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News From the Food and Drug Administration
August 17, 2021

First Oral Blood Thinner Is Approved for Children

JAMA. 2021;326(7):593. doi:10.1001/jama.2021.13259

The FDA approved dabigatran etexilate as the first oral blood thinner for children aged 3 months to 11 years who have venous thromboembolism and received injectable blood thinners for at least 5 days. Previously, the only anticoagulant approved for children was an injectable formulation.

“The FDA is committed to helping our youngest patients with serious medical conditions have treatments that are relatively easy to take,” Ann Farrell, MD, director of the FDA’s Division of Non-Malignant Hematology, said in a statement.

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