November 7, 2014 — Two new studies have linked Pradaxa to a higher risk of bleeding compared to warfarin, refuting data from the RE-LY clinical trial Boehringer Ingelheim used to get the blood-thinner fast-track approved in 2010.
Circulation published a study that offered some reassurance. Conclusions were based on over 134,000 Medicare patients with atrial fibrillation between October 2010 and December 2012.
The study linked Pradaxa with a lower risk of ischemic stroke, intracranial hemorrhage, and death compared to warfarin. No difference was seen in rates of major bleeding, heart attack, or hospital bleeding.
Confirming data from RE-LY, Pradaxa was linked to a 28% increased risk of gastrointestinal bleeding.
In another massive study of Medicare patients, JAMA Internal Medicine linked Pradaxa with an 85% increased risk of gastrointestinal bleeding compared to warfarin, a 58% increased risk for major bleeding, and a 30% increased risk of bleeding overall in any area of the body.
In an accompanying editorial to the JAMA study, editor-in-chief Dr. Rita Redberg warned that an FDA review of the RE-LY study earlier this year may have been inaccurate:
“The authors note the FDA [study] failed to adjust for differences in patient characteristics, which would bias the results. [The findings] give us cause for concern because it appears that the bleeding risk for dabigatran is higher than for warfarin and significantly greater than originally appeared at the time of the FDA approval.”
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