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

Abstract

Drugs are related with various adverse drug reactions (ADRs), however, many unexpected ADRs of drugs are reported through post-marketing surveillance. The current study's goal is to uncover potential signals connected with FDA-approved medications in the United States (2013). 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. A total of eight potential signals were identified with five drugs. Positive signals were found with pomalidomide, canagliflozin, dolutegravir sodium, macitentan and ibrutinib. However, further causality assessment is required to confirm the association of these drugs with identified potential signals.