FDA Approves Fragmin®, First Anticoagulant for Pediatric VTE

The U.S. Food and Drug Administration (FDA) approved Fragmin® (dalteparin) injection to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients aged one month and older. It is the first FDA-approved therapy to treat VTE in pediatric patients.

The approval was based on results of a single trial that included 38 pediatric patients with symptomatic deep vein thrombosis and/or pulmonary embolism. Patients were treated with dalteparin for up to three months, with starting doses determined based on age and weight. At the end of the study, 21 patients achieved resolution of the qualifying VTE, seven patients showed regression, and two patients showed no change. No patients experienced progression of VTE, while one patient experienced VTE recurrence.

The most common adverse events associated with dalteparin are bleeding, including hemorrhage, thrombocytopenia, hematoma; pain at the injection site; and transient elevation of transaminases.

Take caution when prescribing Fragmin®

Healthcare professionals should not use benzyl alcohol preservative multiple-dose formulations in infants. Patients should undergo periodical blood count laboratory tests. Healthcare professionals should monitor patients closely for bleeding when administering dalteparin to those who currently take anticoagulants.

Fragmin® carries a boxed warning to alert healthcare professionals and patients that epidural or spinal hematomas may occur in patients who are anticoagulated due to taking low-molecular-weight heparins (LMWHs) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include use of indwelling epidural catheters; use of other drugs that affect hemostasis at the same time when using dalteparin, such as nonsteroidal anti-inflammatory drugs, platelet inhibitors, and other anticoagulants; history of traumatic or repeated epidural or spinal punctures; and a history of spinal deformity or surgery.

Dalteparin sodium, an LMWH, has been approved by the FDA since 1994 for the treatment of adults.