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U.S. Department of Health and Human Services

Safety

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Pradaxa (Dabigatran Etexilate)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2012

Summary View

 

CONTRAINDICATIONS

  • Mechanical prosthetic heart valve
 

WARNINGS AND PRECAUTIONS

Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves
  • The safety and efficacy of Pradaxa in patients with bileaflet mechanical prosthetic heart valves was evaluated in the RE-ALIGN trial, in which patients with bileaflet mechanical prosthetic heart valves (recently implanted or implanted more than three months prior to enrollment) were randomized to dose adjusted warfarin or 150, 220, or 300 mg of Pradaxa twice a day…
 

MEDICATION GUIDE

Do not take Pradaxa if you:
  • Have ever had or plan to have a valve in your heart replaced