Pradaxa Study Finds 60% More Major Bleeding than Warfarin

November 5, 2014 — A large study has linked the blood-thinning drug Pradaxa with a significant increased risk of bleeding compared to warfarin.

The study, published in JAMA Internal Medicine, looked at medical claims in 2010 and 2011 from a random sample of 5% of Medicare patients. 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 findings are a stark contrast to data from the RE-LY clinical trial, which found no difference in major bleeding between Pradaxa and warfarin. The manufacturer of Pradaxa used data from RE-LY to justify an accelerated review process lasting just six months. The FDA approved Pradaxa in 2010.

The researchers warned that other studies were flawed because they did not adjust for patient factors that directly affect the risk of bleeding. Patients on warfarin had risk-factors (kidney disease, heart failure, diabetes, etc.) that increased their risk of bleeding, which would have skewed results.

Thousands of people have filed lawsuits accusing Boehringer Ingelheim of downplaying the bleeding risks of Pradaxa. In May, the drug-maker offered to settle 4,000 lawsuits for $650 million.

Unlike warfarin, which can be de-activated with a dose of Vitamin K, Pradaxa has no quick reversal agent. When a patient starts bleeding, doctors must remove Pradaxa from the bloodstream so blood clots can form. Unfortunately, the only way to do this is with several hours of dialysis. In an emergency, it may be too late.

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