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FDA Warns Against Use of Revatio (Sildenafil) in Children

High doses increase risk of death (Aug. 30)

On August 30, the FDA recommended that Revatio (sildenafil; Pfizer) not be prescribed to children (ages 1 through 17 years) for pulmonary arterial hypertension (PAH). This recommendation against use is based on a recent long-term clinical pediatric trial, which showed that: 1) children taking high doses of Revatio had a higher risk of death than did children taking low doses, and 2) low doses of Revatio are not effective in improving exercise ability. Most deaths were caused by pulmonary hypertension and heart failure, which are the most common causes of death in children with PAH.

Revatio has never been approved for the treatment of PAH in children, and in light of the new clinical trial data, off-label use of the drug in pediatric patients is not recommended.

The following new information is being added to the Revatio drug label:

  • A new warning stating that the use of Revatio is not recommended in pediatric patients
  • Results of the Revatio trial in pediatric patients

Revatio is approved to improve exercise ability and to delay clinical worsening of PAH in adult patients. The current Revatio label recommends avoiding doses higher than 20 mg, given three times a day. The effect of Revatio on the risk of death with long-term use in adults is unknown; the FDA is requiring Pfizer to evaluate the effect of Revatio on the risk of death in adults with PAH.

For more information, visit the FDA Web site.

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