Heart Disease

Heart Disease

Pradaxa Bleeding and Higher Heart Attack Risk?

Currently, Pradaxa’s drug label already contains a warning about significant and sometimes fatal bleeds. In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs.

FDA is also working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa. FDA is working closely with Pradaxa’s maker to evaluate the post-market reports of bleeding.