Pradaxa Study Shows Substantial Increase in Bleeding Risk

The trouble concerning Pradaxa® first began in December 2011 when its manufacturer acknowledged that more than 200 patients had died while taking the drug and the FDA issued a safety warning advising physicians and the public. Since that time, patients across the country and their families have filed actions in state and federal courts concerning the drug. As time continues to pass, more information continues to surface regarding the dangers of this drug.

In March of 2012, the American College of Cardiology released a study comparing the bleeding risks of Pradaxa with those of warfarin, the only other anticoagulant on the market in the United States. That study involved 290 patients of the average age of 60. Half received Pradaxa and the other half warfarin for 30 days prior to undergoing a surgical procedure to treat atrial fibrillation. Of the 145 patients in the Pradaxa group,

  • Nine suffered major bleeding complications as opposed to only one in the warfarin group
  • Twelve experienced minor bleeding complications as opposed to eight in the warfarin group
  • Three experienced embolic complications, including cerebrovascular accidents and transient ischemic attacks, as opposed to zero in the warfarin group

In total, 23 of the Pradaxa patients — or 16 percent of the test group — experienced either bleeding or embolic complications. This stands in stark contrast to the warfarin group, of which only nine — or six percent — experienced similar complications.

As evidence continues to mount regarding the increased risks of Pradaxa in comparison to its competitor warfarin, the FDA continues its investigation. As there continues to be no effective reversal agent for Pradaxa, the number of deaths and serious bleeding complications associated with the drug will likely continue to rise.