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

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 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.

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.

Additional information for health care practitioners:

• An interim analysis of the study results showed a statistically significant excess of thrombosis events in the Pradaxa treatment arm compared to the warfarin treatment arm, including valve thrombosis, stroke and myocardial infarction in patients with recent  mechanical heart valve placement receiving dabigatran (p=0.033 Fishers's Exact Probability).
• Pradaxa will be contraindicated for use in patients with artificial heart valves requiring anticoagulant treatment due to their valvular status.
• Health care professionals should promptly transition any patient with an artificial heart valve who is taking Pradaxa to another anticoagulant medication, such as warfarin.
• Health care professionals are reminded to strictly follow the recommended conditions of use for Pradaxa outlined in the Canadian Product Monograph.

For more information:

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report side effects to health products to Health Canada:

• Call toll-free at 1-866-234-2345
• Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Related Health Canada Web content:

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SOURCE: Health Canada

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