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

Starting date:

December 21, 2012

Posting date:

December 21, 2012

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public (GP)

Identification number:

RA-16387

• Issue
• What you should do
• Who is affected
• What industry professionals should do
• Background
• Report health or safety concerns
• Media enquiries
• Public enquiries
• What Health Canada is doing

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 you 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.

Who is affected

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

What industry 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.

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.

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 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.

Report health or safety concerns

• 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.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709

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.