First oral blood thinner for treatment of children with venous thromboembolism

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Dabigatran has been accorded US FDA approval as the first oral blood thinner for use in children aged 3 months to those younger than 12 years. At present, the only other approved blood thinner to treat venous thromboembolism (VTE) in children is dalteparin, which is administered as a subcutaneous injection

Formulations available

  • Pellets for children aged 3 months to 12 years of age
  • Capsules for children aged ≥8 years

Approved indications for dabigaran pellets

  • Treatment of venous thromboembolism (VTE), directly after children have been treated with the injectable blood thinner for at least 5 days.
  • Prevention of recurrent clots in children who have completed treatment for their first venous thromboembolism.

Approved indications for dabigatran capsules

  • Treatment of blood clots in patients ≥8 years with VTE directly after they have been treated with a blood thinner given by injection for at least five days
  • Prevention of recurrent clots in patients ≥8 years who completed treatment for their first venous thromboembolism.

Side effects: Gastrointestinal symptoms, bleeding (sometimes it may be serious and fatal bleeding).

Contraindications: Patients with bioprosthetic heart valves or triple-positive antiphospholipid syndrome

The label carries a Boxed warning stating that early treatment discontinuation may increase the risk of blood clots and that blood accumulation within parts of the spinal cord (spinal or epidural hematomas) in patients undergoing spinal procedures may cause serious side effects.

(Source: US FDA and Medpage Today, June 21, 2021)