UPDATED 11/02/2012. Results of FDAs Mini-Sentinel assessment indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin.
My comment -= I hope this review by the FDA reassures patients that the use of Pradaxa is safe as an alternative to warfarin,. This adds to the randomized trial RE-L. Patients are being unnecessarily frightened by TV ads by malpractice attorneys and decisions about options fro treatment are being complicated without reason.,