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

Tag: dabigatran

  • Antiphospholipid Syndrome: Can the New Oral Anticoagulants Be Used?

    Stephan Moll, MD and Damon Houghton, MD write … In patients with antiphospholipid syndrome (APS) who require anticoagulation for the treatment of DVT or PE, warfarin or a low molecular weight heparin have traditionally been used. A question that comes up is whether one of the new oral anticoagulants (DOACs) can be effectively and safely…

  • Reversal Agent for Pradaxa: Important NEJM Publication Today

    Stephan Moll, MD writes… A publication in the New England Journal of Medicine today reports on the use of the Pradaxa® (Dabigatran) antidote Idarucizumab in patients on Pradaxa® who present with major bleeding or require urgent surgery [ref 1]. 

  • Antidotes for the New Oral Anticoagulants: Update

    Stephan Moll, MD writes (on Nov 7th, 2014)… A N Engl J Med publication this week [ref 1] reports on a new reversal agent (PER977 = Aripazine = ciraparantag) that may be effective against a number of different new oral anticoagulants.

  • Apixaban (Eliquis) FDA-Approval for DVT and PE Treatment

    Stephan Moll, MD writes…  Apixaban (Eliquis®) was approved by the FDA this week (Aug 21, 2014) for the treatment of DVT and PE.  The approval covers (a) acute DVT/PE management and (b) prevention of recurrent DVT/PE.

  • 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…

  • 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.

  • 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…

  • 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…