The U.S. Food and Drug Administration approved Boehringer Ingelheim Pharmaceuticals, Inc.’s Pradaxa (dabigatran etexilate) oral blood thinning medication for children.
Pradaxa is the first FDA-approved blood thinning medication that children can take by mouth. The only other approved blood thinning medication for children is given by injection.
The approval for the oral pellets is given to treat children 3 months to less than 12 years old with venous thromboembolism, which is a condition where blood clots form in the veins, directly after they have been treated with a blood thinner given by injection for at least five days.
The FDA also approved Pradaxa oral pellets to prevent recurrent clots among patients 3 months to less than 12 years old who completed treatment for their first venous thromboembolism.
The drug was also 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 by injection for at least five days, and to prevent recurrent clots in patients eight years and older who completed treatment for their first venous thromboembolism.
Venous thromboembolism can lead to complications, including swelling and discomfort near the clot, chest pain, lung damage, and even death.
Pradaxa was originally approved in 2010 to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.
The FDA granted the approval for Pradaxa after evaluating its safety and efficacy for treating blood clots in patients younger than 18 in one study of 267 pediatric patients. In the open-label study, patients were randomly assigned to receive either Pradaxa or standard of care.
Further, the safety of Pradaxa to prevent recurrent blood clots in the same pediatric population was evaluated in an open-label, single-arm study in 214 patients with a history of blood clots.
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