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

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

doi:10.2174/0115748863276447231108092936

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

Curr Drug Saf. 2023 Nov 21. doi: 10.2174/0115748863276447231108092936. Online ahead of print.

Authors

Sourabh Raghuvanshi¹, Mohammad Akhlaquer Rahman², Mahesh Kumar Posa³, Anoop Kumar⁴

Affiliations

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.

PMID: 37990902
DOI: 10.2174/0115748863276447231108092936

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.

Keywords: Disproportionality analysis; FAERS; OpenVigil 2.1; Sensitivity analysis; Signal detection; US-FDA approved drugs.