A boxed warning has been added to dabigatran cautioning that discontinuation of the drug may put patients at risk of stroke.
Dabigatran (Pradaxa, Boehringer Ingelheim), an oral anticoagulant that reduces the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, previously included a similar warning in its prescribing information and medication guide. Physicians are advised to consider another anticoagulant if dabigatran is discontinued for a reason other than pathological bleeding.
In addition, the label has been updated to include thrombocytopenia as an adverse reaction in the postmarketing experience section and results from the RE-LY trial. RE-LY demonstrated that dabigatran 150 mg had a lower rate of all-cause mortality compared with warfarin (3.6 percent annually vs. 4.1 percent) as well as a lower rate of vascular death (2.3 percent annually vs. 2.7 percent). Non-vascular death rates were similar in the treatment groups.