Sourabh Raghuvanshi, Mohammad Akhlaquer Rahman, Mahesh Kumar Posa, Anoop Kumar
{"title":"使用歧化分析识别与美国fda批准的药物相关的新信号(2013)。","authors":"Sourabh Raghuvanshi, Mohammad Akhlaquer Rahman, Mahesh Kumar Posa, Anoop Kumar","doi":"10.2174/0115748863276447231108092936","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Drugs are related with various adverse drug reactions (ADRs), however, many unexpected ADRs of drugs are reported through post-marketing surveillance.</p><p><strong>Aim: </strong>The current study's goal is to uncover potential signals connected with FDA-approved medications in the United States (2013).</p><p><strong>Methods: </strong>Open Vigil 2.1-MedDRA-v24 (data 20004Q1-2021Q3) was used as a tool to query the FAERS data. To find possible signals, disproportionality measures such as Proportional Reporting Ratio (PRR 2) with associated Chi-square value, Reporting Odds Ratio (ROR 2) with 95% confidence interval, and case count (3) were calculated.</p><p><strong>Results: </strong>A total of eight potential signals were identified with five drugs. Positive signals were found with pomalidomide, canagliflozin, dolutegravir sodium, macitentan and ibrutinib.</p><p><strong>Conclusion: </strong>However, further causality assessment is required to confirm the association of these drugs with identified potential signals.</p>","PeriodicalId":10777,"journal":{"name":"Current drug safety","volume":null,"pages":null},"PeriodicalIF":1.1000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Identification of Novel Signals Associated with US-FDA Approved Drugs (2013) Using Disproportionality Analysis.\",\"authors\":\"Sourabh Raghuvanshi, Mohammad Akhlaquer Rahman, Mahesh Kumar Posa, Anoop Kumar\",\"doi\":\"10.2174/0115748863276447231108092936\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Drugs are related with various adverse drug reactions (ADRs), however, many unexpected ADRs of drugs are reported through post-marketing surveillance.</p><p><strong>Aim: </strong>The current study's goal is to uncover potential signals connected with FDA-approved medications in the United States (2013).</p><p><strong>Methods: </strong>Open Vigil 2.1-MedDRA-v24 (data 20004Q1-2021Q3) was used as a tool to query the FAERS data. To find possible signals, disproportionality measures such as Proportional Reporting Ratio (PRR 2) with associated Chi-square value, Reporting Odds Ratio (ROR 2) with 95% confidence interval, and case count (3) were calculated.</p><p><strong>Results: </strong>A total of eight potential signals were identified with five drugs. Positive signals were found with pomalidomide, canagliflozin, dolutegravir sodium, macitentan and ibrutinib.</p><p><strong>Conclusion: </strong>However, further causality assessment is required to confirm the association of these drugs with identified potential signals.</p>\",\"PeriodicalId\":10777,\"journal\":{\"name\":\"Current drug safety\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.1000,\"publicationDate\":\"2024-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Current drug safety\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2174/0115748863276447231108092936\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Current drug safety","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2174/0115748863276447231108092936","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Identification of Novel Signals Associated with US-FDA Approved Drugs (2013) Using Disproportionality Analysis.
Background: Drugs are related with various adverse drug reactions (ADRs), however, many unexpected ADRs of drugs are reported through post-marketing surveillance.
Aim: The current study's goal is to uncover potential signals connected with FDA-approved medications in the United States (2013).
Methods: Open Vigil 2.1-MedDRA-v24 (data 20004Q1-2021Q3) was used as a tool to query the FAERS data. To find possible signals, disproportionality measures such as Proportional Reporting Ratio (PRR 2) with associated Chi-square value, Reporting Odds Ratio (ROR 2) with 95% confidence interval, and case count (3) were calculated.
Results: A total of eight potential signals were identified with five drugs. Positive signals were found with pomalidomide, canagliflozin, dolutegravir sodium, macitentan and ibrutinib.
Conclusion: However, further causality assessment is required to confirm the association of these drugs with identified potential signals.
期刊介绍：
Current Drug Safety publishes frontier articles on all the latest advances on drug safety. The journal aims to publish the highest quality research articles, reviews and case reports in the field. Topics covered include: adverse effects of individual drugs and drug classes, management of adverse effects, pharmacovigilance and pharmacoepidemiology of new and existing drugs, post-marketing surveillance. The journal is essential reading for all researchers and clinicians involved in drug safety.
京公网安备 11010802042870号
京ICP备2023020795号-1
分享
求助内容：
应助结果提醒方式：
扫码关注我们
