The FDA has notified healthcare professionals and their medical care organizations that Revatio (sildenafil, Pfizer) should not be prescribed to children (ages 1 through 17) for pulmonary arterial hypertension (PAH).
This recommendation against use, according to the agency, is based on a recent long-term clinical pediatric trial showing that:
- Children taking a high dose of Revatio had a higher risk of death than children taking a low dose; and
- The low doses of Revatio are not effective in improving exercise ability.
The FDA stressed that treatment of PAH in children with this drug is now an off-label, noting that with the new warning to the Revatio label, the use of Revatio is not recommended in pediatric patients.
Revatio is a phosphodiesterase-5 inhibitor used to treat PAH by relaxing the blood vessels in the lungs to reduce blood pressure. It is approved to improve exercise ability and delay clinical worsening of PAH in adult patients (WHO Group I).
Patients and caregivers are advised to not change the Revatio dose or stop taking Revatio without talking to a healthcare 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.
This decision was based on a randomized, double-blind, multicenter, placebo-controlled, parallel-group, dose-ranging clinical trial. In the trial, 234 patients with PAH, 1 to 17 years of age, were randomized to low-, medium-, or high-dose sildenafil (administered three times per day) or placebo for 16 weeks of treatment (Circulation 2012;125:324-334).
The additional information for healthcare professionals is:
- Use of Revatio, particularly chronic use, is not recommended in children. An unexpectedly higher risk of mortality was found in pediatric patients taking a high dose of Revatio when compared to pediatric patients taking a low dose.
- The maximum recommended dose of Revatio for adult patients with PAH is 20 mg three times a day.
- Report adverse events involving Revatio to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.