Boehringer Ingelheim announced three major updates to the prescribing information for Pradaxa (dabigatran etexilate mesylate) capsules, an oral anticoagulant indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

Changes to the labeling include:

  • A Boxed Warning to advise patients that discontinuing treatment puts them at increased risk of stroke.  
  • The incidence of thrombocytopenia in the post marketing experience section
  • Data from the RE-LY trial that showed a lower rate of all-cause death with Pradaxa 150mg than warfarin (3.6% per year vs. 4.1% per year). Also, the rate of vascular death was lower on Pradaxa compared to warfarin (2.3% per year vs. 2.7% per year). Non-vascular death rates were similar in the treatment arms.

The updated label does not change the positive benefit-risk profile of Pradaxa 150mg twice daily when used as directed.

Pradaxa is available in 75mg and 150mg strength capsules.

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