FDA Study Provides Some 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.

Click here to read the full post on Forbes.

 

Comments

  1. Thank you for scrutinizing the clinical trials processes of the FDA. In case you missed it, the Project On Government Oversight just published a report on dangerous decision making at the FDA, focusing on the agency’s handling of (the blood-thinner) Pradaxa: http://www.pogo.org/our-work/reports/2015/drug-problems-dangerous-fda-decision-making.html

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