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

IF 1.1 Q4 PHARMACOLOGY & PHARMACY

Current drug safety Pub Date : 2024-01-01 DOI:10.2174/0115748863276447231108092936

Sourabh Raghuvanshi, Mohammad Akhlaquer Rahman, Mahesh Kumar Posa, Anoop Kumar

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引用次数: 0

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).

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.

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使用歧化分析识别与美国fda批准的药物相关的新信号(2013)。

背景:药物与各种药物不良反应(adr)有关，然而，许多意想不到的药物不良反应是通过上市后监测报告的。目的:当前研究的目标是发现与美国fda批准的药物相关的潜在信号(2013年)。方法:使用Open Vigil 2.1-MedDRA-v24(数据20004Q1-2021Q3)作为查询FAERS数据的工具。为了找到可能的信号，计算了歧化指标，如具有相关卡方值的比例报告比(PRR 2)、具有95%置信区间的报告优势比(ROR 2)和病例数(3)。结果:5种药物共鉴定出8种潜在信号。pomalidomide, canagliflozin, dolutegravir钠，macitentan和ibrutinib出现阳性信号。结论:然而，需要进一步的因果关系评估来证实这些药物与已识别的潜在信号的关联。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Current drug safety PHARMACOLOGY & PHARMACY-

CiteScore

2.10

自引率

0.00%

发文量

112

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.