(RxWiki News) The US Food and Drug Administration (FDA) has approved the first oral blood-thinning medication for kids.
This medication is called Pradaxa (dabigatran etexilate). The FDA approved it to treat venous thromboembolism in children. Venous thromboembolism is a condition that causes blood clots to form in the veins.
The FDA approved Pradaxa to be used in two ways. First, it is approved as an oral pellet to be given to children between 3 months and 12 years old who have venous thromboembolism after they have been treated with a blood thinner given by injection. Second, the FDA authorized Pradaxa for the same use in capsule form in children who are at least 8 years old.
“The FDA is committed to helping our youngest patients with serious medical conditions have treatments that are relatively easy to take,” said Dr. Ann Farrell, director of the FDA's Division of Non-Malignant Hematology, in a press release. “With today’s approval of Pradaxa, pediatric patients have another therapeutic option to treat and prevent potentially deadly blood clots.”
Children who have been admitted to an intensive care unit or who have cancer, heart disease or a central venous catheter are at particularly high risk for blood clots. Venous thromboembolism in children can cause lung damage, chest pain, swelling and discomfort near the clot and death.
Pradaxa was previously approved for use in adults with atrial fibrillation. To determine whether it was safe and effective in children, the FDA looked at the results of two studies of Pradaxa in children under 18.
The first study tested whether the drug was safe and effective in treating blood clots in 267 children. Among those receiving Pradaxa, 45.8 percent saw their blood clots resolve and had no new blood clots. Among those being treated with the standard of care, that figure was 42.2 percent.
In the second study, researchers tested whether Pradaxa was safe and effective at preventing recurring blood clots in 214 children from the same population as the first study. Compared to the standard of care, Pradaxa appeared to be similarly effective at preventing recurring blood clots, the FDA reported.
Side effects of Pradaxa included bleeding and digestive problems. This medication can cause serious and potentially fatal bleeding, the FDA noted. The FDA said Pradaxa is not to be given to patients with bioprosthetic heart valves or triple-positive antiphospholipid syndrome.
Pradaxa also comes with a boxed warning — the most serious type of medication warning — noting the risk of increased blood clots if you stop Pradaxa early. This warning also notes that patients who are undergoing spinal procedures and have blood accumulation in parts of the spinal cord may experience severe side effects.
Talk to your child's doctor about the best treatment for your child's condition.
The FDA granted approval of Pradaxa to Boehringer Ingelheim Pharmaceuticals, Inc.
