The United States Food and Drug Administration approved Pfizer’s Fragmin, a blood-thinner in order to reduce the recurrence of symptomatic venous thromboembolism. The product is indicated for children of one month and older.
VTE includes deep vein thrombosis and pulmonary embolism which leads to the death of the patient.
Venous catheter, cancer, infection, congenital heart disease, and trauma or surgery are some of the conditions which lead to VTE.
Fragmin was a heparin product approved by the US FDA in 1994.
The current approval is based on the study in 38 pediatric patients with symptomatic deep vein thrombosis and/or pulmonary embolism. At the end of the study, 21 patients achieved resolution, 7 showed regression, 2 patients had no change in the disease, no disease progression in any patients and 1 experienced recurrence.
The common side effects with the product include hemorrhage, thrombocytopenia, hematoma, or pain at the site of injection.