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

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

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.

Deliverables (1)
Sentinel Modular Program Report: Cutaneous Small Vessel Vasculitis and Acute Kidney Injury Following Direct-Acting Oral Anticoagulant Use
Additional Details
FDA Center
CDER
Time Period
January 1, 2010 - June 30, 2018
Population / Cohort
Individuals 30 years of age and older
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Study: Eliquis (Apixaban), Pradaxa (Dabigatran), and Xarelto (Rivaroxaban) & Cutaneous Small-Vessel Vasculitis
ICPE 2019: Complementary Use of US FDA's Adverse Event Reporting System and Sentinel Distributed Database to Characterize Direct Oral Anticoagulants Associated Cutaneous Small Vessel Vasculitis