A Clearinghouse for Information about Blood Clots (DVT/)PE) and Clotting Disorders (thrombophilia) provided as a public service by the University of North Carolina Blood Research Center

Category: Pradaxa – dabigatran

  • FDA to Review Eliquis (Apixaban) for DVT and PE Treatment

    Stephan Moll, MD writes… On Dec 19th the FDA accepted the application by Bristol-Myers Squibb (BMS) and Pfizer for review of Eliquis (apixaban) for the treatment of DVT and PE. The press release of BMS is here.  The goal date for a decision by the FDA is August 25, 2014.

  • Handout for Your Patients in Clinic – Which Anticoagulant to Use for DVT and PE

    Stephan Moll, MD writes…  Patients who are on warfarin for a history of DVT or PE  may inquire whether a switch to one of the  new oral anticoagulants is appropriate.  Similarly, many physicians initiate this discussion with their patients. This is, obviously, a detailed discussion and an individualized decision with a number of factors to be considered.…

  • Major Bleeding on Dabigatran (Pradaxa) – Interesting Publication

    Stephan Moll, MD writes… Interesting publication this week in Circulation: “Management and outcomes of major bleeding during treatment with dabigatran or warfarin” (Majeed A et al; published online Sept 30,2013;  full publication is here).  The management and prognosis of major bleeding in patients treated with dabigatran or warfarin was compared, pooling data of the major bleeds that occurred in 5 phase III…

  • NEJM Publication: Edoxaban for VTE Treatment

    Stephan Moll, MD writes…  Today, Sept 1st, 2013, the New England Journal of Medicine published the phase 3 clinical trial of edoxaban versus warfarin in the treatment of DVT and PE [ref 1]. It showed that edoxaban was as effective as warfarin and led to less clinically relevant bleeding.

  • New Oral Anticoagulants for DVT and PE: Update on FDA Applications

    Stephan Moll, MD writes…   1.  Pradaxa (Dabigatran) Today, August 28th, 2013, it was announced that the FDA is reviewing the application by Boehringer-Ingelheim to get Pradaxa (dabigatran) approved for use in patients with deep vein thrombosis (DVT) and pulmonary embolism (PE) – details here. At present, in the US, Pradaxa is only FDA-approved for…

  • International Coagulation Meeting (ISTH 2013): Highlights

    Stephan Moll, MD writes…  A major international coagulation conference, the bi-annual meeting of the International Society for Thrombosis and Haemostasis (ISTH; http://www.isth.org), took place in Amsterdam, Holland, from June 29th to July 4th, 2013.  The clinically relevant highlights about thrombosis and anticoagulation are summarized below.

  • Top 10 Publications on Thrombosis and Anticoagulation from 2012

    Stephan Moll writes… 2012 has been a year with significant progress in the field of venous thromboembolism and anticoagulation.  The three most noteworthy, clinically relevant developments were probably (a) the publication of the new ACCP (American College of Chest Physician) guidelines on antithrombotic therapy in February 2012; (b)  The FDA-approval of rivaroxaban (Xarelto) in November 2012 for the acute…

  • Eliquis (Apixaban) News – Plus Update On The Big Four New Oral Anticoagulants

    There is a lot of appropriate interest and excitement today about one of the four new blood thinners in development – Apixaban (Eliquis). Data from the large atrial fibrillation trial called ARISTOTLE were published today and show that the drug is more effective and safer than warfarin in patients with atrial fibrillation [ref 1].  This…