December 18, 2017

FDA gets request to approve Pradaxa reversal agent idarucizumab

Big news! Boehringer Ingelheim has submitted an application to the FDA requesting accelerated approval for idarucizumab, the reversal agent for Pradaxa (dabigatran). See: Boehringer Ingelheim Submits Biologics License Application to FDA for Idarucizumab*, Investigational Specific Reversal Agent for Pradaxa® Additionally, they have submitted for marketing approval by Health Canada and the European Medicines Agency (EMA). See: Boehringer […]

FDA Warning: Pradaxa Should Not Be Used by Atrial Fibrillation Patients with Mechanical Heart Valves

Good to see the FDA moving on this as we’re starting to hear of afib patients with mechanical heart valves getting Pradaxa. Here is the FDA announcement… ISSUE: The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be used […]

Vote Yes to Ask the FDA to List Vitamin K on Food Labels

At the American College of Cardiology meeting last week, I discovered a neat project being tackled by Alere, the sponsor of, which is a web site we highly recommend for those taking Coumadin or warfarin. If you take warfarin or Coumadin, you know that you have to keep your vitamin K intake consistent, but […]

FDA Panel Says Bipolar Radiofrequency Surgical Ablation Effective for Persistent Atrial Fibrillation

An FDA advisory panel voted that the overall benefits outweighed the risks in afib ablations using the AtriCure Synergy bipolar radiofrequency clamp. This was based on the results of the ABLATE clinical trial for ablation of persistent or longstanding persistent atrial fibrillation during other heart surgery. The panel recommended that the FDA approve it, setting […]

FDA Approves Alternative to Warfarin — Rivaroxaban (Xarelto) Approved for Atrial Fibrillation Stroke Prevention

The US Food and Drug Administration has approved Xarelto (rivaroxaban) to reduce stroke risk in those with non-valvular atrial fibrillation (afib unrelated to heart valve problems). Xarelto is now the second oral alternative to warfarin (Coumadin) and offers an option for those unable to take warfarin or dabigatran. Xarelto is the first once-a-day alternative to […]

Breaking News: FDA Panel Recommends Approval of Rivaroxaban (Xarelto) for Atrial Fibrillation Stroke Prevention

The US Food & Drug Administration (FDA) Advisory Committee just voted 9-2, with 1 abstaining, to recommend that the FDA approve rivaroxaban (Xarelto) for prevention of atrial fibrillation strokes. See our full story, now up at: FDA Panel Votes for Rivaroxaban: Atrial Fibrillation Patients May Soon Have Two Alternatives to Warfarin for Stroke Prevention

Rivaroxaban (Xarelto) Effective for Atrial Fibrillation Patients with High Stroke Risk

Just ahead of the FDA Advisory Committee hearing on rivaroxaban for stroke prevention in atrial fibrillation, we report in more depth on the ROCKET-AF trial results published recently in the New England Journal of Medicine. Rivaroxaban was shown to be as effective as warfarin (Coumadin) for stroke prevention in a high-risk afib population. To learn […]

Congress Embarks on Efforts to Cut the Deficit — Guest Post by WomenHeart

Note: In meetings with the FDA last week, representatives from WomenHeart and became aware of the risk that potential funding cuts may significantly delay the FDA’s work in reviewing and approving afib drugs and devices. Because of the potential impact on the afib community, we are publishing comments from WomenHeart as to what those […]

Breaking News: FDA Panel Unanimously Recommends Approval of Dabigatran to Decrease Stroke Risk in Atrial Fibrillation

An FDA panel today unanimously recommended that the FDA approve dabigatran (Pradaxa) for reducing the risk of afib strokes. FDA approval is expected quickly, making this the first alternative to warfarin approved in the United States, and also the first atrial fibrillation approval for dabigatran. It is approved in over 70 countries for venous thromboembolisms […] applauds FDA approval of Multaq® (dronedarone), a safer option to amiodarone for atrial fibrillation (afib) patients

We hear from so many afib patients every day about the trials, tribulations, and fears regarding being on amiodarone, or their refusal to take it. Since the FDA approved Multaq® (dronedarone) recently, the most frequent question I’ve fielded has been “When will Multaq® be available?” That happened this week, and the excitement they have shared […]