Risk of Bleeding Associated With Antidepressants: Impact of Causality Assessment and Competition Bias on Signal Detection.

ABSTRACT: Introduction: Until now, methods of pharmacovigilance as disproportionality analysis were not capable of proving the otherwise well-established increased bleeding risk related to antidepressants (ADs). As bleeding events with ADs often occur in combination with antithrombotics, they might not be considered causative of, but merely "linked" with, the bleeding event. Therefore, we hypothesized that the causality assessment of bleeding events in association with ADs and the competitive impact of antithrombotics are factors contributing to the non-findings of previous pharmacovigilance studies. Methods: We performed a case/non-case study based on data from VigiBase^TM and calculated reporting odds ratios (RORs) for 25 ADs. We used individual case safety reports (ICSRs)

SUBMITTER: Zeiss R 

PROVIDER: S-EPMC8566746 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature