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.
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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.
Niamh Harris