The Food and Drug Administration approved the “first oral blood thinning medication for children” a few months ahead of their COVID-19 vaccine rollout for children ages 5-11.
In late June 2021, the Food and Drug Administration (FDA) approved a drug called Pradaxa; oral pellets to treat children 3 months to less than 12 years of age with venous thromboembolism, a condition that involves blood clots forming in the veins. Pradaxa is the “first FDA-approved blood thinning medication that children can take by mouth,” reads the FDA News Release.
“With today’s approval of Pradaxa, pediatric patients have another therapeutic option to treat and prevent potentially deadly blood clots,” said Ann Farrell, M.D., director of the Division of Non-Malignant Hematology for the FDA Center for Drug Evaluation and Research.
A few months later, the FDA authorized children ages 5-11 to be injected with the Pfizer COVID-19 shot.
FDA Approves First Oral Blood Thinning Medication for Children
For Immediate Release:June 21, 2021
Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days. The FDA also approved Pradaxa oral pellets to prevent recurrent clots among patients 3 months to less than 12 years old who completed treatment for their first venous thromboembolism.