| アブストラクト | BACKGROUND: 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. RESEARCH DESIGN AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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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| ジャーナル名 | Expert opinion on drug safety |
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| Pubmed追加日 | 2023/11/1 |
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| 投稿者 | Li, Jie; Wang, Yilei; Yang, Xiang; Zhu, Haohao; Jiang, Zhitao |
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| 組織名 | 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.;Department of Pharmacy, Wuxi Central Rehabilitation Hospital, Affiliated Mental;Health Center of Jiangnan University, Wuxi, Jiangsu, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37909653/ |
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