Risk Alert — Revatio (sildenafil) — recommendation against use in children

September 4th, 2012

The FDA notified health care professionals that Revatio (sildenafil) should not be prescribed to children (ages 1 through 17) for pulmonary arterial hypertension (PAH).

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.

Treatment of PAH in children with this drug is an off-label use (not approved by FDA). A new warning stating the use of Revatio is not recommended in pediatric patients has been added to the Revatio labeling.

Revatio is a phosphodiesterase-5 inhibitor 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 (WHO Group I).

Health care 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.

August 30, 2012FDA drug safety communication

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