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Pradaxa prescribing information updated
The labeling for dabigatran, an oral anticoagulant indicated to reduce the risk for stroke and systemic embolism in patients with nonvalvular atrial fibrillation, now carries a boxed warning that advises against discontinuing treatment due to an increased risk for stroke, according to a press release from the manufacturer.
Other updates to the prescribing information for dabigatran (Boehringer Ingelheim) include a post-marketing experience section that addresses thrombocytopenia and data from the RE-LY trial, which showed a lower rate of all-cause death with dabigatran 150 mg compared with warfarin (3.6% vs. 4.1% per year). Results also revealed a lower rate of vascular death with dabigatran vs. warfarin (2.3% vs. 2.7% per year) and similar rates of non-vascular death in both treatment arms.