The U.S. Food and Drug Administration (FDA) has approved a new use for the prescription drug rivaroxaban, known by the brand name Xarelto. It is now approved to help prevent dangerous blood clots in children aged 2 years and older who were born with a heart defect and have had a specific open-heart surgery called the Fontan procedure. These children have a higher risk of blood clots forming, which can travel to the lungs or brain and cause serious problems. Xarelto is a type of medicine known as a blood thinner, or anticoagulant, which helps reduce this risk.
This approval means that doctors now have an oral (taken by mouth) medication option for these young patients. Previously, Xarelto was already approved for adults and for treating blood clots in children. This new approval specifically addresses the long-term need to prevent clots from forming in the first place in this unique group. It is important to understand that this is for a very specific situation and is not a general treatment for all children with heart problems.
As with all medications, there are important considerations. All blood thinners carry a risk of bleeding. The decision to use this medicine involves carefully weighing the benefit of preventing a clot against the risk of bleeding for each individual child. The FDA's approval is based on a review of evidence showing the drug's benefit for this specific use.
One important note for families is that this approval does not change the fundamental need for close care from a specialist. If you are a parent or caregiver of a child with congenital heart disease, this news means there is a potential new option to discuss with your child's cardiology team. They are the best people to determine if this treatment is appropriate for your child's specific health situation.