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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…
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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…
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Minor Cuts and Nosebleeds on Anticoagulants
When a patient on warfarin bleeds more than usual it is, of course, important to make sure that the INR is not supra-therapeutic. And, if the INR is too high, warfarin therapy needs to be adjusted and other treatment (vitamin K, etc) may have to be employed depending on the degree of INR elevation and…
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Apixaban (Eliquis) 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 oral anticoagulants in development – Apixaban (Eliquis). Data from the large ARISTOTLE trial were published today in the NEJM, showing that in patients with atrial fibrillation Apixaban was more effective in preventing stroke and systemic thromboembolism, caused less major bleeding, and resulted…
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Pregnancy and Venous Thromboembolism: Prevention, Diagnosis, Treatment
A new guideline about the prevention, diagnosis, and treatment of DVT and PE associated with pregnancy was published today by ACOG (American College of Obstetricians and Gynecologists) in its respected series of Practice Bulletins. The bulletin includes detailed reference to thromboprophylaxis in pregnant women with thrombophilia.
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Prescription assistance: when you can’t afford a medication
Beth Waldron, Program Director of the Clot Connect project, writes…. Approximately 1 in 5 people don’t take a medication a doctor has prescribed because they can’t afford to pay for it [ref 1]. While the cost of some outpatient “blood thinning” therapies (anticoagulants) can be substantial, failure to take a blood thinning medication as prescribed…
