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

Basic Details
Status
Complete
Last Updated
Monday, June 23, 2025
Original Posting Date
Health Outcome(s)
cutaneous small-vessel vasculitis
Purpose
Drug and Outcome Analysis
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Study Summary

Cases of cutaneous small-vessel vasculitis (CSVV) associated with direct oral anticoagulants (DOAC) (also known as non-vitamin K oral anticoagulants (NOAC)) 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 (dabigatran, rivaroxaban, apixaban) and warfarin. FDA did not take regulatory action at this time, based on available information. 

Given the low utilization of edoxaban, the Active Risk Identification and Analysis (ARIA) System was found to be insufficient for studying CSVV after edoxaban exposure. 
 

Analytic Code Link(s) (1)
Cutaneous Small-Vessel Vasculitis following Dabigatran, Rivaroxaban, and Apixaban Use in Patients with Atrial Fibrillation: A Propensity Score Matched Analysis
Result(s) (5)
Cutaneous Small-Vessel Vasculitis following Dabigatran, Rivaroxaban, and Apixaban Use in Patients with Atrial Fibrillation: A Propensity Score Matched Analysis Cutaneous Small-Vessel Vasculitis following Direct Oral Anticoagulants (DOACs), Warfarin, or Allopurinol Use in Patients with Atrial Fibrillation: A Descriptive Analysis Direct Oral Anticoagulants (DOACs), Warfarin, Allopurinol, or Propylthiouracil Use in Patients with Cutaneous Small-Vessel Vasculitis: A Descriptive Analysis Cutaneous Small Vessel Vasculitis and Acute Kidney Injury Following Direct-Acting Oral Anticoagulant Use Incident Utilization of Allopurinol, Hydralazine, and Propylthiouracil: A Descriptive Analysis
Related Publication(s) and/or Presentation(s) (5)
Presentation: Complementary Use of US FDA's Adverse Event Reporting System and Sentinel Distributed Database to Characterize Direct Oral Anticoagulants Associated Cutaneous Small Vessel Vasculitis Publication: Complementary Use of U.S. FDA’s Adverse Event Reporting System and Sentinel System to Characterize Direct Oral Anticoagulants‐Associated Cutaneous Small Vessel Vasculitis Presentation: Incidence of Cutaneous Small Vessel Vasculitis associated with Oral Anticoagulant Use Presentation: No Differential Risk of Cutaneous Small Vessel Vasculitis with Oral Anticoagulant Use Among Patients with Atrial Fibrillation Publication: A Cohort Study to Assess Risk of Cutaneous Small Vessel Vasculitis Among Users of Different Oral Anticoagulants