Pradaxa – FDA Investigating Serious Bleeding Reports

Pradaxa LawsuitsPradaxa, (dabigatran etexilate) is an oral blood thinner that was approved by the U.S. Food & Drug Administration (FDA) in October 2010. Pradaxa is in the class of anticoagulant (or anti-clotting) blood thinners called “direct thrombin inhibitors.” Doctors use the drug to help prevent serious blood clots and strokes in patients with atrial fibrillation. Atrial fibrillation is a heart condition in which the upper chambers of the heart, the atria, fail to contract fully causing potential stagnant blood and clot formation.

Most patients with atrial fibrillation are candidates for long-term anticoagulation. Until Pradaxa was placed on the market, patients were treated with oral Coumadin (Warfarin), injectable low molecular weight heparin, or less effectively with anti-platelet medications like aspirin. Warfarin has been most physicians’ treatment of choice for stroke prevention. However, Warfarin has problems involved with its use in the U.S.

Warfarin takes several days for anticoagulation to take effect and during that time, the patient needs frequent testing, sometimes daily. It may take several weeks to get the dosing just right and even after adequate anticoagulation is reached, monthly blood testing is necessary. Many foods in the diet and other drugs interfere with Warfarin. Because the therapeutic window for Warfarin is very narrow, it is common for patients to be over or under anticoagulated.


Pradaxa is approved at a single fixed dose for most patients. Common dosage is 150 mg twice daily and is effective within hours of its first dose.

Pradaxa has fewer drug interactions than Warfarin. Pradaxa also claims to be safe at its standard dosing levels, and does not need monthly blood tests to confirm adequate anticoagulation, unlike Warfarin. Seemingly, Pradaxa is an ideal drug for patients with atrial fibrillation. However, studies have shown that patients on Pradaxa have a 33% higher risk of heart attack or severe symptoms of heart disease when compared with patients taking Warfarin. Consequently, the FDA is investigating an unusually high number of reports of serious bleeding related to Pradaxa’s use.

Pradaxa Side Effects

Numerous dangerous side effects can occur in patients who are taking Pradaxa, including:

  • Gastrointestinal bleeding
  • Internal bleeding
  • Cerebral hemorrhage
  • Kidney bleeding
  • Colon bleeding
  • Death

Clinical Trial Results

The RE-LY clinical trial found that up to 16.4% of patients taking Pradaxa may experience internal hemorrhaging. They have also found that 17.4% of its users who needed emergency surgery experienced major bleeding resulting from use of Pradaxa. There have been reports of 260 Pradaxa related deaths worldwide.

Symptoms of excessive bleeding include:

  • Lethargy
  • Unusual bruising or bleeding
  • Pink or brown urine
  • Red or black tarry stools
  • Coughing up blood
  • Vomit that resembles blood or looks like coffee grounds
  • Headaches
  • Bleeding from gums
  • Frequent nosebleeds
  • Weakness and swelling of the arms, hands, feet, ankles or lower legs
  • Joint pain or swelling
  • Dizziness
  • Death

Free Case Evaluation – Contact Us

To date there have been a number of severe injuries and deaths associated with Pradaxa. If you or a loved one have suffered from Pradaxa related internal bleeding, or are a victim of a Pradaxa related injury or death, you may be eligible for financial compensation.

Call (631) 543-3663 or fill out a contact form for a free case evaluation. With over three decades of experience, the Commack, NY law firm of Rudolph F. X. Migliore, P.C. puts their product liability expertise to work for you and collaborates with nationally recognized associated firms to reach major verdicts and settlements for clients harmed by Pradaxa and other prescription drugs and defective medical devices.