February 24, 2018

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 […]

Do you have atrial fibrillation? Your input can help shape research to benefit afib patients.

Patients with atrial fibrillation are at higher risk of suffering stroke and other complications related to the development of blood clots in their heart. Until 2010, the only oral anticoagulant (blood thinner) to prevent strokes in Afib was warfarin (Coumadin®). Now there are two new oral anticoagulants available in the United States–dabigatran (Pradaxa®) and rivaroxaban […]

Atrial Fibrillation & Anticoagulants–StopAfib.org interviews Dr. Daniel Singer

StopAfib.org interviews Dr. Daniel Singer of Harvard Medical School. Find more information on this topic, and Dr. Singer, at: http://www.stopafib.org/newsitem.cfm/NEWSID/397 Dr. Singer led a symposium on atrial fibrillation stroke prevention at Boston Atrial Fibrillation Symposium 2012. In this video interview, Dr. Singer shared with StopAfib.org information from that symposium. He provided an update on rivaroxaban […]

Atrial Fibrillation & Anticoagulants–StopAfib.org interviews Dr. Elaine Hylek

StopAfib.org interviews Dr. Elaine Hylek of Boston University. A transcript of this video, as well as additional information about the topics discussed, and Dr. Hylek, can be found at: http://www.stopafib.org/newsitem.cfm/NEWSID/349 In this video interview, Dr. Elaine Hylek of Boston University discusses new anticoagulant drugs for stroke prevention in atrial fibrillation. For many years, warfarin (Coumadin) […]

What Everyone with Atrial Fibrillation Should Know about Multaq (dronedarone)

As a patient, you probably see lots of hype-filled reports about various drugs. After a drug is approved, there’s an inevitable blitz of negative publicity which often scares people away from important new solutions that could help them. There has been so much news lately about Multaq (dronedarone), the drug designed to provide the benefits […]

Dr. Elaine Hylek on Xarelto and Pradaxa, New Alternatives to Warfarin (Coumadin) — Video

The US FDA has just announced that on September 8, 2011, the FDA Cardiovascular and Renal Drugs Advisory Committee will meet to review whether to recommend approval of rivaroxaban (brand name Xarelto), an alternative to warfarin, for stroke prevention in atrial fibrillation. In this recent video interview, Dr. Elaine Hylek, a leading anticoagulant authority, discussed […]

Pradaxa (dabigatran) approved as alternative to warfarin for reducing atrial fibrillation stroke risk

The long-awaited alternative to Coumadin (warfarin) has just been approved by the US FDA. The FDA just approved Pradaxa (dabigatran) for use by those with atrial fibrillation for preventing afib-related strokes. The FDA based approval on results of the RE-LY trial, which saw patients on Pradaxa having fewer strokes than those on warfarin. And Pradaxa […]

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 […]

@stopafib to live-tweet from FDA hearing on Dabigatran to replace warfarin for afib

Next Monday, September 20, 2010, StopAfib.org will be covering the FDA’s hearing on dabigatran (Pradaxa), the new alternative to warfarin, and will be “live-tweeting” from the hearing. Get first reports as they happen by following @stopafib on Twitter. If you’re already on Twitter, just follow us from the toolbar at the bottom of this page. […]