FDA Warns Against Use of Pradaxa in Mechanical Heart Valve Patients

WASHINGTON, D.C. — The Food and Drug Administration has warned the public and health care professionals that Boehringer Ingelheim’s blood thinner Pradaxa (dabigatran) should not be used to prevent blood clots in individuals with mechanical heart valves.

According to the Dec. 19 safety announcement, a clinical trial in Europe (the RE-ALIGN trial) was halted because Pradaxa users were more likely to have strokes, heart attacks and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users, the FDA …