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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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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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Eliquis (Apixaban) 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 blood thinners in development – Apixaban (Eliquis). Data from the large atrial fibrillation trial called ARISTOTLE were published today and show that the drug is more effective and safer than warfarin in patients with atrial fibrillation [ref 1]. This…
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Xarelto (Rivaroxaban) – FDA Approved
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Xarelto (Rivaroxaban) – FDA Approved
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Xarelto® – Good News
Summary Good news. A major study published in December 2010 in the New England Journal of Medicine (NEJM) shows that the new oral “blood thinner” Xarelto® (=Rivaroxaban) is (a) as safe and effective as warfarin in patients with acute DVT, and (b) is quite effective in preventing recurrent venous thromboembolism if taken longer-term, with an…
