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A new perspective from the U.S. Food and Drug Administration (FDA) published in the New England Journal of Medicine1 states that the agency has not changed its recommendations regarding Pradaxaή (dabigatran etexilate), following the November 2012 Mini-Sentinel evaluations.2 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-LYή trial.1-4 The perspective was published online on March 13, 2013.1
The Mini-Sentinel evaluated new information about the risk of serious bleeding associated with the use of blood thinners (anticoagulants): Pradaxa and warfarin. The FDA investigated the actual rates of bleeding occurring in the stomach and intestines (gastrointestinal bleeding, GIH) and a type of bleeding in the brain (intracranial hemorrhage, ICH) for new users of Pradaxaή 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.
In the November 2012 Mini-Sentinel evaluations, the FDA stated: “For the populations in the Mini-Sentinel data assessment, the combined incidence rate (ICH and GIH events per 100,000 days at risk) was 1.8 to 2.6 times higher for new users of warfarin than for new users of Pradaxa,” and that “Pradaxaή provides an important health benefit when used as directed.”2
“We are encouraged that this article in the New England Journal of Medicine provides important context about the safety of Pradaxa, reaffirming the findings from the landmark RE-LYή trial and the important health benefit of Pradaxa when used as directed,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim.
Please click on the link below for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/26_march_2013_dabigatranetexilate.html