On June 21 the U.S. Food and Drug Administration (FDA) approved Pradaxa, a blood thinner designed to treat venous thromboembolism in children between the ages of three months and 12 years old..
Dabigatran etexilate, marketed as Pradaxa, is the first FDA-approved oral anticoagulant for children.
Previously, the only blood thinner approved for pediatric patients was an injectable formulation.
JAMA network eports: The agency also approved the oral pellets to prevent recurrent blood clots in the same age group after treatment for a first venous thromboembolism is completed. Oral capsules received approval for children aged 8 years or older after at least 5 days of injected blood thinners and to prevent recurrent clots after completion of treatment for a first venous thromboembolism.
The approval was based on results from an open-label clinical trial involving 267 children who were randomized to receive oral dabigatran etexilate or usual care. According to the FDA, about 46% of the group who took the oral drug met a composite end point—not dying from a blood clot, having completely resolved blood clots, or having no additional blood clots—compared with about 42% of the patients who received standard care.
The most common adverse events in children were digestive symptoms and bleeding. The drug also includes a boxed warning cautioning that early discontinuation can increase the risk of blood clots and that blood accumulated in the spine in patients undergoing spinal procedures can cause serious adverse events.
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