例，使用 DrugBank 数据库确定药物的通用名。
共确定 11,155,106 例 AE 报告，其中 28,443（0.25%）与低血糖有关。二甲双胍（6926 例）与大多数低血糖病例相关。根据比例失衡分析，ROR 和 PRR 最高的前五种药物分别为 penamecillin、nikethamide、 sotagliflozin、norethandrolone、glimepiride/pioglitazone。在药品说明书中未提及前 50 种药物中的 19 种有低血糖的情况。
通过分析 FAERS 数据库，我们列出了具有强烈低血糖信号的药物，这些药物的标签并未提供提醒。值得注意的是，这些药物具有很大的潜在低血糖风险，在医疗实践中应密切监测。
