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Venous thromboembolism: FDA has approved Fragmin, first anticoagulant for children at least 1 month


The FDA ( Food and Drug Administration ) has approved Fragmin ( Dalteparin sodium ) injection to reduce the recurrence of symptomatic venous thromboembolism ( VTE ) among children aged at least 1 month.

Children with venous thromboembolism, which includes deep vein thrombosis and pulmonary embolism and often develops as a secondary complication from an underlying condition such as cancer, infection, congenital heart disease, trauma, surgery or having a venous catheter, have an increased risk for in-hospital mortality, recurrent VTE and post-thrombotic syndrome.

Dalteparin sodium, a type of Heparin, was first approved in 1994 for the treatment of adults.
The pediatric approval was based, in part, on data from a trial that has included 38 children with symptomatic deep vein thrombosis or pulmonary embolism who received Dalteparin sodium for up to 3 months at doses determined by age and weight.

Twenty-one patients achieved resolution of venous thromboembolism, seven patients have experienced regression and two patients had no change.
None of the children experienced VTE progression; one patient experienced VTE recurrence.

Common adverse events associated with Dalteparin sodium include: bleeding and hemorrhage, thrombocytopenia, hematoma or pain at the injection site, and transient transaminase elevation.

Fragmin’s label includes a boxed warning to alert health care professionals and patients about the risk for epidural or spinal hematomas, which may result in long-term or permanent paralysis, among patients taking low-molecular-weight Heparin or heparinoids who receive neuraxial anesthesia or undergo spinal puncture.
Patients with indwelling epidural catheters; those taking NSAIDs, platelet inhibitors or other anticoagulants; those with a history of traumatic or repeated epidural or spinal punctures; and those with a history of spinal deformity or surgery are at increased risk for epidural or spinal hematomas with Heparin. ( Xagena )

Source: FDA, 2019

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