WebMD Medical News
Daniel J. DeNoon
Laura J. Martin, MD
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.
SOURCE:News release, FDA.
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