Education Blog for Healthcare Professionals

Pradaxa (Dabigatran) FDA-Approved for DVT and PE

Stephan Moll, MD writes…  Today the FDA approved Pradaxa (dabigatran) for the treatment of venous thromboembolism, based on the phase 3 RECOVER and RECOVER II trials.  The dose is 150 mg twice daily for patients with a GFR > 30 ml/min.  Due to the design of the RECOVER and RECOVER II trials, the drug is approved to be used in the patient with acute DVT or PE only AFTER 5-10 days of a parenteral anticoagulant have been given –  not immediately from day zero onwards.   The full package insert is here.  The press release from Boehringer-Ingelheim is here.   The FDA approval status of the four big new oral anticoagulants for the various indications is summarized  in this table.

 

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

Last updated:  April 7th, 2014

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