FDA Approves First Anticoagulant for Children with Potentially Life-Threatening Blood Clots – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889
Officials with the FDA today approved dalteparin sodium (Fragmin, Pfizer) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients age 1 month and older. It is the first anticoagulant indicated for pediatric patients approved by the agency.
VTE can include deep vein thrombosis and pulmonary embolism, 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, MD, 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, in a prepared statement.