According to the FDA, patients who have artificial heart valves should not use Pradaxa. The FDA issued this latest Pradaxa warning, after data from a clinical trial showed that the blood thinner may increase the risk of strokes, heart attacks, blood clots and other catastrophic bleeding problems.
Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems. FDA is requiring a contraindication (a warning against use) of Pradaxa in patients with mechanical heart valves.
The medical study was a clinical trial known as RE-ALIGN, and it was recently cancelled in Europe to protect patient safety. The medical researchers showed that using Pradaxa with mechanical heart valves increased the risk of heart problems and had a poorer outcome than using Coumadin or warfarin.