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Complementary Use of U.S. FDA’s Adverse Event Reporting System and Sentinel System to Characterize Direct Oral Anticoagulants‐Associated Cutaneous Small Vessel Vasculitis

    Basic Details

    Cutaneous small vessel vasculitis (CSVV) has been reported after exposure to direct oral anticoagulants (DOACs), such as dabigatran, rivaroxaban, apixaban, and edoxaban. We used the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) to describe clinical characteristics associated with CSVV among DOAC‐exposed patients. Furthermore, we characterized this signal in the Sentinel System to relate the clinical data from the individual FAERS cases to population‐based electronic healthcare data.


    Mohamed Mohamoud, Casie Horgan, Efe Eworuke, Elizabeth Dee, Justin Bohn, Oren Shapira, Monica A. Munoz, Danijela Stojanovic, Veronica Sansing‐Foster, Adebola Ajao, Lois La Grenade

    Corresponding Author

    Mohamed Mohamoud; Division of Epidemiology, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA