(WASHINGTON) -- The U.S. Food and Drug Administration Tuesday approved a new blood thinner called Pradaxa, intended to prevent strokes and blood clots for people with irregular heart rhythms.
At least one trial has found Pradaxa to be more effective than the blockbuster blood thinner Coumadin (warfarin).
"Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring in not necessary for Pradaxa," said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research.
The FDA warns that just as with other anti-clotting drugs, patients taking Pradaxa may be at risk for bleeding, including life-threatening and fatal bleeding. Stomach pain, nausea, heartburn and bloating are also among the reported side effects.
Pradaxa is manufactured by Boehringer Ingelheim Pharmaceuticals Inc. of Ridgefield, Connecticut.
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