OTTAWA, Dec. 21, 2012 /CNW/ -

The 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.

Who is affected:

Patients who are taking Pradaxa and have an artificial heart valve.

What Health Canada is doing:

Health Canada is working with the manufacturer of Pradaxa, Boehringer Ingelheim (Canada) Ltd., to update the Canadian Product Monograph for Pradaxa to strengthen the present warning that the drug should not be prescribed to patients with artificial heart valves. The Product Monograph for Pradaxa currently recommends against the use of Pradaxa in patients with artificial heart valves.

Background:

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 stroke 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.

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/R E P E A T -- Advisory - Pradaxa (dabigatran, previously called Pradax): not to be used in patients with artificial ...