Medication Monitor

Generic Name (Trade Name—Company)
June 12, 2019

Dalteparin sodium injection

FDA approves first anticoagulant to treat potentially life-threatening blood clots in pediatric patients

FDA approved dalteparin sodium injection for S.C. use to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients aged 1 month and older. VTE can include deep-vein thrombosis and pulmonary embolism, which can lead to death.

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 postthrombotic syndrome.

The product was initially FDA approved in 1994 for adults and is a type of heparin, which works as an anticoagulant.

Its efficacy 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 the agent for up to 3 months, with starting doses by age and weight.

At study completion, 21 patients achieved resolution of the qualifying VTE, 7 patients showed regression, 2 patients showed no change, 0 patients experienced progression of the VTE, and 1 patient experienced recurrence of VTE.

Common adverse effects are bleeding, including hemorrhage, thrombocytopenia, hematoma, or pain at the injection site and transient elevated liver enzymes.

Health professionals should use caution in conditions with increased risk of hemorrhage and closely monitor thrombocytopenia of any degree. They should not use benzyl alcohol preservative multiple-dose formulations in infants, as they contain benzyl alcohol.

The label contains a boxed warning to alert health professionals and patients that epidural or spinal hematomas may occur in patients who are anticoagulated because they take low molecular weight heparins or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis.

Health professionals should monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.