Skip to main content

Eliquis (Apixaban), Pradaxa (Dabigatran), and Xarelto (Rivaroxaban) & Cutaneous Small-Vessel Vasculitis

    Basic Details
    Last Updated
    Monday, July 31, 2023
    Original Posting Date
    Health Outcome(s)
    cutaneous small-vessel vasculitis
    Drug and Outcome Analysis
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    Cases of cutaneous small-vessel vasculitis (CSVV) associated with direct oral anticoagulants (DOACs) were reported in DOAC premarket trials and to the FDA Adverse Events Reporting System (FAERS) post approval. FDA conducted a study in Sentinel to characterize CSVV cases among patients with atrial fibrillation treated with DOACs. Additional studies in Sentinel explored incidence rates for DOACs, warfarin, and allopurinol as positive control and compared adjusted CSVV risk in new users of DOACs and warfarin. No statistically significant differential CSVV risk was observed among new users of DOACs and warfarin. FDA did not take regulatory action at this time, based on available information.