FDA OKs Dalteparin Sodium for Children with Potentially Life-Threatening Blood Clots

Dalteparin sodium is the first anticoagulant indicated for pediatric patients approved by the agency.

Officials with the FDA today approved dalteparin sodium (Fragmin, Pfizer) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients age 1 month and older. It is the first anticoagulant indicated for pediatric patients approved by the agency.

VTE can include deep vein thrombosis and pulmonary embolism, which can lead to death.

“Most children who have VTE are fighting a serious underlying primary illness such as cancer or congenital heart disease. Not only are they fighting a serious illness, having a condition like VTE can then lead to significant complications and even death,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a prepared statement.

Pfizer’s application for dalteparin sodium was given Priority Review status, according to the FDA, due to a need that was unmet, according to the agency.

“Prior to this approval, there had been no FDA-approved therapies to treat VTE in pediatric patients,” said Pazdur. “We remain committed to advancing treatments for children with unmet medical needs.”

VTE usually develops as a secondary complication of underlying clinical conditions such as a venous catheter, cancer, infection, congenital heart disease, and trauma or surgery. Pediatric VTE is associated with an increased risk of in-hospital mortality, recurrent VTE and post-thrombotic syndrome.

Dalteparin sodium was first approved by the FDA in 1994. The efficacy of dalteparin sodium in children was based on a single trial with 38 pediatric patients with symptomatic deep vein thrombosis and/or pulmonary embolism. Patients were treated with dalteparin sodium for up to 3 months, with starting doses by age and weight.

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