FDA Clarifies Its Position on Revatio Use in Children: It May Be Acceptable If Other Treatment Options Are Limited

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FDA approval for PAH drug

FDA warning for PAH drugThe Food and Drug Administration clarified its previous recommendation related to prescribing Revatio (sildenafil; Pfizer) for children with pulmonary arterial hypertension (PAH), the Monthly Prescribing Reference reports.

In August 2012, the FDA revised the Revatio drug label and warned that the use of the drug, particularly for chronic use, stating that it “is not recommended in children.” This recommendation was based on data from a long-term clinical trial in pediatric patients that showed increasing mortality rates with increasing Revatio doses.

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Revatio is approved only to treat PAH in adults, but healthcare providers must consider whether the benefits of treatment are likely to outweigh the risks for each patient. The Agency now notes that there may be circumstances in which the benefit-risk profile of Revatio may be acceptable in individual children, if other treatment options are limited.

Although the recommendation from August 2012 was not intended to suggest that Revatio should never be prescribed for pediatric use, some healthcare providers have misinterpreted the information as a contraindication and have refused to prescribe the drug. The Agency is not changing its initial recommendation nor the evidence behind it, but now clarifies the strength of the warning as stated in the drug label.

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A phosphodiesterase-5 inhibitor, Revatio is 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.