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FDA Declares Pradaxa and Warfarin Equal in Bleeding Risk

By November 15, 2012November 1st, 2017Pharmaceutical litigation, Pradaxa, Uncategorized

Pradaxa Lawsuit Bleeding Risk MDLIn early November, the U.S. Food and Drug Administration (FDA) released a statement about its recent research into the incidence of excessive bleeding and Pradaxa use in patients with atrial fibrillation.

For the past year, the FDA has been reviewing insurance claims and numerous other data in coming to its recent conclusion in regards to the safety of Pradaxa. The FDA statement declares that Pradaxa, manufactured by the German pharmaceutical company Boehringer Ingelheim, and warfarin present a similar risk of serious, excessive bleeding.

Pradaxa is prescribed to patients suffering from atrial fibrillation. This health condition is marked by an irregular heart beat resulting in compromised blood flow throughout the body. Pradaxa, a blood-thinning medication, treats atrial fibrillation by preventing blood clots and stroke.

Boehringer Ingelheim intended for Pradaxa to represent a new generation of blood-thinning medications. Pradaxa was meant to be a much safer alternative to warfarin, which was introduced on the drug market in the 1950s and has since then become known for causing life-threatening side effects.

This latest FDA statement shows that the Pradaxa marketing campaign has clearly failed. Pradaxa still presents a significant health risk to patients suffering from atrial fibrillation, and is clearly not a better alternative to Warfarin.

What is more, even though the FDA does not consider the bleeding risks to be more serious for Pradaxa in comparison to Warfarin, there still is no way to reverse the effects of Pradaxa. To treat excessive bleeding in warfarin patients, the administration of vitamin K has always proven to be a panacea.However, in a recent New York Times article published in early November, it is mentioned that though there is an antidote for excessive bleeding in warfarin patients, there is no such cure for the same life-threatening situation in Pradaxa patients.

Though the FDA has declared equality, there clearly still remains a huge difference in regards to the safety of patients taking Pradaxa versus those taking Warfarin.

Pradaxa health risks include the following:

  • Excessive bleeding
  • Internal bleeding
  • Cerebral hemorrhage
  • Gastrointestinal bleeding
  • Death

If you, or a loved one, has sustained an unwarranted amount of pain and suffering due to the use of Pradaxa, you and your loved one may be entitled to receive compensation. Learn more by contacting an experienced Pradaxa lawyer at Carey Danis & Lowe.