An 85-year-old woman with a history of hypertension and Crohn’s disease presented with severe pain in the left hand and was admitted to the hospital. Examination revealed a diminished left-radial pulse; arterial Doppler imaging showed a thrombus in the radial artery. The patient underwent surgical thrombectomy. The workup, including a hypercoagulability profile, was negative. Transthoracic…

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Following the approval last October of dabigatran, some observers criticized the FDA’s decision not to approve the lower 110 mg dose of the drug in addition to the higher 150 mg dose. Now, in a perspective in the New England Journal of Medicine, 3 FDA officials — B. Nhi Beasley, Ellis Unger, and Robert Temple — explain…

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The FDA has issued a safety communication regarding dabigatran (Pradaxa). Because the drug is subject to product breakdown and loss of potency due to moisture, the FDA recommends that it should be dispensed and stored in its original packaging and that consumers avoid using pill boxes or pill organizers with it. Pradaxa is supplied as…

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In a series of blog posts on CardioExchange, Samuel Goldhaber, Director of the Venous Thromboembolism Research Group in the Cardiovascular Division at Brigham and Women’s Hospital, has been guiding us on best practices around dabigatran. Recently, he teamed up with Elaine Hylek, Director of the Thrombosis and Anticoagulation Service at Boston University School of Medicine,…

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CardioExchange welcomes Samuel Zachary Goldhaber, MD, Director of the Venous Thromboembolism Research Group and Medical Co-Director of the Anticoagulation Management Service at Brigham and Women’s Hospital in Boston. He answers practical questions from the CardioExchange editors about newly updated recommendations on the use of dabigatran in patients with atrial fibrillation, issued by the American College…

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Less than two months after the publication of the 2010 updated atrial fibrillation (AF) guidelines, the AHA, the ACC, and the HRS have released a new focused update incorporating recommendations and a discussion concerning the direct thrombin inhibitor dabigatran, which gains a Class I recommendation: Class I: Dabigatran is useful as an alternative to warfarin…

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A substudy of the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial demonstrates that dabigatran is as effective in AF patients for secondary stroke prevention as it is for overall stroke prevention. In their paper in the Lancet Neurology, Hans-Christoph Diener and the RE-LY study group report the results of the trial in the predefined…

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Dabigatran, newly approved by the FDA to prevent stroke in patients with atrial fibrillation (AF), might turn out to be a cost-effective alternative to warfarin, according to an Annals of Internal Medicine study. Using data from the RE-LY trial, James Freeman and colleagues modeled the quality-adjusted survival and cost-effectiveness of dabigatran compared with high- or low-dose warfarin…

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It looks like Pradaxa (dabigatran) will cost about $237 a month at the drugstore counter. A Boehringer Ingelheim representative says the wholesale acquisition cost (WAC) of the drug is set at $6.75 per day for 2 pills. The price will apply to both the 150-mg and the 75-mg capsules.  According to knowledgeable experts, the retail…

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These four patients are receiving chronic anticoagulation therapy. Read the descriptions of their cases and decide which, if any, of them you would switch to dabigatran. Case 1 A 69-year-old man with a history of hypertension and colon cancer was found to be in atrial fibrillation during a preoperative assessment for colon resection. Metoprolol was…

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