Pradaxa Internal Bleeding Lawsuit - Consumer Drug Report
Pradaxa linked to adverse side effects

Pradaxa is a blood thinning medication prescribed to prevent blood clots and strokes caused by atrial fibrillation, a condition in which a part of the heart does not beat the way it should. This medication is included in a class of drugs referred to as direct thrombin inhibitors that work by preventing an enzyme which causes the blood to clot.

On March 18, 2008, the European Medicine’s Agency approved Pradaxa marketing activities to prevent blood clots in patients who have had knee or hip surgery and for the treatment of non-valvular atrial fibrillation.

The Food and Drug Administration approved Pradaxa in October of 2010. Soon after its release, numerous complaints regarding adverse side effects were filed and sent to the FDA. A safety communication was issued in December of 2011. In this safety communication, the FDA warned the public about the side effects of using Pradaxa.

Common potential side effects caused by Pradaxa include internal bleeding, heart attack, gastrointestinal bleeding, brain hemorrhaging, kidney bleeding, and even death. The most serious of these side effects is internal bleeding. The excretion of Pradaxa through the kidneys hinders the kidneys ability to function, leading to an access of the drug traveling through the body thus causing internal bleeding to occur.

Side effects of internal bleeding may include:

  • Unexpected bleeding or unusually long lasting bleeding
  • Severe or uncontrollable bleeding
  • Pink or brown urine
  • Red or black stools
  • Bruises with unknown cause
  • Blood clots and coughing up blood
  • Blood in vomit or vomit with “coffee grounds” consistency
  • Unexpected pain, swelling, joint pain, headaches, dizziness, weakness

Researchers from Cleveland Clinic conducted a study and it was found that patients on Pradaxa are at a 33% higher risk for suffering a heart attack or sever symptoms of heart disease than patients taking warfarin, a competing blood thinning medication.

Currently, no recall has been issued; however, the FDA is in the process of investigating serious internal bleeding reports associated with Pradaxa use.


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