Boehringer Ingelheim’s Pradaxa approved by the FDA for oral pediatric use

USA – The Food and Drug Administration (FDA) has approved Boehringer Ingelheim’s Pradaxa as the first oral blood thinning medication suitable for children 12 years and below in the USA.

The medication Pradaxa will be available for use for children with venous thromboembolism immediately after treatment with a blood thinner given by injection for at least five days.

Venous thromboembolism (VTE) is a disorder that includes deep vein thrombosis and pulmonary embolism with deep vein thrombosis (DVT) occurring when a blood clot forms in a deep vein, usually in the lower leg, thigh, or pelvis whereas pulmonary embolism (PE) occurs when a clot breaks loose and travels through the bloodstream to the lungs.

Venous thromboembolism (VTE) in pediatrics is quickly becoming a well-recognized cause of significant morbidity and mortality in children.

Most children diagnosed with VTE have a serious underlying primary illness such as cancer, chronic total parenteral nutrition (TPN) dependency, or congenital heart disease.

Infants and adolescents are most at risk of developing VTE, and the most significant risk factor is the presence of a central venous line (CVL).

Currently, the mainstays of anticoagulant therapy for children are unfractionated heparin, low molecular weight heparin, and warfarin.

Unfractionated heparin (UFH) is, perhaps, the most widely utilized anticoagulant in children and approximately 15% of hospitalized children are exposed to UFH.

Enoxaparin is probably the most commonly utilized low molecular weight heparin (LMWH) compound in the US.

Warfarin is the only vitamin K antagonist (VKA) available for clinical use in the US, and is thus the most commonly utilized VKA for pediatric VTE.

For Pradaxa, its approval comes after an open-label study of a patient population was conducted on 267 pediatric patients.

In this study, patients were randomly assigned to receive either Pradaxa or standard of care, with the two groups then compared for the number of patients who met the composite endpoint.

Results showed that 45.8% of patients taking Pradaxa met the composite endpoint, compared to 42.2% of patients receiving standard of care treatment meaning they had not died from a blood clot, their blood clots had completely resolved, and they had not additional blood clots.

The FDA further added that the most common side effect of Pradaxa include digestive system related complications, bleeding and on rare occasions severe bleeding that can be fatal.