Quoted from http://health.usnews.com/health-news/news/articles/2012/12/20/fda-dont-use-pradaxa-blood-thinner-in-patients-with-artificial-heart-valves
FDA: Don't Use Pradaxa Blood Thinner in Patients With Artificial Heart Valves
Warning based on European trial showing increased risk for strokes, heart attacks in this groupDecember 20, 2012
THURSDAY, Dec. 20 (HealthDay News) -- The blood thinner Pradaxa should not be used to prevent stroke or blood clots in patients with mechanical heart valves, the U.S. Food and Drug Administration said in a warning issued Wednesday.
As the agency noted, a clinical trial in Europe was halted recently because patients taking Pradaxa (dabigatran) were more likely to suffer strokes, heart attacks and clots forming on their mechanical heart valves than patients who were taking the older blood thinner warfarin.
Patients in the study who were taking Pradaxa also had more bleeding after valve surgery, the agency said.
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