The Pradaxa label was updated only four days ago, at the conclusion of the FDA’s study of the bleeding issue: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#labelinfo http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s014lbl.pdf