FDA Approves Oral Blood Thinner for Children
The US Food and Drug Administration has approved dabigatran etexilate (pradaxa) oral pellets for children aged 3 months to less than 12 years with venous thromboembolism following treatment with injectable blood thinner for at least 5 days.
It has also been approved as a capsule for the treatment of blood clots in patients aged 8 years or older with venous thromboembolism directly following treatment with injectable blood thinner for at least 5 days, and for the prevention of recurrent clots in patients aged 8 years or older who were treated for their first thromboembolism.
The drug was originally approved in 2010 for the reduction of stroke and systemic embolism risk in adults with nonvalvular atrial fibrillation.
The most common adverse effects include digestive system symptoms and bleeding.
FDA approves first oral blood thinning medication for children. News release. US Food and Drug Administration; June 21, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-blood-thinning-medication-children