Boehringer Ingelheim Pharmaceuticals Inc. April 30 announced that a boxed warning has been added to the label of the anticoagulant Pradaxa (dabigatran etexilate mesylate) regarding the increased risk of stroke on discontinuing treatment.
Pradaxa is an oral anticoagulant (OAC) indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
The Pradaxa label now carries a boxed warning, similar to the boxed warnings in the labels of other new OACs, to advise patients that discontinuing treatment puts them at increased risk of stroke, the company said. A similar warning was stated in the Pradaxa prescribing ...
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