Adverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event Reporting Systems.

ABSTRACT:

Purpose

The purpose of this study was to investigate the adverse events (AEs) related to the use of off-label drugs.

Materials and methods

A cross-sectional study was carried out using available data pertaining to off-label drug were sourced from U.S. FDA spontaneous adverse drug reaction reporting database (FAERS) and Korea Adverse Event Reporting System database (KIDS-KD) for the years 2014 to 2018. The number and frequencies of AE cases were calculated. Disproportionality was analyzed using the proportional reporting ratio (PRR), the reporting odds ratio (ROR), the information component (IC), and the empirical Bayes geometric mean (EBGM) methods.

Results

The reported AEs associated with off-label drug use were more common among older patients compared with younger

SUBMITTER: Han N 

PROVIDER: S-EPMC8387311 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature