The longstanding medicine for adults is now approved to treat children 3 months to less than 12 years old with venous thromboembolism.
The FDA has cleared the first oral blood thinner for children: Boehringer Ingelheim’s Pradaxa (dabigatran etexilate).
The longstanding medicine for adults is now approved to treat children three months to less than 12 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 among patients three months to less than 12 years old who completed treatment for their first venous thromboembolism.
In addition, Pradaxa was 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.
The only other approved blood thinning medication for children is given by injection, FDA said in a press release. 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 is committed to helping our youngest patients with serious medical conditions have treatments that are relatively easy to take,” said Ann Farrell, MD, director of the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research. “With today’s approval of Pradaxa, pediatric patients have another therapeutic option to treat and prevent potentially deadly blood clots.”
The safety and efficacy of Pradaxa for treating blood clots in patients younger than 18 was evaluated in one study of 267 pediatric patients. Nearly 46% of the 177 people taking Pradaxa met the composite endpoint — they had not died from a blood clot, their blood clots had completely resolved, and they had no additional blood clots — compared to 42.2% of the 90 patients who received standard of care.
Pradaxa has a boxed warning cautioning that early treatment discontinuation may increase the risk of blood clots and that blood accumulation within parts of the spinal cord (spinal or epidural hematomas) in patients undergoing spinal procedures may cause serious side effects.