Effective for dabigatran reversal among patients with uncontrolled bleeding, undergoing urgent surgery
Study patients were randomized to Pradaxa 150mg twice daily or warfarin (target INR 2-3) and remained on this treatment for the trial duration.
The researchers found that the risk of developing an intraocular hemorrhage was reduced with dabigatran or rivaroxaban at 365 days (hazard ratio, 0.75; 95% confidence interval, 0.58 to 0.97; P=0.03) but not at 90 days (hazard ratio, 0.73; 95% confidence interval, 0.22 to 2.63; P=0.13).
Boehringer Ingelheim announced that the prescribing information for Pradaxa (dabigatran etexilate mesylate) capsules was updated to include a contraindication related to use in patients with mechanical prosthetic heart valve replacement.
Interim results of a retrospective analysis comparing major bleeding events in patients treated with Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim) and warfarin were announced at the American Heart Association's Scientific Session 2014.
Drugs in the Pipeline
The Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for idarucizumab (Boehringer Ingelheim) to reverse the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate) in patients needing emergency intervention or experiencing an uncontrolled or life-threatening bleeding event.
For patients with atrial fibrillation hospitalized with stroke or transient ischemic attack, use of novel oral anticoagulants (NOACs) has increased over time.
Pradaxa (dabigatran etexilate capsules) 150mg, an oral direct thrombin inhibitor, will be made available by Boehringer Ingelheim on November 3, 2010.
Compared with warfarin, apixaban was correlated with reduced risk of major bleeding and intracranial bleeding (adjusted hazard ratios, 0.66 and 0.4, respectively) and dabigatran was correlated with reduced risk of intracranial bleeding (adjusted hazard ratio, 0.45) among patients with atrial fibrillation.
The FDA is alerting healthcare providers and patients of important storage and handling requirements for Pradaxa (dabigatran etexilate mesylate capsules; Boehringer Ingelheim).