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

Sourabh Raghuvanshi¹, Mohammad Akhlaquer Rahman², Mahesh Kumar Posa³

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

Current Drug Safety

|November 22, 2023

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:

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

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