Revatio is a formulation of sildenafil, a phosphodiesterase-5 inhibitor that promotes vasodilation. Taken in 20-mg doses three times a day, it improves exercise ability and delays clinical worsening of pulmonary hypertension in adults and is approved for that indication. Clinicians have also used Revatio off label to treat children with pulmonary hypertension, but the Food and Drug Administration (FDA) now recommends against this. The recommendation is based on data from a long-term pediatric clinical trial that found a higher risk of death when a large dose of Revatio was used; the trial also found that there were no signs of improvement in exercise ability when a lower dose was used. A warning and information from the trial will be added to Revatio's label.

Other dosages of this drug (25 mg, 50 mg, and 100 mg) are sold under the trade name Viagra, which is used to treat erectile dysfunction.

The risk of death in adults from long-term use of Revatio isn't currently known. The FDA has now required the drug's manufacturer to evaluate that risk, but adult patients with pulmonary hypertension who are taking Revatio don't need to discontinue the drug. The FDA doesn't believe these safety concerns apply when the drug is used to treat erectile dysfunction because both the dosing regimen and the patient population are different than when the drug is used to treat pulmonary hypertension.

Nurses who prescribe or work with patients taking Revatio should provide education to both patients and families regarding this information from the FDA. To read the FDA Drug Safety Communication regarding Revatio, go to http://1.usa.gov/Pvw1Jg.