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FDA Drug Safety Podcast: Pradaxa (dabigatran etexilate mesylate) should not be used in patients with mechanical prosthetic heart valves

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Narrator: Welcome to the FDA Drug Safety Podcast from the Division of Drug Information. Today’s Topic: Pradaxa (active ingredient dabigatran etexilate mesylate) should not be used in patients with mechanical prosthetic heart valves

US Public Health Service LCDR Beth Carr in the division will provide you with additional information about this communication.

LCDR Carr: On December 19, 2012, the FDA issued a Drug Safety Communication informing healthcare professionals and the public that the anticoagulant Pradaxa should not be used to prevent stroke or blood clots in patients with mechanical heart valves. The RE-ALIGN clinical trial in Europe was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in warfarin users.

Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems. FDA is requiring a contraindication of Pradaxa in patients with mechanical heart valves. Healthcare professionals should promptly transition any patient with a mechanical heart valve who is taking Pradaxa to another medication. The use of Pradaxa in patients with another type of valve replacement made of natural biological tissue, known as  bioprosthetic valves, has not been evaluated and cannot be recommended. Patients with all types of prosthetic heart valve replacements taking Pradaxa should talk to their healtcare professional as soon as possible to determine the most appropriate anticoagulation treatment.  Patients should not stop taking anticoagulant medications without guidance from their healthcare professional; stopping Pradaxa or other anticoagulants suddenly can increase the risk of blood clots and stroke.

FDA previously released a Drug Safety Communication about the risk of serious bleeding associated with the use of Pradaxa in patients with non-valvular atrial fibrillation (the population for which the drug is approved).  FDA has not changed its recommendations regarding use of Pradaxa in the population for which it is approved.

At this time FDA recommends Healthcare Professionals be aware of the following:

  • Pradaxa is approved to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Pradaxa has not been evaluated in the treatment of atrial fibrillation caused by heart valve problems and cannot be recommended in these patients.
  • Pradaxa should not be used to prevent valve thrombosis or thromboembolism (such as stroke, myocardial infarction, systemic embolism, prosthetic mechanical valve thrombosis, and vascular death) in patients with mechanical prosthetic heart valves.  The RE-ALIGN trial was terminated early because thromboembolic events and major bleeding were significantly more frequent in the Pradaxa treatment arm than in the warfarin treatment arm.
  • The use of Pradaxa has not been evaluated in patients with bioprosthetic valves and use cannot be recommended for such patients.
  • Adverse events involving Pradaxa should be reported to the FDA MedWatch program at www.fda.gov/medwatch

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to the previous communication and this communication, including the complete Data Summary, can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

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