FDA panel approves of new stroke drug

Jenny Decker RN's picture

Although advisory panels can only make suggestions to the FDA, one panel voted unaminously to approve a new stroke drug that may be even more beneficial for those with atrial fibrillation than the commonly used drug warfarin. Members of the Food and Drug Administration advisory panel were convinced that Pradaxa, made by German drugmaker Boehringer Ingelheim, is superior to warfarin in preventing a stroke.


A decision on Pradaxa by the FDA is expected by October 19. It is considered to be both safe and effective and may even work better than warfarin in certain doses. The higher dose, 150 mg, is considered to be the dose of choice. At 110 mg, the study RE-LY found the drug to only be equal to warfarin.

Getting a head start in warfarin replacement war

If Pradaxa is approved in October, it will be getting a head start in the warfarin replacement war. Currently, at least eight drugs are being tested by major drug makers to replace warfarin. The market is predicted to be worth more than $10 billion a year, possibly $20 billion a year.

So what is the big deal in replacing warfarin (Coumadin)? Well, warfarin interacts adversely with some foods and other medications. It is also difficult to regulate without frequent blood tests and it carries a high risk of bleeding, as well. Though Pradaxa does carry a risk of bleeding, the risk is not as high as with warfarin.
Other companies currently testing drugs are Bayer, Johnson & Johnson, Daiichi Sankyo, Bristol-Meyers, and Merck and Co’s. Warfarin is used to treat Americans who have atrial fibrillation, but Pradaxa is already in use in Canada and Europe.