www.fdanews.com/articles/142678-fda-begins-safety-review-of-bleeding-with-bi-rsquo-s-pradaxa
FDA Begins Safety Review of Bleeding With BI’s Pradaxa
December 21, 2011
The FDA is reviewing postmarket reports of serious bleeding events in patients taking Boehringer Ingelheim’s blood-thinner Pradaxa just as the drug is facing increased competition with approval of Johnson & Johnson and Bayer’s Xarelto in atrial fibrillation (AF) patients.
Washington Drug Letter
Washington Drug Letter