OTTAWA, Dec. 21, 2012 /CNW/ -
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
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
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.
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
Pradaxa will be contraindicated for use in patients with artificial
heart valves requiring anticoagulant treatment due to their valvular
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
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:
Stay connected with Health Canada and receive the latest advisories and
product recalls using social media tools.
Également disponible en français
SOURCE: Health Canada
For further information: