Safety of direct oral anticoagulants reversal agents in older patients: an analysis of individual case safety reports of adverse drug reaction from VigiBase^®.

ABSTRACT:

Background

Real-world data on adverse drug reactions (ADRs) associated with idarucizumab and andexanet alfa are limited.

Aim

This study aimed to assess the frequency, the characteristics and clinical and demographic factors associated with ADRs related to their use.

Methods

This is a retrospective analysis of ADR reports collected in Vigibase^® until May 31, 2023. Multivariable logistic regression estimated reporting odds ratios (RORs) for serious ADRs, death, and thromboembolic events according to demographical and clinical covariates.

Results

A total of 1095 Individual Case Safety Reports (ICSRs) reporting idarucizumab (72%) or andexanet alfa (28%) as suspected/interacting agents were collected. Most of the subjects were males (44.5%), with a median

SUBMITTER: Crescioli G 

PROVIDER: S-EPMC11976745 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature