New Atrial Fibrillation Drug Pradaxa Approved

Pradaxa May Prevent More Strokes Than Warfarin

Medically Reviewed by Laura J. Martin, MD on October 20, 2010
From the WebMD Archives

Oct. 20, 2010 -The FDA has approved Pradaxa, a new drug to prevent blood clots in patients with atrial fibrillation.

In a clinical trial, patients on Pradaxa had fewer strokes than those on warfarin (Coumadin, Jantoven).

"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," Norman Stockbridge, MD, PhD, director of the FDA's division of cardiovascular and renal products, says in a news release.

Many people with atrial fibrillation take warfarin, which requires frequent monitoring with blood tests. Such monitoring is not necessary with Pradaxa.

Like other anti-clotting drugs, however, Pradaxa can have adverse effects, including life-threatening bleeding. Other side effects may include gastrointestinal symptoms (including dyspepsia, an unpleasant feeling in the stomach), stomach pain, nausea, heartburn, and bloating.

The drug will be distributed with a medication guide explaining the risk of serious bleeding. Patients will get a copy of the guide every time they fill or refill a Pradaxa prescription.

Pradaxa's generic name is dabigatran etexilate. It is made by Boehringer Ingelheim Pharmaceuticals.