Posts Tagged ‘dabigatran’

September 12th, 2011

Global Monitor: Early Signs of Possible Problems with ICD Leads, Dabigatran

Reports from Ireland and New Zealand may herald new concerns about Riata defibrillator leads (St. Jude Medical) and dabigatran (Pradaxa). A poster presented at the European Society of Cardiology meeting last month by researchers at the Royal Victoria Hospital in Belfast found that 15% of 212 patients who received Riata leads had an insulation breach on screening. The researchers reported that […]


September 6th, 2011

FDA Reviewers Recommend Complete Response Letter for Rivaroxaban (Xarelto)

FDA reviewers have recommended against the approval of rivaroxaban (Xarelto, Johnson & Johnson), which will be the subject of a Cardiovascular and Renal Drugs Advisory Committee meeting on Thursday. The recommendation comes as a surprise, as many physicians and analysts had expected an easy approval for the drug. The bottom line from the FDA reviewers is […]


August 30th, 2011

Is Warfarin Still the First Choice in Atrial Fibrillation?

There’s an old maxim in medicine that one shouldn’t be the first to prescribe a new drug, nor the last. A fascinating debate between Michael Ezekowitz from the U.S. and Felicita Andreotti from Italy highlighted the differences between warfarin and the newer oral anticoagulants (NOACs) apixaban, rivaroxaban, and dabigatran. Even Dr. Ezekowitz, the warfarin protagonist for purposes […]


August 28th, 2011

ARISTOTLE Finds the Golden Mean of Anticoagulation

In ancient Greece the philosopher Aristotle thought the golden mean was the desirable middle between two extremes, one of excess and the other of deficiency. In cardiology, apixaban may be the golden mean of anticoagulation, achieving the ideal balance of reduced strokes and deaths without causing any additional bleeding complications. The Apixaban for Reduction in Stroke and Other […]


July 14th, 2011

Rivaroxaban: The Next Non-Warfarin Oral Blood Thinner

An electrophysiologist and blogger places the recent approval of rivaroxaban in the context of the seismic changes that have taken place and that are still expected in the anticoagulant marketplace.


July 14th, 2011

Recurrent Arterial Thrombosis plus GI Bleeding in an Elderly Woman

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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 […]


April 14th, 2011

FDA Officials Offer Explanation for Absence of Low-Dose Dabigatran

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 […]


March 30th, 2011

FDA Warns Against Repackaging Dabigatran

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 either […]


March 18th, 2011

Dabigatran Dialogue: Two Experts Answer Our Questions and Yours

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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, […]


February 15th, 2011

Dabigatran for Patients with AFib: Putting the Updated Recs into Practice

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 […]