Pradaxa

A review by the FDA finds no additional risk of myocardial infarcation (MI) or a heart attack when Pradaxa (dabigatran) is compared to Coumadin (warfarin). An MI occurs when blood suddenly stops flowing to parts of the heart injuring the heart muscle. This latest study is trying to push Pradaxa as the drug […]

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 […]

This report is confusing to the many people who know from experience that taking the anticoagulant Pradaxa (dabigatran) is more dangerous than warfarin (Coumadin), the treatment that’s been the standard of care for decades. According to a published perspective in the online March 14, New England Journal of Medicine (NEJM), […]

Boehringer Ingelheim, a German drug company and maker of the blood thinner Pradaxa, must pay the federal government $95 million in compensation for defrauding Medicare. The government charged that Boehringer Ingelheim promoted their drug “off label” meaning for uses they had not received regulatory approval by the U.S. Food and […]

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 […]

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, […]

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 […]

Published today in the Journal of Neurosurgery is a shocking report detailing the death of an elderly gentleman who had begun taking Pradaxa (Dabigatran) just one month earlier. Three University of Utah doctors (Garber, Sivakumar and Schmidt) report that the man died from catastrophic, irreversible brain hemorrhage after suffering a […]

In yet another embarrassing moment for our United States regulatory authorities and medical establishment, doctors in New Zealand have written an open letter published in the New England Journal of Medicine highlighting the extreme danger posed by the drug Pradaxa. As we have written before, Pradaxa is Takeda Pharmaceutical’s solution […]

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 […]