Pradaxa Becomes First FDA-Approved Oral Blood Thinner for Children

Pradaxa Becomes First FDA-Approved Oral Blood Thinner for Children

June 15, 2021 – The U.S. FDA has approved a new indication for Pradaxa^® (dabigatran etexilate), manufactured by Boehringer Ingelheim, to treat children at least three months old who have venous thromboembolism (blood clots in the veins) directly after they have received treatment with a blood thinner given by injection for at least five days, as well as to prevent recurrent clots in the same age group if the child has completed treatment for their first venous thromboembolism. Pradaxa is the first oral blood-thinning medication FDA approved for use in children.

In addition to the new indication, the FDA has approved a new oral pellet dosage form of Pradaxa. The oral pellets are indicated for use in patients three months to less than 12 years of age, while Pradaxa’s original capsule dosage form is indicated for use in patients who are at least eight years old.

Children with the greatest risk of developing blood clots are those who have cancer, congenital heart disease, or a central venous catheter, as well as those who are admitted to an intensive care unit. Venous thromboembolism may be fatal, and can cause swelling, pain, and lung damage.

In a clinical study, 45.8% of children taking Pradaxa met the composite endpoint versus 42.2% of children receiving a current standard of care. The composite endpoint required that patients had not died from a blood clot, saw their blood clots completely resolve, and had no additional blood clots.

Recommended dosing varies based on several factors, including the indication and patient’s creatinine clearance (a measure of kidney function). A black box warning cautions that there is a risk of spinal or epidural hematomas – which can lead to long-term or permanent paralysis – in patients treated with Pradaxa who receive neuraxial anesthesia or undergo spinal puncture. There is also a black box warning that premature discontinuation of oral anticoagulants, including Pradaxa, increases the risk of thrombotic events.

Pradaxa first received FDA approval in 2010 and is also indicated to treat and prevent conditions such as deep vein thrombosis, pulmonary embolism, stroke, and systemic embolism in adults.