FDA approves drug for patients with heart defect

AP News
Posted: Oct 19, 2010 7:32 PM
FDA approves drug for patients with heart defect

The Food and Drug Administration says it has approved a new pill to reduce the stroke risk in patients with irregular heartbeats.

The agency says it approved Pradaxa from German drugmaker Boehringer Ingelheim for patients with atrial fibrillation, a heart problem in which the heart's chambers do not properly contract.

More than 2 million patients in the U.S. have the condition, according to the FDA.

Until now most patients have been given warfarin, an older drug that has side effects including internal bleeding. In a study comparing Pradaxa to warfarin, patients taking the newer drug had fewer strokes.

Pradaxa is an anti-clotting drug that works by stopping the enzyme involved in blood clotting.

(This version CORRECTS Corrects name to 'Pradaxa' throughout; to 'strokes' in penultimate paragraph.)