Public recall detail

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

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Recall Safety notice
Quick summary

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

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

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

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

Brand

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

  • 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.
Additional official information
Background{"text":"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."}
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Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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