Dalteparin for paediatric VTEJuly 5, 2019
The US FDA approved dalteparin sodium (Fragmin) injection, for subcutaneous use, to reduce the recurrence of venous thromboembolism (VTE) in paediatric patients one month of age and older.
VTE can include deep vein thrombosis and pulmonary embolism, which can lead to death.
Dalteparin was initially approved by the FDA in 1994 for adults. It is a type of heparin which works as an anticoagulant.
The efficacy of the drug in children was based on a single trial with 38 paediatric patients with symptomatic deep vein thrombosis and/or pulmonary embolism.
Patients were treated with dalteparin 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.