November 5, 2014 — JAMA Internal Medicine has published a massive study linking Pradaxa to significantly higher rates of bleeding, including a 60% increased risk of major bleeding compared to warfarin.
The researchers took a random 5% sample of Medicare beneficiaries with atrial fibrillation who started taking Pradaxa or warfarin in 2010 or 2011. Compared to warfarin, Pradaxa was associated with the following risks:
- 30% increased risk for any bleeding event.
- 58% increased risk for major bleeding.
- 85% increased risk for gastrointestinal bleeding.
The results of the study are a sharp contrast to the RE-LY clinical trial, a pivotal safety study the FDA used to approve Pradaxa in 2010 after a 6-month, expedited approval process. RE-LY found no difference in major bleeding between Pradaxa and warfarin.
In May 2014, an FDA analysis of Medicare data backed up findings from RE-LY. However, the researchers criticized this analysis for failing to adjust for patient risk-factors that influence bleeding. For example, patients on warfarin tended to have kidney disease, heart failure, diabetes, and more. Failing to adjust for these risk-factors could skew the results in favor of Pradaxa.
In May 2014, the manufacturer of Pradaxa agreed to settle about 4,000 lawsuits in for $650 million. Members of the litigation accuse Boehringer Ingelheim of downplaying risk information linking Pradaxa and major bleeding.
Since then, evidence has emerged that they failed to include 22 major bleeding events from the RE-LY trial. They also apparently knew that blood tests and routine patient monitoring could improve the safety of Pradaxa, but failed to share those findings with health officials.
Do I have a Pradaxa Lawsuit?
The Schmidt Firm, PLLC is currently accepting Pradaxa injury cases in all 50 states. If you or somebody you know was injured by severe bleeding, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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