FDA Recommends Against Revatio Use in Children

The FDA notified healthcare professionals and their medical care organizations that Revatio (sildenafil citrate tablets and solution for injection; Pfizer) should not be prescribed to children (ages 1–17) for pulmonary arterial hypertension (PAH).

This recommendation is based on a long-term randomized, double-blind, placebo-controlled pediatric trial (n=234, ages 1–17) of patients with PAH wit mild-to-moderate symptoms at baseline. Study results showed that:

  • Children taking a high dose of Revatio had a higher risk of death than children taking a low dose.
  • Low doses of Revatio were not effective in improving exercise ability.

A new warning stating that the use of Revatio is not recommended in pediatric patients has been added to the labeling; treatment of PAH in children is an off-label use.

Revatio, a phosphodiesterase-5 inhibitor, is used to treat pulmonary arterial hypertension by relaxing the blood vessels in the lungs to reduce blood pressure and is approved to improve exercise ability and delay clinical worsening of PAH in adult patients. Patients and caregivers are advised to not change the Revatio dose or stop taking Revatio without talking to a health care professional.

For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm317743.htm