Yikuan Du, Jinfeng Zhu, Zhuoming Guo, Zhenjie Wang, Yuni Wang, Mianda Hu, Lingzhi Zhang, Yurong Yang, Jinjin Wang, Yixing Huang, Peiying Huang, Mianhai Chen, Bo Chen, Chun Yang
{"title":"二甲双胍不良事件概况:基于 2004 年至 2022 年 FDA 不良事件报告系统 (FAERS) 的药物警戒研究。","authors":"Yikuan Du, Jinfeng Zhu, Zhuoming Guo, Zhenjie Wang, Yuni Wang, Mianda Hu, Lingzhi Zhang, Yurong Yang, Jinjin Wang, Yixing Huang, Peiying Huang, Mianhai Chen, Bo Chen, Chun Yang","doi":"10.1080/17512433.2024.2306223","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Metformin has the potential for treating numerous diseases, but there are still many unrecognized and unreported adverse events (AEs).</p><p><strong>Methods: </strong>We selected data from the United States FDA Adverse Event Reporting System (FAERS) database from the first quarter (Q1) of 2004 to the fourth quarter (Q4) of 2022 for disproportionality analysis to assess the association between metformin and related adverse events.</p><p><strong>Results: </strong>In this study 10,500,295 case reports were collected from the FAERS database, of which 56,674 adverse events related to metformin were reported. A total of 643 preferred terms (PTs) and 27 system organ classes (SOCs) that were significant disproportionality conforming to the four algorithms simultaneously were included. The SOCs included metabolic and nutritional disorders (<i>p</i> = 0.00E + 00), gastrointestinal disorders (<i>p</i> = 0.00E + 00) and others. PT levels were screened for adverse drug reaction (ADR) signals such as acute pancreatitis (<i>p</i> = 0.00E + 00), melas syndrome, pemphigoid (<i>p</i> = 0.00E + 00), skin eruption (<i>p</i> = 0.00E + 00) and drug exposure during pregnancy (<i>p</i> = 0.00E + 00).</p><p><strong>Conclusion: </strong>Most of our results were consistent with the specification, but some new signals of adverse reactions such as acute pancreatitis were not included. Therefore, further studies are needed to validate unlabeled adverse reactions and provide important support for clinical monitoring and risk identification of metformin.</p>","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"189-201"},"PeriodicalIF":3.6000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Metformin adverse event profile: a pharmacovigilance study based on the FDA Adverse Event Reporting System (FAERS) from 2004 to 2022.\",\"authors\":\"Yikuan Du, Jinfeng Zhu, Zhuoming Guo, Zhenjie Wang, Yuni Wang, Mianda Hu, Lingzhi Zhang, Yurong Yang, Jinjin Wang, Yixing Huang, Peiying Huang, Mianhai Chen, Bo Chen, Chun Yang\",\"doi\":\"10.1080/17512433.2024.2306223\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Metformin has the potential for treating numerous diseases, but there are still many unrecognized and unreported adverse events (AEs).</p><p><strong>Methods: </strong>We selected data from the United States FDA Adverse Event Reporting System (FAERS) database from the first quarter (Q1) of 2004 to the fourth quarter (Q4) of 2022 for disproportionality analysis to assess the association between metformin and related adverse events.</p><p><strong>Results: </strong>In this study 10,500,295 case reports were collected from the FAERS database, of which 56,674 adverse events related to metformin were reported. A total of 643 preferred terms (PTs) and 27 system organ classes (SOCs) that were significant disproportionality conforming to the four algorithms simultaneously were included. The SOCs included metabolic and nutritional disorders (<i>p</i> = 0.00E + 00), gastrointestinal disorders (<i>p</i> = 0.00E + 00) and others. PT levels were screened for adverse drug reaction (ADR) signals such as acute pancreatitis (<i>p</i> = 0.00E + 00), melas syndrome, pemphigoid (<i>p</i> = 0.00E + 00), skin eruption (<i>p</i> = 0.00E + 00) and drug exposure during pregnancy (<i>p</i> = 0.00E + 00).</p><p><strong>Conclusion: </strong>Most of our results were consistent with the specification, but some new signals of adverse reactions such as acute pancreatitis were not included. Therefore, further studies are needed to validate unlabeled adverse reactions and provide important support for clinical monitoring and risk identification of metformin.</p>\",\"PeriodicalId\":12207,\"journal\":{\"name\":\"Expert Review of Clinical Pharmacology\",\"volume\":\" \",\"pages\":\"189-201\"},\"PeriodicalIF\":3.6000,\"publicationDate\":\"2024-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Expert Review of Clinical Pharmacology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/17512433.2024.2306223\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/29 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert Review of Clinical Pharmacology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/17512433.2024.2306223","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/29 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Metformin adverse event profile: a pharmacovigilance study based on the FDA Adverse Event Reporting System (FAERS) from 2004 to 2022.
Background: Metformin has the potential for treating numerous diseases, but there are still many unrecognized and unreported adverse events (AEs).
Methods: We selected data from the United States FDA Adverse Event Reporting System (FAERS) database from the first quarter (Q1) of 2004 to the fourth quarter (Q4) of 2022 for disproportionality analysis to assess the association between metformin and related adverse events.
Results: In this study 10,500,295 case reports were collected from the FAERS database, of which 56,674 adverse events related to metformin were reported. A total of 643 preferred terms (PTs) and 27 system organ classes (SOCs) that were significant disproportionality conforming to the four algorithms simultaneously were included. The SOCs included metabolic and nutritional disorders (p = 0.00E + 00), gastrointestinal disorders (p = 0.00E + 00) and others. PT levels were screened for adverse drug reaction (ADR) signals such as acute pancreatitis (p = 0.00E + 00), melas syndrome, pemphigoid (p = 0.00E + 00), skin eruption (p = 0.00E + 00) and drug exposure during pregnancy (p = 0.00E + 00).
Conclusion: Most of our results were consistent with the specification, but some new signals of adverse reactions such as acute pancreatitis were not included. Therefore, further studies are needed to validate unlabeled adverse reactions and provide important support for clinical monitoring and risk identification of metformin.
期刊介绍:
Advances in drug development technologies are yielding innovative new therapies, from potentially lifesaving medicines to lifestyle products. In recent years, however, the cost of developing new drugs has soared, and concerns over drug resistance and pharmacoeconomics have come to the fore. Adverse reactions experienced at the clinical trial level serve as a constant reminder of the importance of rigorous safety and toxicity testing. Furthermore the advent of pharmacogenomics and ‘individualized’ approaches to therapy will demand a fresh approach to drug evaluation and healthcare delivery.
Clinical Pharmacology provides an essential role in integrating the expertise of all of the specialists and players who are active in meeting such challenges in modern biomedical practice.