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Health Canada Health products

Pradaxa (dabigatran, previously called Pradax): not to be used in patients with artificial heart valves

Issued December 21, 2012
Issue
Health Canada is advising health care professionals and the public that, based on new information, the blood-thinning drug Pradaxa is not to be used in patients with artificial heart valves (also known as prosthetic heart valves) due to the risk of strokes, bleeding, heart attacks, and blood clots forming on the artificial heart valves.
What to do
If you are taking Pradaxa and have had an artificial heart valve replacement, talk to your health care professional as soon as possible to determine the most appropriate alternative treatment. Do not stop using Pradaxa or other anticoagulants without guidance from your health care professional. Stopping anticoagulants suddenly may increase your risk of blood clots or a stroke. Report any adverse reactions (side-effects) you may have experienced to your health care professional.