Sunday, November 7, 2010

FDA approves Pradaxa to prevent stroke in people with atrial fibrillation....

We knew that, Dabigatran (see structure, Pradaxa in Europe and USA, Pradax in Canada) is an anticoagulant from the class of the direct thrombin inhibitors. It is being studied for various clinical indications and in many cases it offers an alternative to warfarin as the preferred orally administered blood thinner since it does not require prothrombin time monitoring while offering similar results in terms of efficacy. It was developed by the pharmaceutical company Boehringer Ingelheim. Though it was approved in Europe in 2008, now FDA has approved the drug in October 2010 for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).

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 anticoagulant warfarin. In the trial, patients taking Pradaxa had fewer strokes than those who took warfarin.

 "Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa," Dr. Norman Stockbridge(director of the Division of Cardiovascular and Renal Products in the FDA's ) says.

Pradaxa, manufactured by Boehringer Ingelheim Pharmaceuticals Inc. of Ridgefield, Conn., will be available in 75 milligram and 150 milligram capsules....

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