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: Bleeding

  • NO FDA Approval Yet for Andexanet

    Stephan Moll, MD writes… The FDA did NOT approve Andexanet (brand names: AndexXa™ in the US, IndexXa™ in Europe) in a decision on August 18th, 2016.  Andexanet is the antidote in clinical development to reverse the anticoagulant effect of Eliquis® (rivaroxaban), Savaysa® (edoxaban), Xarelto® (rivaroxaban) and Lovenox® (enoxaparin).  The FDA is said to have requested more information from…

  • Heavier Menstrual Bleeding on Xarelto?

    Stephan Moll, MD writes… Interesting and noteworthy observations published in the last 2 weeks:  Heavy menstrual bleeding appears to occur more commonly with Xarelto® than with warfarin [ref 1] and may be also more common with Xarelto® than with Eliquis® [ref 2].

  • Contraceptive Use While on Anticoagulants is Safe

    Stephan Moll, MD writes… Interesting and clinically relevant publication this week [ref 1].  It is well known that estrogens and certain progestin preparations increase the risk for venous thromboembolism (VTE).  A woman on an anticoagulant may have heavy menstrual bleeds and hormonal therapy – such as estrogen-progestin contraceptives – may be considered to decrease the bleeding.…

  • Bleeding on Antithrombotics: Reversal Protocol 2016

    Stephan Moll, MD writes…  Our medical center (University of North Carolina Hospitals,  Chapel Hill)  has put together a comprehensive “Emergent Anticoagulation Reversal Guideline” for our local use, updated since its last edition in 2014 with information about Pradaxa® reversal (with Praxbind®).  It is  a practical, clinical how-to document (2016 PDF here ). Colleagues and hospitals are welcome to take the…

  • 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.

  • LMWH and Epidural Catheters – FDA Recommendations

    Stephan Moll, MD writes… The FDA published today a drug safety recommendation to decrease bleeding and paralysis risk for patients receiving epidural catheters and being treated with LMWH  (detailed FDA report is here).  While in many parts of the document the FDA talks specifically about enoxaparin, the communication states that “these new timing recommendations….. will be added to the…

  • 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…