An anticoagulant injection, Fragmin, was approved by the Food and Drug Administration last week for pediatric patients.
Fragmin is used to reduce the recurrence of symptomatic venous thromboembolism (VTE) which includes blood clots deep in the veins of the leg and clots in the lungs. VTE is often diagnosed as a secondary condition to a venous catheter, cancer, infection, congenital heart disease, trauma or surgery.
“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,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence. “Prior to this approval, there had been no FDA-approved therapies to treat VTE in pediatric patients. Given the unmet need, we granted the Fragmin application priority review and today we are approving it as the first anticoagulant (blood thinner) indicated for pediatric patients. We remain committed to advancing treatments for children with unmet medical needs.”
The common side effects of Fragmin include hemorrhage, thrombocytopenia, hematoma, pain at the injection site and elevated liver enzymes. Health care professionals should watch for bleeding in patients who take other anticoagulants.
