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FDA Perspective Published In The New England Journal Of Medicine Reinforces Safety Of Pradaxa® (dabigatran Etexilate Mesylate)

RIDGEFIELD, Conn., March 18, 2013 /PRNewswire/ -- A new perspective from the U.S. Food and Drug Administration (FDA) states the agency has not changed its recommendations regarding Pradaxa ® (dabigatran etexilate mesylate) capsules, following the November 2012 Mini-Sentinel evaluations. The FDA stated that bleeding rates associated with new use of PRADAXA do not appear to be higher than those with new use of warfarin, which is consistent with observations from the pivotal RE-LY ® trial. The perspective was published online on March 13, 2013 in the New England Journal of Medicine (NEJM).

The Mini-Sentinel evaluated information about the risk of serious bleeding associated with the use of blood thinners (anticoagulants): PRADAXA and warfarin. The FDA investigated the rates of bleeding occurring in the stomach and intestines (gastrointestinal bleeding) and a type of bleeding in the brain (intracranial hemorrhage) for new users of PRADAXA compared to new users of warfarin. This assessment was done using insurance claims and administrative data from the FDA's ongoing Mini-Sentinel pilot of the Sentinel Initiative.

"We are encouraged that this article in NEJM provides important context about the safety of PRADAXA, reaffirming the findings from the pivotal RE-LY trial and the important health benefit of PRADAXA when used as directed," said Sabine Luik, M.D., Sr. Vice President, Medicine & Regulatory Affairs, U.S. Regional Medical Director, Boehringer Ingelheim Pharmaceuticals, Inc. 

About Pradaxa ® (dabigatran etexilate mesylate) CapsulesIndications and UsagePradaxa ® (dabigatran etexilate mesylate) capsules is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.


CONTRAINDICATIONSPRADAXA is contraindicated in patients with:
  • Active pathological bleeding
  • A known serious hypersensitivity reaction to PRADAXA (e.g., anaphylactic reaction or anaphylactic shock)
  • A mechanical prosthetic heart valve 


PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding. Promptly evaluate any signs or symptoms of blood loss (e.g., a drop in hemoglobin and/or hematocrit or hypotension). Discontinue PRADAXA in patients with active pathological bleeding.

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