Sildenafil [Revatio]: FDA Clarifies Warning About Pediatric Use for Pulmonary Arterial Hypertension (PAH)

Last Updated on April 3, 2014 by Joseph Gut – thasso

March 31, 2014 –  The American Food and Drug Administration (FDA) is clarifying its previous recommendation related to prescribing Sidenafil [Revatio] for children with pulmonary arterial hypertension (PAH). Note that the pharmacologically active compound sildenafil is also the pharmacologically active principle in Sildenafil [Viagra] which is on the market to treat erectile disfunction.

Sildenafil [Revatio] is FDA-approved only to treat PAH in adults, not in children; however, health care professionals must consider whether the benefits of treatment with the drug are likely to outweigh its potential risks for each patient. FDA revised the Sildenafil [Revatio] drug label in August 2012, adding a warning stating that “use of Sidenafil [Revatio], particularly chronic use, is not recommended in children.” This recommendation was based on an observation of increasing mortality with increasing Sidenafil [Revatio] doses in a long-term clinical trial in pediatric patients with PAH. FDA issued a Drug Safety Communication at that time. There may be situations in which the benefit-risk profile of Sildenafil [Revatio] may be acceptable in individual children, for example, when other treatment options are limited and Sildenafil [Revatio] can be used with close monitoring.

BACKGROUND: The purpose of the August 2012 recommendation was to raise awareness of clinical trial results showing a higher risk of mortality in pediatric patients taking a high dose of Sildenafil [Revatio] when compared to pediatric patients taking a low dose. This recommendation was not intended to suggest that Sildenafil [Revatio] should never be used in children; however, some health care professionals have interpreted this information as a contraindication, and have refused to prescribe or administer the drug.

RECOMMENDATION: The evidence behind FDAs initial recommendation has not changed; this communication is clarifying the strength of the warning communicated in the Sildenafil [Revatio] drug label.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program, amongst other routes of communication,  online at  www.fda.gov/MedWatch/report.htm.

More information is available at 03/31/2014 – Drug Safety Communication – FDA] and [01/2014 – Revatio (sildenafil) Prescribing Information

Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

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