FDA approves BI's Pradaxa

SILVER SPRING, Md. The Food and Drug Administration approved a drug for preventing strokes and blood clots in patients with abnormal heart rhythm, the agency said Tuesday.

The FDA announced the approval of Pradaxa (dabigatran etexilate) capsules, an anticlotting drug made by Boehringer Ingelheim for patients with atrial fibrillation, a type of abnormal heart rhythm that affects more than 2 million Americans.

“People with atrial fibrillation are at a higher risk of developing blood clots, which can cause a disabling stroke if the clots travel to the brain,” said Norman Stockbridge, director of the FDA Division of Cardiovascular and Renal Products.