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Category: Pradaxa

FDA Eyes Pradaxa Again

02/6/2014
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Despite all the company assurances that the anticoagulant Pradaxa is a superior alternative to warfarin, the Food and Drug Administration (FDA) plans to once again compare the two. Pradaxa was approved in 2010 but has since then brought a high complication rate to its users  – including dangerous and uncontrolled bleeding […]

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New Injury Linked to Pradaxa – Alveolar Hemorrhage

08/23/2012
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Physicians from American University in Lebanon published a case report regarding Pradaxa (dabigatran etexilate) that was published in the July 28, 2012, edition of the Journal of Thrombosis and Thrombolysis.  In this article, the authors wrote about an 85 year old patient who developed shortness of breath, anemia, and white […]

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Pradaxa Tops FDA’s List for Serious Adverse Events

06/26/2012
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According to an analysis by the Institute for Safe Medication Practices, Pradaxa drug (Dabigatran) topped the list of direct reports to the FDA for serious adverse drug events in 2011.  Pradaxa took the lead with 817 direct reports, followed by Coumadin (Warfarin) with 490 direct reports, Levaquin (Levofloxacin) with 393, […]

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Pradaxa’s Life in the FDA Fast Lane — Profits Over Safety?

05/11/2012
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Pradaxa, an anti-coagulant drug marketed by Boehringer Ingelheim Pharmaceuticals, enjoyed an unusually smooth (and quick) ride towards FDA approval.  Rather than spending months pouring over clinical studies and safety data, FDA employees instead approved Pradaxa based primarily on a single study and did so in just six months.  Below are […]

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Things You Should Know About Pradaxa (dabigatran)

01/19/2012
Common Questions
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A startling article entitled, “Conflict of Interest in the Assessment of Thromboprophylaxis” appeared in the January 2012 issue of The Journal of Bone & Joint Surgery. A group of investigators were curious about the possibility of bias during evidence-based reviews and they conducted a retrospective study, centering on prescription choice […]

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