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FDA cautions against Pradaxa in patients with mechanical prosthetic heart valves
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The FDA is informing health care professionals and the public that dabigatran etexilate should not be used to prevent stroke or major thromboembolic events in patients with mechanical prosthetic heart valves.
A clinical trial in Europe — RE-ALIGN — was recently halted because patients assigned dabigatran (Pradaxa, Boehringer Ingelheim) were more likely to experience strokes, myocardial infarction and other thromboembolic events forming on the mechanical heart valves compared with patients assigned warfarin. There was also more bleeding after valve surgery in dabigatran users than in warfarin users, according to a drug safety communication.
Dabigatran is not approved for patients with atrial fibrillation caused by heart valve problems. The FDA is requiring a contraindication of the drug in patients with mechanical heart valves.
According to the FDA release: “Health care professionals should promptly transition any patient with a mechanical heart valve who is taking Pradaxa to another medication. Patients with all types of prosthetic heart valve replacements taking Pradaxa should take to their health care professional as soon as possible to determine the most appropriate anticoagulation treatment. Patients should not stop taking anticoagulant medications without guidance from their health care professional; stopping Pradaxa or other anticoagulants can increase the risk of blood clots and stroke.”
Adverse events related to dabigatran use can be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.