FDA approves first anticoagulant (blood thinner) for pediatric patients to treat potentially life-threatening blood clots
The U.S. Food and Drug Administration today approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older. VTE can include deep vein thrombosis (blood clot in the deep veins of the leg) and pulmonary embolism (blood clot in the lungs), which can lead to death. "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, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "Prior to this approval, there had been no FDA-approved therapies to treat VTE in pediatric patients. Given the unmet need, ...