FDA Approves Fragmin as First Pediatric Anticoagulant Treatment

May 16, 2019

Fragmin, a low-molecular-weight heparin dalteparin sodium injection, was approved for symptomatic venous thromboembolism.

The FDA has approved dalteparin sodium injections (Fragmin, Pfizer) for the reduction of symptomatic venous thromboembolism (VTE) in pediatric patients one month and older. The announcement marks the first anticoagulant treatment approved for pediatric patients. Dalteparin was approved in 1994 for adults.

VTE, which usually develops as a secondary complication of underlying clinical conditions in adults, is associated with an increased risk of in-hospital mortality, recurrent VTE, and post-thrombotic syndrome in children, the FDA says in a statement.

“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. “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 indicated for pediatric patients.”

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The efficacy of Fragmin in children was based on a single trial that included 38 patients, the FDA says. The patients were treated with Fragmin for up to three months. By the study’s competition, 21 patients achieved resolution of VTE, seven showed signs of regression, two did not exhibit any substantial changes. None of the patients experienced a progression of VTE, but one patient did experience a recurrence. 

Dalteparin sodium injection is contraindicated in patients who experience active major bleeding, have a history of heparin-induced thrombocytopenia or heparin-induced thrombocytopenia or heparin induced thrombocytopenia with thrombosis, a hypersensitivity to dalteparin sodium, are undergoing epidural/neuraxial anesthesia, or have a hypersensitivity to heparin or pork products. 

Fragmin comes with a boxed warning detailing an increased risk of epidural or spinal hematomas in patients using indwelling epidural catheters, concomitant use of other drugs affecting hemostasis, patients who have a history of traumatic or repeated epidural or spinal punctures, and those with a history of spinal deformity or spinal surgery. 

Although the precise number of DVT/PE is unknown, the CDC estimates that as many as 900,000 people develop the complication each year. Half of individuals who develop a VTE will have long-term complications like swelling, pain, discoloration, and scaling in the affected limb, while 33% will have a recurrence within 10 years, the CDC says.