The Food and Drug Administration (FDA) has approved Boehringer Ingelheim’s Pradaxa as the first oral blood thinning medication to treat children aged three months to less than 12 years old in the US.
The FDA has cleared Pradaxa (dabigatran etexilate) for use in children with venous thromboembolism, immediately after treatment with a blood thinner given by injection for at least five days.
Pradaxa oral pellets have also been approved to prevent recurrent clots among children aged three months to less than 12 years old, who have complete treatment for their first venous thromboembolism.
Lastly, the drug has been approved in capsule form to treat blood clots in patients eight years and older with venous thromboembolism, directly after they have been treated with a blood thinner given for at least five days, and to prevent clots in patients aged eight years and older who have completed treatment for their first venous thromboembolism.
The approval of Pradaxa in this patient population is supported by data from an open-label study including 267 paediatric patients.
In this study, patients were randomly assigned to receive either Pradaxa or standard of care, with the two groups then compared for the number of patients who met the composite endpoint.
Results showed that 45.8% of patients taking Pradaxa met the composite endpoint, compared to 42.2% of patients receiving standard of care treatment – meaning they had not died from a blood clot, their blood clots had completely resolved, and they had not additional blood clots.
The most common side effects of Pradaxa include digestive system problems and bleeding, with the FDA adding in a statement that the drug can cause ‘serious and fatal bleeding’.