FDA approves first anticoagulant (blood thinner) for paediatric patients to treat potentially life-threatening blood clots

FDA

16 May 2019 - The U.S. FDA today approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism in paediatric patients one month of age and older. 

Venous thromboembolism (VTE) can include deep vein thrombosis (blood clot in the deep veins of the leg) and pulmonary embolism (blood clot in the lungs), which can lead to death.

Fragmin was initially approved by the FDA in 1994 for adults and is a type of heparin, which works as an anticoagulant. The efficacy of Fragmin in children was based on a single trial with 38 paediatric patientswith symptomatic deep vein thrombosis and/or pulmonary embolism. Patients were treated with Fragmin for up to three months, with starting doses by age and weight. At study completion, 21 patients achieved resolution of the qualifying VTE, seven patients showed regression, two patients showed no change, no patients experienced progression of the VTE and one patient experienced recurrence of VTE.

Read FDA press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Paediatrics