New Study Casts Doubt On Whether The Minor Benefits of Pradaxa In Preventing Stroke Are Worth The Greater Bleeding Risk Compared To Coumadin / Warfarin


This page is a subpage to our main Pradaxa Lawsuits page.


Back when the Food & Drug Administration approved Pradaxa, the FDA reviewers said they recommended approval of Pradaxa as an alternative to warfarin / Coumadin because Pradaxa was modestly more effective in preventing stroke and systemic embolism — 1.11% of patients had an incident per year for Pradaxa versus 1.69% of patients for Warfarin — while being roughly the same in terms of bleeding risks.  That’s because the main study the FDA used in coming to that conclusion, the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) study, found that warfarin had a major bleeding rate of 3.36% per year while Pradaxa had a major bleeding rate of only 3.11% per year.  (A “major bleed” typically refers to a life-threatening bleed, most commonly, intracranial bleeding in the brain or gastrointestinal bleeding.)

A new meta-analysis in the Archives of Internal Medicine, “Current Trial-Associated Outcomes With Warfarin in Prevention of Stroke in Patients With Nonvalvular Atrial Fibrillation,” reviewed eight randomized controlled trials with at least 400 patients each and found that the risk of warfarin used by the RE-LY study may have been overstated. Those researchers found that the actual risk of a major bleed from warfarin is between 1.4% and 3.4% every year.

If that’s the case, then Pradaxa might still be slightly more effective than warfarin in preventing stroke or systemic embolism, but Pradaxa is potentially more than twice as likely to cause major bleeding than Coumadin, including life-threatening bleeding involving the brain or the internal organs.

Several lawsuits have been filed against the maker of Pradaxa, Boehringer Ingelheim Pharmaceuticals, alleging that:

  • Pradaxa wasn’t adequately tested,
  • Pradaxa’s warning labels and informational materials understate the risk of bleeding,
  • Pradaxa’s labels and other materials should warn patients and their doctors that the drug has a higher risk of serious bleeding effects than Coumadin; and,
  • Pradaxa’s labels and prescribing directions don’t warn patients or doctors that there’s no reversal agent for Pradaxa if a patient has an accident, a fall, or some other bleeding problems, unlike out Vitamin K can be used with Coumadin to quickly reverse its effects.

Right now, for example, the official website says that Pradaxa offers “lower total bleeds” than warfarin.



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