A comparative analysis of the safety profile of direct oral anticoagulants using the FDA adverse event reporting system

Introduction Direct oral anticoagulants (DOACs) are being increasingly used. However, unlike warfarin, less is known regarding their long‐term side effects. To better evaluate the rates of DOAC‐related adverse events (AEs) on a population level, we examined AEs reported to the FDA for three commonly...

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Bibliographic Details
Published in:European journal of haematology 2019-07, Vol.103 (1), p.43-46
Main Authors: DeLoughery, Emma P., Shatzel, Joseph J.
Format: Article
Language:English
Subjects:
Administration, Oral
Ambulatory Care
Anticoagulants
Anticoagulants - administration & dosage
Anticoagulants - adverse effects
Anticoagulants - classification
coagulation disorder
Comparative analysis
Databases, Factual
Drug Prescriptions
Drug screening
hemorrhage
Humans
Ischemia
Mandatory Reporting
Rivaroxaban - administration & dosage
Rivaroxaban - adverse effects
Thromboembolism
thrombosis
United States
United States Food and Drug Administration
Venous Thromboembolism - complications
Venous Thromboembolism - drug therapy
Venous Thromboembolism - epidemiology
Warfarin
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Summary:Introduction Direct oral anticoagulants (DOACs) are being increasingly used. However, unlike warfarin, less is known regarding their long‐term side effects. To better evaluate the rates of DOAC‐related adverse events (AEs) on a population level, we examined AEs reported to the FDA for three commonly used DOACs and warfarin. Methods We evaluated the FDA Adverse Event Reporting System (FAERS) database, which compiles reported drug‐related AEs from 1969 onwards. The safety profiles of the included drugs were assessed by comparing AEs per outpatient prescription and with proportional reporting ratios (PRR). Results Rivaroxaban had the highest proportion of reported AEs. Most notably the rate for breakthrough venous thromboembolism (VTE) was higher than other DOACs. Dabigatran had the highest reported rates of ischemic stroke. When the DOAC data were analyzed using PRR, reported rates of VTE were again higher with rivaroxaban while dabigatran again showed slightly higher than expected rates of ischemic stroke. Apixaban did not show higher than expected rates in any category. Conclusion Our analysis found rates of reported breakthrough VTE were significantly higher with rivaroxaban, while apixaban had no higher than expected rates of any studied AEs.
ISSN:0902-4441
1600-0609
1600-0609
DOI:10.1111/ejh.13240