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FDA Clarifies Warnings for Revatio (sildenafil) in Children


April 1, 2014 — The U.S. Food and Drug Administration (FDA) has published a Drug Safety Communication to clarify warnings about using Revatio (sildenafil) in children. The FDA is concerned that doctors may not prescribe the medication when it is actually necessary.

The original Drug Safety Communication, published on August 20, 2013, stated:

“Use of Revatio, particularly chronic use, is not recommended in children. An unexpectedly higher risk of mortality was found in pediatric patients taking a high dose of Revatio when compared to pediatric patients taking a low dose.”

The FDA is concerned that the original warning was too strongly-worded, and was misinterpreted by some doctors who think Revatio should never be prescribed in children. The FDA has clarified that Revatio can still be prescribed to children if the benefits outweigh the risks — for example, if other treatment options are limited, or if the child is being monitored very closely.

Revatio is still not approved for use in children, but it is sometimes used “off-label” to treat pulmonary arterial hypertension (PAH), or chronic high blood pressure in the lungs. Without treatment, PAH causes shortness of breath, dizziness, fatigue, chest pain, and can lead to enlargement of the heart. Over time, PAH can cause congestive heart failure and death.

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