Pradaxa Approved for Atrial Fibrillation10/20/10
WEDNESDAY, Oct. 20 (HealthDay News) -- Pradaxa (dabigatran
etexilate) has been approved by the U.S. Food and Drug
Administration to help prevent stroke in people with a type of
abnormal heart rhythm called atrial fibrillation.
The condition, which occurs when the heart's two upper chambers
beat quickly and out of sync, affects more than 2 million
Americans, the agency said in a news release.
Pradaxa is an anti-clotting drug that inhibits an enzyme
involved in blood clotting. Clinical studies of the drug found that
when compared with the popular anticoagulant warfarin, people with
atrial fibrillation had fewer strokes on Pradaxa than those on
warfarin, the FDA said.
As with other anti-clotting drugs, a potential side effect is
life-threatening bleeding, the agency said. Other potential adverse
reactions include stomach discomfort or pain, nausea, heartburn and
Pradaxa is produced in 75 milligram and 150 milligram strengths
by Boehringer Ingelheim Pharmaceuticals, based in Ridgefield,
The American Heart Association has more about
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