FDA Clarifies Warnings for Revatio (sildenafil) in Children

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April 1, 2014 — The U.S. Food and Drug Administration (FDA) is clarifying warnings they issued two years ago against using Revatio (sildenafil) in children, fearing that doctors may not prescribe the medication when it is actually needed.

The latest Drug Safety Communication, published on March 31, 2014, is an update to a previous Drug Safety Communication published on August 20, 2013.

The original warning 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 because some doctors think this means Revatio should never be used in children, when in fact there are certain circumstance in which it could be appropriate — for example, if other treatment options are limited, or if the child is being closely monitored. Healthcare professionals should consider the risks and benefits for each patient.

Revatio is still not approved by the FDA for children. However, it is sometimes used to treat pulmonary arterial hypertension (PAH), or high blood pressure in the lungs. PAH causes shortness of breath, dizziness, fatigue, and enlargement of the right side of the heart. Over time, it can lead to congestive heart failure. Other complications include swelling of the ankle or leg and chest pain. Revatio treats PAH by relaxing blood vessels in the lungs, which helps reduce blood pressure.

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