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.
As per the Canadian Product Monograph, Pradaxa (dabigatran etexilate) is approved for the prevention of blood clots in patients who have undergone hip replacement or total knee replacement surgery, and for the prevention of strokes and blood clots in the body in patients with atrial fibrillation (irregular heart beat) in whom a medication to prevent blood clotting is considered appropriate.
▲A recent European clinical trial involving patients with a type of artificial heart valve was terminated early due to significantly more adverse events for patients using Pradaxa. See Hazards tab for more information.
What patients should 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.
What health care professionals should do:
•Pradaxa is contraindicated now in patients with artificial heart valves requiring anticoagulant treatment due to their valvular status.
•Consider promptly transitioning any patient with an artificial heart valve who is taking Pradaxa to another appropriate anticoagulant medication.
•Report adverse reactions to Health Canada.
•Please note that the information in the associated Notice to Hospitals supplements the information on this issue (dated December 21, 2012) provided by Boehringer Ingelheim (Canada) Ltd., the manufacturer of Pradaxa.