Bleeding Risks of Pradaxa, Other New Anticoagulants May Outweigh Benefits, New Study Suggests


Bleeding Risks of Pradaxa, Other New Anticoagulants May Outweigh Benefits, New Study SuggestsOverview: For patients who suffered from acute coronary syndrome (ACS), the use of new-generation anticoagulants such as Pradaxa, Xarelto and Eliquis may cause more harm than good, according to a study published in the Archives of Internal Medicine.



  • Study shows that the use of new oral anticoagulants like Pradaxa, Xarelto and Eliquis pose a major bleeding risk that may not be offset by the drugs’ benefits
  • Patients taking Pradaxa, Xarelto or Eliquis had a three-fold increases risk of bleeding
  • Pradaxa has already raised safety concerns due to reports of uncontrollable bleeding

Product: Pradaxa (dabigatran)

Manufacturer: Boehringer Ingelheim Pharmaceuticals

Side Effects & Complications

  • Cerebral hemorrhaging
  • Gastrointestinal (GI) hemorrhaging
  • All types of bleeds including the intraspinal, intraocular, intraarticular (joints), retroperitoneal or pericardial areas

The Study

Researchers conducted a meta-analysis involving 31,286 participants from seven different studies between 2000 and 2011. All of the patients had experienced some form of acute coronary syndrome (ACS), which refers to a group of symptoms suggesting that there is a blockage in the coronary arteries. In this study, participants were hospitalized due to unstable angina pectoris, ST-segment elevation myocardial infarction (STEMI), or non-STEMI. Although a slight decrease in ischemic events was observed, it was mostly off-set by the drugs’ bleeding risks, researchers said. Overall, patients taking the direct thrombin inhibitor Pradaxa or factor Xa inhibitors Xarelto and Eliquis after ACS had a three-fold increased risk of major bleeding events compared to those taking a placebo.

The authors concluded that “The use of anti-Xa or direct thrombin inhibitors is associated with a dramatic increase in major bleeding events, which might offset all ischemic benefits in patients receiving antiplatelet therapy after an ACS.”

Pradaxa Safety Concerns

This is not the first time Pradaxa has raised safety concerns over its bleeding risks. The drug was one of the first to replace warfarin, an older anticoagulant that required frequent monitoring and dietary restrictions. Initially, Pradaxa was hailed as an innovative medication for patients with atrial fibrillation, but its lack of a reversal agent-meaning that there is no cure if a patients experiences hemorrhaging-has become a major drawback.

Pradaxa’s safety issues have led some to question the whether or the U.S. Food and Drug Administration’s (FDA’s) expedited approval process. According to a report published earlier this month in the Journal of the American Medical Association, medications like Pradaxa “…raise the question of whether it was good policy to approve three innovative new drugs with significant safety questions unanswered,” According the ISMP’s latest QuarterWatch, Pradaxa was named in more adverse event reports than any other drug last year.