FDA Safety Alert: Pradaxa May Cause Blood Clots on Mechanical Heart Valves
If you have a mechanical prosthetic heart valve, the FDA is warning patients not to use Pradaxa to treat atrial fibrillation. In fact, the FDA says that Pradaxa should not be used in patients who have atrial fibrillation caused by heart valve problems.
According to a report issued by the Institute for Safe Medication Practices, researchers stopped a recent clinical trial involving Pradaxa after blood clots (and resulting heart attack or stroke) were discovered to form on the mechanical heart valve.
As a result, the FDA recommends that health care professionals transition patients with mechanical heart valves off Pradaxa to another medication. Of course, if you have a mechanical heart valve and you're currently taking Pradaxa, you should only stop use or transition to another medication after first consulting with your health care professional.
About the Institute for Safe Medication Practices
The Institute bills itself as the country's only nonprofit dedicated to preventing medication errors. It's been doing this work since 1975, and continues to provide patients and health care professionals with an error-reporting program and regular safety alerts.