Evaluation of Dabigatran Bleeding Adverse Reaction Reports in the FDA Adverse Event Reporting System during the First Year of Approval
Why the study?
Does dabigatran have a higher rate of reported fatal bleeding events compared to warfarin in real-world post-marketing surveillance?
Population
Adverse event reports in the United States from October 1, 2010, through December 31, 2011, listing…
Comparison
Dabigatran vs Warfarin
Design
Cohort
Authors
Discussion
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Member takes
Implication
Higher reported fatal bleeding proportion with dabigatran warrants interpretive caution; leaves open true risk versus warfarin due to surveillance bias.
Structured PICO
Does dabigatran have a higher rate of reported fatal bleeding events compared to warfarin in real-world post-marketing surveillance?
P
Population
Adverse event reports in the United States from October 1, 2010, through December 31, 2011, listing dabigatran or warfarin as the primary suspected agent.
I
Intervention
Dabigatran
C
Comparator
Warfarin
O
Outcome
Bleeding events and related fatal outcomessafety
Post-marketing surveillance data suggests that the proportion of fatal outcomes among reported bleeding events is higher for dabigatran than for warfarin, highlighting potential real-world safety concerns not fully captured in clinical trials.
Limitations
- Underreporting bias
- Significant bias inherent to FAERS reports
Cite This Study
McConeghy et al. (2014) studied this question.