FDA Approves Pradaxa to Prevent Stroke in People With Atrial Fibrillation

FDA 20 October 2010 approved Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).

FDA today (20 October 2010) approved Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).

Atrial fibrillation, which affects more than 2 million Americans, involves very fast and uncoordinated contractions of the heart’s two upper heart chambers (atria) and is one of the most common types of abnormal heart rhythm.

“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, MD, PhD, Director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research.

www.fda.gov

Pradaxa is an anticoagulant that acts by inhibiting thrombin, an enzyme in the blood that is involved in blood clotting. The safety and efficacy of Pradaxa were studied in a clinical trial comparing Pradaxa with the anticoagul