The USFDA has approved dabigatran etexilate, the first oral blood-thinning drug to treat venous thromboembolism in the pediatric population. The drug is advisable for treating children aged 3 months to 12 years directly after being administered an intravenous blood thinner for at least five days. Pellets are also approved to prevent recurrent clots in patients who have completed the treatment for their first venous thromboembolism. Dabigatran etexilate was originally approved to reduce stroke and systemic embolism in adults with non-valvular atrial fibrillation.
The safety and efficacy of the drug were evaluated by two studies in patients aged less than 18 years. Study 1: 1 A total of 267 pediatric patients (divided into two groups) were treated with either dabigatran etexilate or standard care. Endpoint analysis included no deaths due to clots, reduced blood clots, and no additional…
