PMID- 31009121
OWN - NLM
STAT- MEDLINE
DCOM- 20191127
LR  - 20191127
IS  - 1600-0609 (Electronic)
IS  - 0902-4441 (Print)
IS  - 0902-4441 (Linking)
VI  - 103
IP  - 1
DP  - 2019 Jul
TI  - A comparative analysis of the safety profile of direct oral anticoagulants using 
      the FDA adverse event reporting system.
PG  - 43-46
LID - 10.1111/ejh.13240 [doi]
AB  - 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.
CI  - (c) 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
FAU - DeLoughery, Emma P
AU  - DeLoughery EP
AD  - Mayo Clinic School of Medicine, Mayo Clinic, Rochester, Minnesota.
FAU - Shatzel, Joseph J
AU  - Shatzel JJ
AUID- ORCID: 0000-0001-9396-5976
AD  - Division of Hematology, Oregon Health & Science University, Portland, Oregon.
LA  - eng
GR  - R01 HL101972/HL/NHLBI NIH HHS/United States
PT  - Journal Article
DEP - 20190506
PL  - England
TA  - Eur J Haematol
JT  - European journal of haematology
JID - 8703985
RN  - 0 (Anticoagulants)
RN  - 9NDF7JZ4M3 (Rivaroxaban)
SB  - IM
MH  - Administration, Oral
MH  - Ambulatory Care
MH  - Anticoagulants/administration & dosage/*adverse effects/classification
MH  - Databases, Factual
MH  - Drug Prescriptions
MH  - Humans
MH  - *Mandatory Reporting
MH  - Rivaroxaban/administration & dosage/adverse effects
MH  - United States
MH  - *United States Food and Drug Administration
MH  - Venous Thromboembolism/complications/drug therapy/epidemiology
PMC - PMC6786266
MID - NIHMS1053364
OTO - NOTNLM
OT  - anticoagulants
OT  - coagulation disorder
OT  - hemorrhage
OT  - thromboembolism
OT  - thrombosis
OT  - warfarin
COIS- Conflict of interest statement: The authors have no conflicts of interest
EDAT- 2019/04/23 06:00
MHDA- 2019/11/28 06:00
PMCR- 2019/10/10
CRDT- 2019/04/23 06:00
PHST- 2019/02/18 00:00 [received]
PHST- 2019/03/28 00:00 [revised]
PHST- 2019/04/01 00:00 [accepted]
PHST- 2019/04/23 06:00 [pubmed]
PHST- 2019/11/28 06:00 [medline]
PHST- 2019/04/23 06:00 [entrez]
PHST- 2019/10/10 00:00 [pmc-release]
AID - 10.1111/ejh.13240 [doi]
PST - ppublish
SO  - Eur J Haematol. 2019 Jul;103(1):43-46. doi: 10.1111/ejh.13240. Epub 2019 May 6.