Pradaxa linked to internal bleeding
EMA recommends updated Pradaxa labels
  • Tue, 05/29/2012 - 2:04pm

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) reported Friday that the number of reported fatal bleedings associated with Pradaxa use is far less than seen in clinical trials. After a thorough review, the agency says the benefits outweigh the risks and recommends Boehringer Ingleheim, the manufacturer of Pradaxa, update product information to aid both doctors and patients in reducing bleeding risks in patients with atrial fibrillation.

About Pradaxa

Pradaxa is an anticoagulant approved in the United States in October 2010 for treating atrial fibrillation not caused by a heart valve problem. Atrial fibrillation is a result of an irregular heart rhythm that can cause blood clots to form, increasing the risk of stroke and other deadly complications. Pradaxa is included in a class of drugs referred to as direct thrombin inhibitors that work by preventing the enzyme which causes blood cells to clot, or coagulate.

Side Effects

Though CHMP suggests that the benefits of Pradaxa outweigh the risks, you should still look out for these common side effects and report them to your doctor:

  • Heartburn
  • Nausea
  • Diarrhea
  • Belching
  • Black, tarry stools
  • Bloody stools
  • Constipation
  • Indigestion
  • Pain or throat burning
  • Stomach pain, burning, or discomfort
  • Vomiting or vomiting blood

Not all of these may occur, but medical attention is necessary.

Pradaxa vs. warfarin

Prior to the release of Pradaxa, a commonly used treatment was warfarin, also a blood thinner. There has been much debate over which drug performs better at treating atrial fibrillation as their interactions are significantly different.

Warfarin has been around for a number of decades and can be considered a veteran at treating blood clots, while Pradaxa is relatively new. Warfarin can be taken with Vitamin K to reverse internal bleeding and other adverse reactions but cannot be taken with many other medications. Pradaxa on the other hand can. In addition, warfarin requires frequent monitoring while Pradaxa does not.

Though warfarin and Pradaxa may treat atrial fibrillation differently, a new study published in the New England Journal of Medicine suggests there is no significant difference in treating another blood clot related condition known as venous thromboembolism (VTE), a combination of deep vein thrombosis and pulmonary embolism.

Pradaxa lawsuits

The FDA received a number of complaints alleging deadly adverse side effects including internal bleeding, uncontrolled bleeding, and stroke within weeks after approving Pradaxa in the U.S.

If you have suffered any of these adverse side effects after taking Pradaxa, you may want to contact an attorney today to have the facts of your case reviewed.


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