Silver Spring, MD—Children with cancer, congenital heart disease, a central venous catheter or those who spend time in intensive care units can be at risk for blood clots.

Even though venous thromboembolism can lead to complications, including swelling and discomfort near the clot, chest pain, lung damage, and possibly death, no oral anticoagulants were approved for children until now.

In a priority review in late June, the FDA approved dabigatran etexilate, marketed as Pradaxa, oral pellets to treat children aged 3 months to less than 12 years with venous thromboembolism. The medication is for use after patients have been treated with a blood thinner given by injection for at least 5 days. Pradaxa oral pellets also were approved to prevent recurrent clots among patients aged 3 months to less than 12 years old who had finished treatment for their first venous thromboembolism.

In addition, a capsule form of Pradaxa was given the okay to treat blood clots in patients aged 8 years and older with venous thromboembolism in both above situations.

The blood-thinning medication from Boehringer Ingelheim Pharmaceuticals, Inc. is the first oral agent approved by the FDA; previously only injectable products were available. Pradaxa was originally approved in 2010 to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular 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 and preventing recurrence in patients younger than age 18 years were evaluated in a series of open-label clinical trials. Digestive system symptoms and bleeding were found to be the most common side effects of Pradaxa.

Regulators caution, however, that, like other blood thinners, Pradaxa can cause serious and fatal bleeding and is not recommended for patients with bioprosthetic heart valves or triple-positive antiphospholipid syndrome.

The drug has a boxed warning stating that early treatment discontinuation can 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.

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