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Current Drug Safety

Author(s): Sourabh Raghuvanshi, Mohammad Akhlaquer Rahman, Mahesh Kumar Posa and Anoop Kumar*

DOI: 10.2174/0115748863276447231108092936

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

Page: [395 - 401] Pages: 7

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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.

Keywords: US-FDA approved drugs, openvigil 2.1, FAERS, disproportionality analysis, signal detection, sensitivity analysis.

Graphical Abstract

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