FDA OKs Dalteparin (Fragmin), First Anticoagulant for Pediatric VTE

Megan Brooks

May 16, 2019

The US Food and Drug Administration (FDA) has approved dalteparin sodium (Fragmin, Pfizer) injection to reduce the recurrence of symptomatic venous thromboembolism (VTE) in children as young as 1 month.

It is the first FDA-approved therapy to treat VTE in pediatric patients.

"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," 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, said in a news release.

Given the "unmet need" for therapies to treat VTE in pediatric patients, the FDA granted the application for dalteparin priority review, Pazdur said.

Dalteparin sodium, a low-molecular-weight heparin, was first approved by the FDA in 1994 for use in adults. Its efficacy in children was based on a single trial of 38 pediatric patients with symptomatic deep vein thrombosis (DVT) and/or pulmonary embolism (PE). They received dalteparin sodium for up to 3 months, with starting doses determined by age and weight.

At the end of the study, 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, according to the FDA.

Common adverse effects with dalteparin sodium are bleeding — including hemorrhage, thrombocytopenia, hematoma — pain at the injection site, and transient elevation of liver enzymes.

Healthcare providers should monitor patients closely for bleeding when administering dalteparin to patients who currently take anticoagulants, the agency notes.

The label for dalteparin sodium contains a boxed warning stating that epidural or spinal hematomas can occur in patients taking low-molecular-weight heparins or heparinoids and who are receiving neuraxial anesthesia or undergoing spinal puncture.

Complete prescribing information is available online.

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