Pradaxa label updated with contraindication

Pradaxa label updated with contraindication
Pradaxa label updated with contraindication

HealthDay News - The anticoagulant dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim) should not be used to prevent stroke or blood clots in patients with mechanical heart valves, the FDA warned in a safety announcement.

Recently, the phase 2 RE-ALIGN study was stopped early when results from an interim analysis showed dabigatran etexilate mesylate increased patients' risk for major thromboembolic events, including strokes, heart attacks and blood clots, compared with the anticoagulant warfarin.

"The FDA is requiring a contraindication of Pradaxa in patients with mechanical heart valves," the agency said. "Health care professionals should promptly transition any patient with a mechanical heart valve who is taking Pradaxa to another medication."

In addition, more bleeding after valve surgery was found in the patients taking dabigatran etexilate mesylate than in warfarin users.The drug's safety among patients with bioprosthetic valves has not been evaluated and cannot be recommended, the FDA said.

The agency advices patients with any type of prosthetic heart valve replacements, who are taking dabigatran etexilate mesylate to talk with 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, as stopping anticoagulants suddenly can increase the risk of blood clots and stroke.

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