FDA Approves Dalteparin Sodium as First Anticoagulant For Use in Pediatric VTE Patients

The US Food and Drug Administration has approved dalteparin sodium (Fragmin; Pfizer) as the first anticoagulant indicated for use in pediatric patients older than 1 month to reduce the risk of symptomatic venous thromboembolism (VTE) related to conditions such as congenital heart disease and cancer.

The drug, which was approved for use in adults in 1994, is a low-molecular-weight heparin that is injected subcutaneously. The FDA granted it priority review in this setting.

This approval is supported by results of a 38-patient study that demonstrated efficacy: after 3 months, 21 patients showed resolution and seven saw regression of their qualifying VTE with age- and weight-guided doses of dalteparin sodium.

Because of the common side effects observed with the drug, including bleeding, thrombocytopenia, hematoma, and transient elevation of transaminases, the FDA advises caution in patients with increased risk of hemorrhage and/or those who are already on anticoagulants. They also warn not to use benzyl alcohol preservative multiple-dose formulations in infants.

Lastly, the label includes a boxed warning that epidural or spinal hematomas can occur in patients who are anticoagulated with low-molecular-weight heparins and are receiving neuraxial anesthesia or undergoing spinal puncture as these hematomas may result in long-term or permanent paralysis.