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: Xarelto – Rivaroxaban

  • Pradaxa (Dabigatran) FDA-Approved for DVT and PE

    Stephan Moll, MD writes…  Today the FDA approved Pradaxa (dabigatran) for the treatment of venous thromboembolism, based on the phase 3 RECOVER and RECOVER II trials.  The dose is 150 mg twice daily for patients with a GFR > 30 ml/min.  Due to the design of the RECOVER and RECOVER II trials, the drug is approved…

  • Pregnancy, Breastfeeding – Safety of Various Anticoagulants

    Stephan Moll, MD writes… LMWH (low molecular weight heparin) is the preferred anticoagulant in the pregnant patient. LMWH and warfarin are safe in the woman who is beast-feeding. Rivaroxaban (Xarelto), dabigatran (Pradaxa) and apixaban (Eliquis) should not be used during pregnancy or while breastfeeding. A detailed summary about the safety of the various anticoagulants during pregnancy…

  • 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.…

  • 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.

  • Warfarin Failure

    Stephan Moll, MD writes… Occasionally, recurrent DVT or PE occur in spite of warfarin therapy, particularly in patients with (a) fluctuating and sub-therapeutic INRs, (b) lupus anticoagulant/ antiphospholipid antibody (APLA) syndrome or (c) cancer.