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Dabigatran (Pradaxa) Should NOT be used in Mechanical Heart Valve Patients

Henry I. Bussey, Pharm.D.
Marie Bussey
January, 2013

The FDA recently released a drug safety communication indicating that dabigatran (Pradaxa) should not be used in patients who have a mechanical prosthetic heart valve. The complete communication is available on the FDA website at

The communication specifically advises that "[h]ealth care professionals should promptly transition any patient with a mechanical heart valve who is taking Pradaxa to another medication....Patients should not stop taking anticoagulant medications without guidance from their health care professional; stopping Pradaxa or other anticoagulants suddenly can increase the risk of blood clots and stroke."

This safety communication issued by the FDA comes after Boehringer Ingelheim's RE-ALIGN study was stopped early due to concerns about valve thrombosis with dabigatran. To read more about the early termination of this study, go to

Although no results from the RE-ALIGN were available on as of January 27, 2013, a December 20, 2012 warning letter from Boehringer-Ingelheim (BI) and the updated package insert provide additional data about the trial, which was done outside of the U.S. in patients who had bileaflet mechanical heart valves. Reportedly, thromboembolic events (including stroke, transient ischemic events, valve thrombosis, and myocardial infarction) and major bleeding (mainly post-operative pericardial effusions that required intervention) were more common with dabigatran than with warfarin. The study included 3 dosages of dabigatran (150 mg, 220 mg, and 300 mg twice daily), but no information was provided on the relationship of dabigatran dose to either bleeding or clotting events. Reportedly, the increase in complications was seen with those who had newly implanted valves as well as those who entered the trial more than 3 months after valve implantation.

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