FDA clarifies warning about Revatio use in children with PAH

The FDA today released a statement clarifying its previous recommendation related to the prescription of sildenafil for children with pulmonary arterial hypertension. The drug is FDA approved only for the treatment of pulmonary arterial hypertension in adults. However, according to the new statement, health care professionals must consider whether the benefits of treatment are likely to outweigh its potential risks for each patient.

The statement follows an FDA Drug Safety Communication released in August 2012, when the FDA revised the Revatio drug label and added a warning that chronic use of Revatio is not recommended in children. The recommendation was based on long-term clinical trial results that showed increased mortality with higher Revatio doses in pediatric patients with PAH, according to the new statement.

The FDA now states that 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.”

The FDA makes clear in the statement that “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 evidence behind the recommendation in August 2012 has not changed. The purpose of today’s statement was to clarify the strength of the warning communicated in the Revatio drug label.