Safety of Vortioxetine in Patients With Depression: A Post-Marketing Surveillance Study of Intracranial Hemorrhage in a Japanese Health Insurance Claims Database.

ABSTRACT:

Aim

As part of a post-marketing commitment, this study evaluated the incidences of intracranial hemorrhage and serious (intracranial or gastrointestinal) hemorrhage requiring hospitalization in Japanese patients with depression prescribed vortioxetine or selective serotonin reuptake inhibitors (SSRIs).

Methods

This real-world, retrospective cohort study used data from the JMDC claims database. Patients with depression who received an initial prescription for vortioxetine or SSRIs (index date) between November 2019 and November 2022, with an observation period of 6 months before (look-back period) and up to 360 days after (follow-up period) the index date were included. The primary analysis estimated the incidence of intracranial hemorrhage, while the secondary analysis estim

SUBMITTER: Inoue T 

PROVIDER: S-EPMC12741241 | biostudies-literature | 2026 Mar

REPOSITORIES: biostudies-literature