Oral anticoagulants-induced intracranial hemorrhage: a real-world pharmacovigilance study over 2008-2024.

Abstract

This study aims to review and describe the national post-market cases of Oral anticoagulants (OACs)-induced intracranial hemorrhage (ICH) to enhance patient safety. All ICH cases of OACs as primary suspected medicines were extracted from the FAERS. The disproportionality analysis was utilized to signal detection. Subgroup analyses and logistic regression were conducted according to age, sex, weight, hypertension status, concomitant antiplatelet drugs and indications. Stratification analysis was performed according to ICH locations. In total 11,201 cases of OACs-induced ICH were identified from 2008Q1 to 2024Q1. The median time-to-onset (TTO) and median age for OACs-induced ICH was 181 days and 75 years, respectively. Most potent positive signal was subdural hemorrhage in rivaroxaban and vitamin K antagonists (VKAs), spinal cord hemorrhage in apixaban, hemorrhagic cerebellar infarction in edoxaban and extra-axial hemorrhage in dabigatran (IC025: 4.04, 5.00, 3.45, 6.09 and 3.51, respectively). After adjusting for confounding factors, lower ICH risks were observed in direct oral anticoagulants (DOACs), compared to VKAs. DOACs demonstrated a robust lower risk of ICH compared with VKAs. Different OACs exhibited distinct risk profiles at different ICH sites. The majority of DOACs-induced ICH occurred within 5 months and in elderly patients.