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

---