FDA Clarifies Revatio (sildenafil) Pediatric Use Warning

The U.S. Food and Drug Administration (FDA) has issued a Drug Safety Communication clarifying its previous recommendation regarding prescription of Revatio (sildenafil) for children with pulmonary arterial hypertension (PAH). The FDA recommended against off-label use of Revatio in the patient population in August 2012.

Revatio is indicated in the treatment of PAH in adults but not recommended in children. The previous recommendation is based on observations of increasing mortality with increasing doses of the drug in a long-term clinical trial in pediatric patients with PAH.

The agency stated, “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. 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 drug is manufactured by pharmaceutical giant Pfizer. At the time, the company responded that it believes the benefit/risk profile for the use of Revatio in adults with PAH remains favorable. Pfizer stated that it will continue to work with the FDA to understand the observation in the pediatric study and any possible implications in adults with PAH.

The FDA said healthcare professionals should consider whether benefits of treatment with Revatio are likely to outweigh potential risks for each patient. However, the agency did not retract its previous recommendation. “The evidence behind our initial recommendation has not changed; we are simply clarifying the strength of the warning communicated in the Revatio drug label,” the FDA concluded.