FDA Drug Safety Communication

FDA is recommending that Revatio (sildenafil) not be prescribed to children (ages 1 through 17) for pulmonary arterial hypertension (PAH; high pressure in the blood vessels leading to the lungs). This recommendation against use is based on a recent long-term clinical pediatric trial showing that: (1) children taking a high dose of Revatio had a higher risk of death than children taking a low dose and (2) the low doses of Revatio are not effective in improving exercise ability. Most deaths were caused by pulmonary hypertension and heart failure, which are the most common causes of death in children with PAH.

Revatio has never been approved for the treatment of PAH in children, and in light of the new clinical trial information, off-label (not approved by FDA) use of the drug in pediatric patients is not recommended. The following new information is being added to the Revatio drug label:

- A new warning stating the use of Revatio is not recommended in pediatric patients

- Results of the Revatio trial in pediatric patients

Revatio is approved to improve exercise ability and delay clinical worsening of PAH in adult patients (WHO Group I). The current Revatio label recommends avoiding doses higher than 20 mg, given three times a day. The effect of Revatio on the risk of death with long-term use in adults is unknown; FDA is requiring the manufacturer of Revatio (Pfizer) to evaluate Revatio's effect on the risk of death in adults with PAH.

View the full FDA Drug Safety Communication on FDA.gov