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FDA to Review Pradaxa Internal Bleeding & Hemorrhaging Reports

FDA to Review Pradaxa Internal Bleeding & Hemorrhaging Reports

The FDA announced that it will be reviewing reports of internal bleeding and internal hemorrhaging linked to Pradaxa, a stroke-prevention drug. The European Medicines Agency reported 256 cases of fatal bleeding caused by Pradaxa, and cautioned doctors when prescribing the medication.

The FDA warned physicians not to prescribe Pradaxa to patients with poor kidney function. The kidneys are responsible for removing toxins from the bloodstream. In patients with poor kidney function, Pradaxa may build up in the bloodstream to unsafe levels, and the blood cannot clot. If the patient begins bleeding, a physician may not be able to stop the bleeding.

The FDA review of Pradaxa will need to determine whether bleeding is more common in patients taking Pradaxa compared to warfarin. Pradaxa is the first drug that has been approved as an alternative to warfarin, a blood-thinning medication prescribed to prevent strokes associated with blood clots.

The review will be difficult because warfarin is known to cause bleeding, which is one of the reasons why an alternative medication has been highly desired. Bleeding caused by warfarin can be easily reversed with a dose of Vitamin K. Pradaxa, however, has no such safety mechanism. Warfarin has also been used for more than 50 years and is well-known to cause bleeding, which is why physicians rarely report these adverse events.

The most recent clinical trial linked Pradaxa to serious, life-threatening side effects — including internal bleeding, internal hemorrhage, cerebral hemorrhage, and death. The findings of the RE-LY Clinical Trial were:

  • 16.4% of people taking Pradaxa experience bleeding
  • 3.3% experience serious bleeding
  • 1.5% experience life-threatening bleeding
  • 0.3% experience life-threatening bleeding in the brain.
  • 17.4% of people taking Pradaxa who needed emergency surgery experienced major bleeding

Do I have a Pradaxa Lawsuit?

The Schmidt Firm, PLLC is currently accepting Pradaxa injury cases in all 50 states. If you or somebody you know was injured by severe bleeding, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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