A discussion of the controversies surrounding the RE-LY and ROCKET-AF trials, which led to the initial FDA approvals of dabigatran (Pradaxa) and rivaroxaban (Xarelto) respectively.
Original RE-LY Trial: http://www.ncbi.nlm.nih.gov/pubmed/19717844
Original ROCKET-AF Trial: http://www.ncbi.nlm.nih.gov/pubmed/21830957
BMJ Criticisms of Dabigatran RE-LY:
http://www.ncbi.nlm.nih.gov/pubmed/25056265
http://www.ncbi.nlm.nih.gov/pubmed/25055831
http://www.ncbi.nlm.nih.gov/pubmed/25055829
BMJ Criticism of ROCKET-AF and Rivaroxaban:
http://www.ncbi.nlm.nih.gov/pubmed/26843102
Recent media coverage of dabigatran and RE-LY:
https://www.washingtonpost.com/news/federal-eye/wp/2015/10/15/fda-was-lax-and-kowtowed-to-drugmaker-in-review-of-controversial-blood-thinner-watchdog-says/
http://www.nytimes.com/2014/02/08/business/new-emails-in-pradaxa-case-show-concern-over-profit.html
http://www.nytimes.com/2014/02/06/business/study-of-blood-clot-drug-pradaxa-unnerved-its-maker-documents-suggest.html
Recent media coverage of rivaroxaban and ROCKET-AF:
http://www.nytimes.com/2016/02/23/business/fda-asks-if-faulty-blood-monitor-tainted-xarelto-approval.html?_r=0
http://www.cbsnews.com/news/did-heart-drug-makers-withhold-data-from-medical-journal/
Tagged under: anticoagulation,anticoagulant, ifb,atrial fibrillation,xarelto,dabigatran,noac,doac,tsoac,rivaroxaban,pradaxa,eliquis,edoxaban,xa inhibitor,direct thrombin inhibitor,warfarin,coumadin
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