FDA Assessment Reinforces Safety Data of Pradaxa

FDA Assessment Reinforces Safety Data of Pradaxa

Tarrytown, NY November 2, 2012  – The National Blood Clot Alliance (NBCA) learned today, that the Food and Drug Administration’s (FDA) Mini-Sentinel assessment shows no increased bleeding risk in patients using Pradaxa (dabigatran). http://www.fda.gov/Drugs/DrugSafety/ucm326580.htm

Jack Ansell, MD, Chair of NBCA’s Medical and Scientific Advisory Board (Chair, Department of Medicine, Lenox Hill Hospital, NY) said that “FDA’s assessment indicates that bleeding rates associated with new use of Pradaxa does not appear to be higher than bleeding rates associated with new use of warfarin.”

FDA’s Mini-Sentinel assessment evaluated new information about the risk of serious bleeding associated with use of the anticoagulants (blood thinners) PRADAXA and warfarin. FDA investigated the actual rates of gastrointestinal bleeding (occurring in the stomach and intestines) and intracranial hemorrhage (a type of bleeding in the brain) 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.

Pradaxa was approved by the FDA in 2010 to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF).It was the first oral stroke risk reduction blood thinner as an alternative to warfarin.

NBCA President, Randy Fenninger said “this is good news for AF patients and healthcare professionals as they consider the benefits of the use of blood thinners.”

FDA said it will continue to monitor comparative safety data as part of the ongoing review of blood thinner safety for stroke prevention agents used by patients with AF.

Xarelto (Rivaroxaban), another oral anticoagulant was approved to reduce stroke risks in AF patients by FDA in 2011 .

Pradaxa is marketed by Boehringer Ingelheim Pharmaceuticals, Inc, based in Ridgefield, CT.

The National Blood Clot Alliance’s mission is to advance prevention, early diagnosis and successful treatment of blood clots, clotting disorders and clot-provoked strokes through public awareness, advocacy and patient and professional education.

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