Patient Education Blog

FDA-Approval for Pradaxa (dabigatran) for DVT and PE

Stephan Moll, MD writes…  Today the FDA approved Pradaxa (dabigatran) for the treatment of DVT and PE.  Thus, two of the new oral blood thinners are now FDA-approved for the treatment of DVT and PE:  Xarelto (rivaroxaban) and Pradaxa (dabigatran).  Due to the design of the clinical trials that lead to the FDA approval, Pradaxa should NOT be given immediately when DVT or PE are diagnosed, but rather after 5-10 days of treatment with an injectable blood thinner (into the skin or a vein; such as Lovenox = enoxaparin; Fragmin = dalteparin; Innohep = tinzaparin; or heparin).  A Clot Connect summary of the FDA approval status of the four big new oral blood thinners for the various indications is in this table.  Pradaxa’s full medication package insert is here.  Today’s press release from Boehringer-Ingelheim about the FA approval is here.


Disclosures:  I have been a consultant for Boehringer-Ingelheim,  Daiichi, and Janssen.

Last updated:  April 7th, 2014

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