Identification of Novel Signals Associated with US-FDA Approved Drugs (2013) Using Disproportionality Analysis

Author:

Raghuvanshi Sourabh1,Rahman Mohammad Akhlaquer2,Posa Mahesh Kumar3,Kumar Anoop4

Affiliation:

1. Department of Clinical Research, Delhi Pharmaceutical Science and Research University (DPSRU), New Delhi 110017, India

2. Department of Pharmaceutics and Industrial Pharmacy, college of Pharmacy, Taif University, Taif-- 21944, Kingdom of Saudi Arabia

3. School of Pharmacy and Technology Management, SVKM’S NMIMS, Polepally SEZ, Jadcherla, Hyderabad, 509301, India

4. Department of Pharmacology, Delhi Pharmaceutical Science and Research University (DPSRU), New Delhi 110017, India

Abstract

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). Methodology: 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.

Publisher

Bentham Science Publishers Ltd.

Subject

Pharmacology (medical),Pharmacology,Toxicology

Cited by 1 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3