Safety profile of the direct oral anticoagulants: an analysis of the WHO database of adverse drug reactions.

ABSTRACT:

Aim

Direct oral anticoagulants (DOACs) have shown noninferiority to warfarin for stroke prevention in nonvalvular atrial fibrillation (AF) and a more promising safety profile. Unanswered safety aspects remain to be addressed and available evidence on the risk associated with these drugs are conflicting. In order to contribute to the debate on their safety profile, we conducted a comparative analysis of the reports of suspected adverse drug reactions (ADRs) associated with DOACs in VigiBase.

Methods

Study based on reports of suspected ADRs held in VigiBase as at December 2014, in which a DOAC or warfarin were administered in patients with nonvalvular AF and listed as suspected/interacting drugs. Medical Dictionary for Regulatory Activities was used to classify ADRs. Reporting

SUBMITTER: Monaco L 

PROVIDER: S-EPMC5465343 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature