FDA has approved a Pfizer sNDA for Fragmin (dalteparin sodium) subcutaneous injection to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients aged one month and older. VTE includes deep vein thrombosis and pulmonary embolisms, an agency release says. “Most children who have VTE are fighting a serious underlying primary illness such as cancer or congenital heart disease,” it says.
Fragmin was initially approved in 1994 for adults and is a type of heparin. Pediatric use approval was based on data from a single trial with 38 pediatric patients with symptomatic deep vein thrombosis or a pulmonary embolism. Patients were treated with Fragmin for up to three months, with starting doses by age and weight. “At study completion, 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,” the agency says.
The approval also requires a Boxed Warning to alert health care professionals and patients that epidural or spinal hematomas may occur in patients who are anticoagulated due to taking certain medications called low molecular weight heparins or heparinoids and are receiving neuraxial anesthesia (injection near the spine) or undergoing spinal puncture (removing spinal fluid for testing). The hematomas may result in long-term or permanent paralysis, FDA says.