Title:Identification of Novel Signals Associated with US-FDA Approved Drugs
(2013) Using Disproportionality Analysis
Volume: 19
Issue: 3
Author(s): Sourabh Raghuvanshi, Mohammad Akhlaquer Rahman, Mahesh Kumar Posa and Anoop Kumar*
Affiliation:
- Department of Pharmacology, Delhi Pharmaceutical Sciences and Research
University (DPSRU), New Delhi, 110017, India
Keywords:
US-FDA approved drugs, openvigil 2.1, FAERS, disproportionality analysis, signal detection, sensitivity analysis.
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.
