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: FDA

  • Xarelto (Rivaroxaban) Approved For A. Fib

    Today the FDA approved Xarelto (Rivaroxaban) for atrial fibrillation.  The approved dose is 20 mg once daily. The link to the FDA press release is here.  The Xarelto prescribing information can be found here. Xarelto for Venous Thromboembolism Xarelto is NOT approved at this point for treatment of DVT or PE

  • Yasmin, Yaz and Other Drospirenone Contraceptives: Risk for VTE

    It has long been known that estrogen-containing birth control preparations (pill, patch, ring) increase the risk for DVT and PE (venous thromboembolism = VTE).  This risk is partially due to the estrogen.  However, part of the risk is also due to the type of progestin in these preparations.

  • Yasmin, Yaz, Angeliq and Risk for Blood Clots

    Birth control pills, patches and rings typically contain an estrogen and a progestin component.  It has long been known that estrogen-containing birth control preparations (pill, patch, ring) increase the risk for blood clots (DVT, PE).  This risk is partially due to the estrogen.  However, part of the risk for clots is also due to the…

  • Nattokinase

    Your patient may inquire whether he/she can take Nattokinase instead of staying on warfarin to prevent future venous thromboembolism; or what you think about the effectiveness of Nattokianse in preventing a first or recurrent DVT or PE.

  • Rivaroxaban (Xarelto): Advisory Board to the FDA Recommends Approval for Atrial Fibrillation

    The external advisory board to the FDA recommended today (Sept 8th, 2011) to approve Rivaroxaban (Xarelto) for the stroke prevention in atrial fibrillation.  More details about the vote can be found here.  Today’s recommendation is contrary to the one given by an internal FDA review committee which had recommended 2 days ago to NOT approve the…

  • Rivaroxaban (Xarelto): FDA Advisory Board Recommends Against Approval for Atrial Fibrillation

    Surprise to many people today:  An FDA staff report released today (Sept 6th, 2011) states that FDA reviewers recommend against the approval of rivaroxaban (Xarelto) for the atrial fibrillation indication.  A detailed discussion with reasons for the recommendation can be found here.  The main reason: It has not been shown that rivaroxaban is as effective as…

  • Xarelto (Rivaroxaban) – FDA Approved

    Today the FDA approved the oral anticoagulant Xarelto (rivaroxaban) for DVT prevention in patients undergoing knee or hip replacement surgery.  This is good news