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FDA Drug Safety Podcast: FDA recommends against use of Revatio in children with pulmonary hypertension

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Narrator: Welcome to the FDA Drug Safety Podcast from the Division of Drug Information. Today’s topic: FDA recommends against use of Revatio in children with pulmonary hypertension

LCDR Jennifer Shepherd, a U.S. Public Health Service pharmacist in the Division, will provide you with additional information about this Communication.

Guest Speaker: On August 30, 2012, the FDA issued a Drug Safety Communication recommending that Revatio, active ingredient sildenafil, not be prescribed to children (ages 1 through 17) for pulmonary arterial hypertension, or PAH. This recommendation against use is based on a recent long-term clinical pediatric trial showing that: (1) children taking a high dose of Revatio had a higher risk of death than children taking a low dose and (2) the 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 information, 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 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 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; FDA is requiring Pfizer, the manufacturer of Revatio, to evaluate Revatio’s effect on the risk of death in adults with PAH.

At this time FDA recommends that Healthcare Professionals be aware of the following:

  • 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 maximum recommended dose of Revatio for adult patients with PAH is 20 mg three times a day.
  • Adverse events involving Revatio should be reported to the FDA MedWatch program at www.fda.gov/medwatch.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information.  A link to this communication, including the complete Data Summary, can be found at www.fda.gov/DrugSafetyCommunications.   If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

Follow us on Twitter @FDA_Drug_Info for up to the minute important drug information.  Know the moment it happens. 


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