The FDA has come out with a statement recommending against the use of Revatio (sildenafil) to treat pulmonary arterial hypertension in children under 17. Higher doses at this age, they say, can increase risk of death. Revatio has been used in many pediatric applications, and it's a bit of a surprise to learn that it never was in fact approved for use in kids, so it's being used off label. In fact, the Revatio label will soon have a warning about use by youth.
Given the benefits of Revatio, it's likely doctors will continue to use it for pediatric treatment without the FDA's blessing.
