Pediatrics

FDA Approves First Anticoagulant for Pediatric Patients

Amanda Balbi

The US Food and Drug Administration has approved the first anticoagulant for pediatric patients aged one month or older. Dalteparin sodium (Fragmin) injection reduces the recurrence of symptomatic venous thromboembolism (VTE).

This approval comes after a single trial of 38 pediatric patients with symptomatic deep vein thrombosis and/or pulmonary embolism showed that Fragmin was safe and effective in this population. After 3 months, the treatment resolved VTE in 21 of the 38 patients and regressed VTE in 7 of the patients.

Common side effects reported were hemorrhage, thrombocytopenia, hematoma or pain at the injection site, and transient elevation of transaminases.

“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,” 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.

—Amanda Balbi

Reference:

FDA approves first anticoagulant (blood thinner) for pediatric patients to treat potentially life-threatening blood clots [press release]. Silver Spring, MD: US Food and Drug Administration; May 16, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-first-anticoagulant-blood-thinner-pediatric-patients-treat-potentially-life-threatening?utm_campaign=05162019_PR_FDA%20approves%20blood%20thinner%20for%20pediatric%20patients&utm_medium=email&utm_source=Eloqua.