FDA Drug Safety Podcast: FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension

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Welcome to the FDA Drug Safety Podcasts for healthcare professionals from the Division of Drug Information. This communication is in follow-up to the August 30, 2012 FDA Drug Safety Communication.

On March 31, 2014, the FDA is clarifying its previous recommendation related to prescribing Revatio (active ingredient sildenafil) for children with pulmonary arterial hypertension (or PAH). Revatio is FDA approved only to treat PAH in adults, not in children; however, healthcare professionals must consider whether the benefits of treatment with the drug are likely to outweigh its potential risks for each patient.

In August 2012, FDA added the warning “use of Revatio, particularly chronic use, is not recommended in children” to Revatio’s drug label. A FDA Drug Safety Communication was also issued.

This recommendation was based on clinical trial results showing a higher mortality risk in pediatric patients taking a high dose of Revatio when compared to pediatric patients taking a low dose. This recommendation was not intended to suggest Revatio should never be used in children; however, some healthcare professionals interpreted this information as a contraindication. We recognize there may be situations in which Revatio’s benefit-risk profile may be acceptable in individual children, for example, when other treatment options are limited and Revatio can be used with close monitoring.

The evidence behind our initial recommendation has not changed; we’re simply clarifying the strength of the warning in Revatio’s drug label.

Thank you for listening. A link to the full communication can be found at www.fda.gov/DrugSafetyCommunications. Report side effects involving Revatio to FDA’s MedWatch program at www.fda.gov/medwatch. And if you have drug questions, you can reach us at druginfo@fda.hhs.gov.


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