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FDA Approves Praxbind (idarucizumab) as a Reversal Agent for the Anticoagulant Pradaxa

Posted 19 Oct 2015 by Drugs.com

October 16, 2015 – The U.S. Food and Drug Administration today granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects. “The anticoagulant effects of Pradaxa are important and life-saving for some patients, but there are situations where reversal of the drug’s effects is medically necessary,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval offers the medical community an important tool for managing patients taking Pradaxa in emergency or life-threatening situations when bleeding can’t be controlled.” The FDA approved Pradaxa in 2010 to prevent stroke and systemic blood clots in patients with atrial fibrillation, ... Read more

Related support groups: Pradaxa, Dabigatran, Praxbind, Reversal of Dabigatran, Idarucizumab

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