Skip to main content

Eliquis (Apixaban) & Gastrointestinal (GI) Bleed, Intracranial Hemorrhage, and Stroke

    Basic Details
    Last Updated
    Monday, March 18, 2024
    Original Posting Date
    Health Outcome(s)
    gastrointestinal (GI) bleed
    intracranial hemorrhage
    Drug and Outcome Analysis
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    This study was previously conducted in the Mini-Sentinel pilot program to assess the benefit-risk profile of using Eliquis (apixaban) compared to warfarin in patients with atrial fibrillation (AF). The original analysis suggested a signal of harm for apixaban use related to the health outcome of intracranial hemorrhage (ICH). However, the number of apixaban users in the original analysis was low as apixaban was approved in 2014. Therefore, an updated study with increased sample size was required. This study found that in AF patients of all ages initiating either apixaban or warfarin for stroke prevention, apixaban was associated with a decreased risk of gastrointestinal (GI) bleeding, ICH, and ischemic stroke compared with warfarin. No regulatory action was required as findings suggested a favorable benefit-risk profile for apixaban compared to warfarin for stroke prevention in patients with AF.