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April 16, 2014
FDA: Sildenafil Okay in Some Circumstances for Children
With PAH Washington, D.C.—In a twist, the FDA is concerned that a 2012 warning may have been taken too seriously. Two years ago, an FDA Drug Safety Communication was issued, recommending that Revatio (sildenafil) not be prescribed to children under age 17 for pulmonary arterial hypertension (PAH). Now, the agency is clarifying its previous recommendation, noting that, while Revatio is FDA-approved only to treat PAH in adults, healthcare professionals must consider whether the benefits of treatment with the drug are likely to outweigh its potential risks for each patient, including children. The Revatio drug label was revised in August 2012, adding a warning stating that “use of Revatio, particularly chronic use, is not recommended in children.” The revision was based on an observation of increasing mortality with increasing Revatio doses in a long-term clinical trial in pediatric patients with PAH. “The purpose of the recommendation was to raise awareness of clinical trial results showing a higher risk of mortality in pediatric patients taking a high dose of Revatio when compared to pediatric patients taking a low dose,” the FDA said in a communication document. “This recommendation was not intended to suggest that Revatio should never be used in children; however, some health care professionals have interpreted this information as a contraindication, and have refused to prescribe or administer the drug. “We recognize there may be situations in which the benefit-risk profile of Revatio may be acceptable in individual children, for example, when other treatment options are limited and Revatio can be used with close monitoring.” The FDA underscored that the evidence behind the initial recommendation has not changed, and that it just is clarifying the strength of the warning communicated in the Revatio drug label. The active ingredient in Revatio, a phosphodiesterase-5 inhibitor used to treat PAH by relaxing the blood vessels in the lungs, is also marketed in the prescription product Viagra, approved for use in adult males with erectile dysfunction. The FDA said at the time of the 2012 communication that it did not believe the safety concerns applied to the use of Viagra, given the differences in patient population and the variance in dosing regimens. Both Revatio and Viagra are marketed by Pfizer Inc.
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