The Food and Drug Administration (FDA) has approved Boehringer Ingelheim’s Pradaxa as the first oral blood thinning medication to treat children aged three months to less than 12 years old in the US. The FDA has cleared Pradaxa (dabigatran etexilate) for use in children with venous thromboembolism, immediately after treatment with a blood thinner given by injection for at least five days. Pradaxa oral pellets have also been approved to prevent recurrent clots among children aged three months to less than 12 years old, who have complete treatment for their first venous thromboembolism. Lastly, the drug has been approved in capsule form to treat blood clots in patients eight years and older with venous thromboembolism, directly after they have been treated with a blood thinner given for at least five days, and to prevent clots in patients aged eight years and older who have completed treatment for their first venous ...
Real-world outcomes among patients with atrial fibrillation taking the anticoagulant dabigatran (Pradaxa) mimic those reported in clinical trials, with dabigatran use associated with lower rates of brain bleeds, and similar rates of stroke and extracranial hemorrhage as treatment with warfarin in a new study.
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