FDA Approves Pradaxa–An Alternative to Warfarin To Treat Blot Clots Associated With Atrial Fibrillation
Posted Oct 19 2010 4:40pm
In the clinical trials, fewer patients taking Pradaxa had blood clots than those taking warfarin and the there’s no monitoring needed, which is a big thing that has been discussed with warfarin for a number of years and even to the point to where genomics has entered the picture to help out.
Atrial fibrillation is a heart condition to where the 2 upper chambers beat abnormally and patients affected have a higher risk of blood clots. BD
SILVER SPRING, Md., Oct. 19 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).
"Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa," Stockbridge says.
As with other approved anti-clotting drugs, bleeding, including life-threatening and fatal bleeding, was among the most common adverse reactions reported by patients treated with Pradaxa. Gastrointestinal symptoms, including an uncomfortable feeling in the stomach (dyspepsia), stomach pain, nausea, heartburn, and bloating also were reported.
Pradaxa, manufactured by Boehringer Ingelheim Pharmaceuticals Inc. of Ridgefield, Conn., will be available in 75 milligram and 150 milligram capsules.