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Labeling Updates for Anticoagulant Drug Pradaxa (Dabigatran)

Label now includes boxed warning and new phase III data (Apr. 30)

Three important updates have been made to the U.S. prescribing information for Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim), an oral anticoagulant indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF).

  • The label now carries a boxed warning, similar to the boxed warnings in the labels of other new oral anticoagulants, to advise patients that discontinuing treatment puts them at increased risk of stroke. A similar warning was previously stated in the Pradaxa prescribing information (sections 5.3 and 17.1).
  • The postmarketing experience section of the Pradaxa label has been updated to include thrombocytopenia.
  • The Pradaxa label now includes data from the pivotal RE-LY trial, which showed a lower annual rate of all-cause death with Pradaxa 150 mg than with warfarin (3.6% vs. 4.1%, respectively). The annual rate of vascular death was also lower with Pradaxa compared with warfarin (2.3% vs. 2.7%, respectively). Non-vascular death rates were similar in both treatment arms.

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

The efficacy and safety of Pradaxa were established in the phase III RE-LY trial, which involved 18,113 patients with NVAF. In this study, Pradaxa was shown to be 36% better than warfarin at reducing the risk of stroke in patients with NVAF. Pradax also achieved a 25% reduction in ischemic stroke and a 74% reduction in hemorrhagic stroke compared with warfarin.

Source: Boehringer Ingelheim; April 30, 2013.

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