The US Food and Drug Administration (FDA) has approved dabigatran etexilate (Pradaxa) oral pellets for the treatment of venous thromboembolism (VTE) in children aged 3 months to less than 12 years. The drug is to be administered immediately after patients have completed a 5-day course of an anticoagulant given by injection.
The most common side effects include digestive system symptoms and bleeding. Dabigatran etexilate can cause serious and fatal bleeding and is not recommended for patients with bioprosthetic heart valves or triple-positive antiphospholipid syndrome.
A boxed warning cautions that stopping treatment early may increase the risk for clots and that spinal or epidural hematomas in patients undergoing spinal procedures may cause serious side effects.
Dabigatran etexilate was originally approved in 2010 for adults with nonvalvular atrial fibrillation to reduce risk for stroke and systemic embolism.
Source: FDA