The U.S. Food and Drug Administration (FDA) approved Pradaxa (dabigatran etexilate) oral pellets to treat children between the ages of 3 months and up to 12 years old with venous thromboembolism (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.
In addition, the FDA approved Pradaxa in capsule form to treat blood clots in patients who are at least 8 years old 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.
The agency also said 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. Pradaxa was originally approved in 2010 to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.
The safety and efficacy of Pradaxa for treating blood clots in patients younger than 18 years old was evaluated in one study of 267 pediatric patients. In this open-label study, patients were randomly assigned to receive either Pradaxa or standard of care. The study compared the two groups for the number of patients who met the composite endpoint (a combination of multiple clinical endpoints), which meant that they had not died from a blood clot, their blood clots had completely resolved, and they had no additional blood clots. Results showed that 81 (45.8%) of the 177 people taking Pradaxa met the composite endpoint compared to compared to 38 (42.2%) of the 90 patients who received standard of care.
