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FDA Drug Safety Podcast for Healthcare Professionals: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate)

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Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today’s topic: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate).

Lena Choe, a pharmacist in the Division, will provide you with additional information about this Communication.

Guest Speaker: On December 7, 2011 the Food and Drug Administration is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa. Pradaxa is an anticoagulant medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation, the most common type of heart rhythm abnormality. 

At this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label.  

Patients with atrial fibrillation should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke. Strokes can lead to permanent disability and death. 

Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. The Pradaxa drug label contains a warning about significant and sometimes fatal bleeds. In a large clinical trial of 18,000 patients comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs.   

FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa.  FDA is working closely with the manufacturer of Pradaxa, Boehringer Ingelheim, to evaluate the post-market reports of bleeding. 

FDA will communicate any new information on the risk of bleeding and Pradaxa when it becomes available. 

At this time, FDA recommends that Healthcare Professionals be aware that: 

  1. If Pradaxa is prescribed, carefully follow the approved indication and other recommendations, such as dosage and administration, in the professional drug label.
  2. Patients should know the signs and symptoms of bleeding and when to seek care.
  3. Pradaxa is eliminated by the kidneys; therefore, renal function should be assessed prior to treatment with Pradaxa to determine the appropriate dose. Also, renal function should be reassessed during treatment with Pradaxa if clinically indicated by fluctuating renal function, diuretic use, or hypovolemia and the dose should be adjusted following recommendations in the label.
  4. There is no need for dosage adjustment in patients with mild to moderate renal impairment with a creatinine clearance > 30 mL/min. These patients should be given a dose of Pradaxa 150 mg orally twice daily.
  5. For patients with severe renal impairment, follow the recommended doses: Patients with a creatinine clearance 15-30 mL/min, the recommended dose is 75 mg orally twice daily. For patients with a creatinine clearance <15 mL/min or on dialysis information cannot be provided.
  6. Report adverse events involving Pradaxa 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 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

Follow us on Twitter @FDA_Drug_Info for up to the minute important drug information. Know the moment it happens.  


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