Revatio (sildenafil) Warning against Use in Children

Pediatrics, Cardiology and Pulmonology healthcare professionals are warned by the FDA that Revatio (sildenafil) should not be prescribed to children aged 1 to 17. Treatment of children for pulmonary arterial hypertension (PAH) with Revatio is NOT approved by the FDA.

Background of Revatio (sildenafil)

Revatio (sildenafil) is a phosphodiesterase-5 inhibitor. Its use is for the treatment of pulmonary arterial hypertension (PAH) and the delay of PAH clinical worsening in adult patients. FDA Alert on Revatio (sildenafil)

FDA evaluated data from a recent long-term clinical pediatric trial showing that higher doses of Revatio to children led to higher risk of death and that low doses of Revatio are not effective.

Therefore, the use of Revation in children is off-label and the new warning is added to the drug’s labeling.

FDA Recommendation on Revatio (sildenafil)

“Patients and caregivers are advised to not change the Revatio dose or stop taking Revatio without talking to a health care professional. Healthcare professionals were reminded that use of this product, particularly chronic use, in children is an off-label indication, not approved by FDA, and is not recommended. See the Drug Safety Communication for the Data Summary from the randomized, double-blind, placebo-controlled clinical trial of 234 patients with PAH, 1 to 17 years of age with mild to moderate symptoms at baseline.”

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