FDA approves oral blood thinner for children

The US Food and Drug Administration (FDA) approved Pradaxa (dabigatran etexilate) to treat venous thromboembolism in children aged 3 months to less than 12 years.

The US Food and Drug Administration has approved Pradaxa (dabigatran etexilate) from Boehringer Ingelheim Pharmaceuticals, Inc., for the treatment of venous thromboembolism in children aged 3 months to less than 12 years following treatment for at least 5 days with a blood thinner that has been administered by injection.1 The approval also included the use of dabigatran etexilate for the prevention of recurrent clots in children who have completed treatment for venous thromboembolism.

The efficacy of dabigatran etexilate was evaluated in a study of 267 participants. The participants were randomized to either receive standard of care or dabigatran etexilate and compared both groups to see how many patients met the composite endpoint: no deaths from blood clots, complete resolution of blood clots, and no additional blood clots. Eighty-one of 177 participants in the intervention group met the composite endpoint and 38 of 90 participants achieved it in the standard of care group. Safety was evaluated in a single-arm study of 214 patients. The most common side effects included digestive system symptoms and bleeding. Dabigatran etexilate comes with a boxed warning that cautions that discontinuing treatment early could increase the risk of blood clots. It’s not recommended for patients who have bioprosthetic heart valves or triple-positive antiphospholipid syndrome.

Reference

1. US Food and Drug Administration. FDA Approves First Oral Blood Thinning Medication for Children. Published June 21, 2021. Accessed June 22, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-blood-thinning-medication-children