Avoiding the Risk of Bleeding from Pradaxa: FDA Provides Additional Information for Healthcare Professionals

By Thomas Greer | January 26, 2015

The Food and Drug Administration (FDA) announced on December 7, 2011, that it would be conducting a safety review of the drug Pradaxa, which is used to treat a common type of heart rhythm abnormality. The study focuses around the possible increased risk of bleeding for Pradaxa patients. For a demonstration of how Pradaxa can lead to increased bleeding, watch this free pradaxa informational video.

The FDA also made several recommendations to healthcare professionals, including the following:

  • If you prescribe Pradaxa, carefully follow the approved indication and other recommendations, such as dosage and administration, in the professional drug label.
  • Make sure your patients know the signs and symptoms of bleeding and when to seek care.
  • Pradaxa is eliminated by the kidneys, therefore:
    • Renal function should be assessed prior to treatment with Pradaxa to determine the appropriate dose.
    • Renal function should be reassessed during treatment with Pradaxa if clinically indicated (fluctuating renal function, diuretic use, hypovolemia), and the dose should be adjusted following recommendations in the label.
  • There is no need for dosage adjustment in patients with mild to moderate renal impairment (creatinine clearance [CrCl] > 30 mL/min). These patients should be given a dose of Pradaxa 150 mg orally twice daily.
  • For patients with severe renal impairment, follow the recommended doses:
    • For patients with CrCl 15-30 mL/min, the recommended dose is 75 mg orally twice daily.
    • Dosing recommendations for patients with a CrCl

Understand Your Legal Rights

If you or someone you know experienced a bleeding event while taking the drug Pradaxa, call and speak to one of our defective drug attorneys today.  We are handling Pradaxa cases accross the country. Contact us for a free consultation today at 901-680-9777.

Posted in Drugs and Medical Devices, Library