Pradaxa Has No Antidote

Pradaxa has no antidote. It is often used as an alternative to the medicine warfarin. Although a physician may reverse the blood-thinning effects of warfarin by administering Vitamin K, Pradaxa has no similar safety mechanism. If a person who is using Pradaxa requires unexpected surgery, the physician treating the patient may have a far more difficult time stopping serious bleeding, because the patient’s blood is unable to clot.

The RE-LY Clinical Trial found 17.4% of Pradaxa users who needed non-elective surgery experienced serious bleeding.

The RE-LY Clinical Trial

The “Randomized Evaluation of Long-term Anti-Coagulation Therapy” (RE-LY) clinical trial compared the efficacy of Pradaxa and warfarin. Each medication was administered in a blinded manner to patients had atrial fibrillation. These patients were at increased risk for stroke associated with systemic embolisms (blood clots).

Findings of the RE-LY Clinical Trial and Bleeding:
  • 16.4% of people taking Pradaxa experience bleeding
  • 17.4% of people taking Pradaxa who needed emergency surgery experienced major bleeding
  • 3.3% of users experience serious bleeding
  • 1.5% experience life-threatening bleeding
  • 0.3% experience bleeding in the brain (cerebral hemorrhage)
Other side effects of Pradaxa

Gastrointestinal problems are also experienced by up to 35% of people taking Pradaxa. Problems may include indigestion, abdominal pain, ulcers of the digestive tract, black or tarry stools, gastroesophageal reflux disease, and more.
Other side effects may include:
  • severe allergic reaction requiring hospitalization
  • anaphylactic reaction
  • anaphylactic shock
  • myocardial infarction
  • elevations in liver transaminases
  • bilirubin and hepatic dysfunction
  • easy bruising
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