Pediatric patients one month and older can now be treated for blood clots in the leg and lungs.
Fragmin (dalteparin sodium) from Pfizer is a type of heparin that works as an anticoagulant. It was first approved by the U.S. Food and Drug Administration (FDA) for use in adults in 1994.
The company recently conducted a clinical trial for Fragmin involving 38 pediatric patients with venous thromboembolism (VTE), which can include symptomatic deep vein thrombosis (blood clot in the deep veins of the leg) and/or pulmonary embolism (blood clot in the lungs). The children were treated for up to three months. Slightly more than half experienced resolution of their VTEs and nearly one-fifth showed regression.
Based on these results, the FDA approved Fragmin for subcutaneous use to reduce the recurrence of symptomatic VTE in pediatric patients one month of age and older. It is the first drug approved by the agency for the treatment of VTE in pediatric patients and was approved under priority review.
The challenge with treating VTE in pediatric patients is the fact that VTEs generally occur in these patients as a secondary complication of an underlying serious clinical condition. Most children with VTEs are fighting cancer, serious infections or congenital heart disease or have been subjected to some type of trauma or surgery.
Fragmin comes with a boxed warning regarding the potential for the occurrence of epidural or spinal hematomas (accumulation of blood that can mechanically compress the spinal cord) in patients treated with low molecular weight heparins (LMWH) or heparinoids and who are receiving neuraxial anesthesia (injection near the spine) or undergoing spinal puncture (removing spinal fluid for testing).
