FDA Study Offers Reassurance About Boehringer Ingelheim's Pradaxa

In the latest development in its ongoing review of the new oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim), the FDA today offered largely reassuring news about the sometimes controversial drug. The FDA study of 134,000 Medicare patients found that dabigatran was associated with a reduced risk for ischemic stroke, bleeding in the brain, and death, compared to warfarin. But the study also found that, dabigatran was associated with an increased risk for major gastrointestinal bleeding. There was no difference between the drugs in the risk of MI.
Source: Forbes.com Healthcare News - Category: Pharmaceuticals Authors: Source Type: news