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

2020 ◽  
Vol 40 (11) ◽  
pp. 1099-1107
Author(s):  
Mohamed Mohamoud ◽  
Casie Horgan ◽  
Efe Eworuke ◽  
Elizabeth Dee ◽  
Justin Bohn ◽  
...  
Keyword(s):  
Adverse Event ◽  
Reporting System ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Small Vessel ◽  
Small Vessel Vasculitis ◽  
Event Reporting

scholarly journals Comparison of bleeding risks among non-vitamin K antagonist oral anticoagulants using the Korea adverse event reporting system database

2019 ◽  
Vol 10 ◽  
pp. 204209861987673
Author(s):  
Young-Jin Ko ◽  
Seonji Kim ◽  
Kyounghoon Park ◽  
Minsuk Kim ◽  
Bo Ram Yang ◽  
...  
Keyword(s):  
Adverse Event ◽  
Vitamin K ◽  
Major Bleeding ◽  
Reporting System ◽  
Oral Anticoagulants ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Vitamin K Antagonist ◽  
Event Reporting ◽  
System Database

Background: In order to ensure safer use of non-vitamin K antagonist oral anticoagulants (NOACs), continuously detecting unexpected adverse drug reactions (ADRs) after market approval is necessary. Methods: We performed disproportionality analysis to evaluate association between ADRs and NOACs including apixaban, dabigatran, and rivaroxaban using data from the Korea Institute of Drug Safety and Risk Management–Korea Adverse Event Reporting System database (KIDS-KD) between 2012 and 2016. There was no significant signal other than bleeding when considering quantity, signal strength, seriousness, and causality. In order to evaluate the NOAC reports about bleeding, we selected 62 WHO-ART diagnostic codes associated with bleeding. Among the 26 codes that referred to major bleeding, 18 codes referred to gastrointestinal bleeding and 8 were referred to intracranial bleeding. We evaluated the significance of the signals using reporting odds ratios (RORs) adjusted for age and sex. Results: Treatments with apixaban, dabigatran, and rivaroxaban were associated with 1989, 1668, and 2960 adverse events, respectively. Any type of bleeding with apixaban, dabigatran, rivaroxaban, and warfarin was reported in 174 (8.8%), 209 (12.5%), 523 (17.8%), and 620 (9.5%) events, respectively. For any bleeding, adjusted RORs of apixaban, dabigatran, and rivaroxaban were 0.99 [95% confidence interval (CI): 0.83–1.17], 1.47 (95% CI: 1.25–1.75), and 2.48 (95% CI: 2.16–2.84), respectively. With respect to major bleeding, the adjusted RORs of apixaban, dabigatran, and rivaroxaban were 1.08 (95% CI: 0.82–1.41), 1.46 (95% CI: 1.10–1.90), and 1.82 (95% CI: 1.43–2.32), respectively. Conclusion: Rivaroxaban might have stronger association with bleeding than apixaban and dabigatran.

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