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Cutaneous Small Vessel Vasculitis and Acute Kidney Injury Following Direct-Acting Oral Anticoagulant Use

    Basic Details
    Date Posted
    Medical Product
    direct oral anticoagulant (DOAC)
    Health Outcome(s)
    acute kidney injury
    cutaneous small-vessel vasculitis

    In this report, we investigated counts of cutaneous small vessel vasculitis (CSVV) diagnoses in patients without prior autoimmune disease who had prior direct-acting oral anticoagulant (DOAC) exposure or diagnosis of atrial fibrillation. We additionally evaluated counts of acute kidney injury (AKI) diagnoses among patients with prior DOAC exposure in the Sentinel Distributed Database (SDD). We included in this report data from January 1, 2010 to June 30, 2018 from 17 Data Partners contributing to the SDD. This request was distributed on December 11, 2018.

    Additional Details
    FDA Center
    Time Period
    January 1, 2010 - June 30, 2018
    Analysis Type
    Population / Cohort
    Individuals 30 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)