Safety and tolerability considerations in the use of sildenafil for children with pulmonary arterial hypertension.

Published online

Journal Article (Review)

Sildenafil is a phosphodiesterase type-5 inhibitor approved for treatment of pulmonary arterial hypertension (PAH) in adults. Data from pediatric trials demonstrate a similar acute safety profile to the adult population but have raised concerns regarding the safety of long-term use in children. Interpretation of these trials remains controversial with major regulatory agencies differing in their recommendations - the US Food and Drug Administration recommends against the use of sildenafil for treatment of PAH in children, while the European Medicines Agency supports its use at "low doses". Here, we review the available pediatric data regarding dosing, acute, and long-term safety and efficacy of sildenafil for the treatment of PAH in children.

Full Text

Duke Authors

Cited Authors

  • Dodgen, AL; Hill, KD

Published Date

  • 2015

Published In

Volume / Issue

  • 7 /

Start / End Page

  • 175 - 183

PubMed ID

  • 26719728

Pubmed Central ID

  • 26719728

International Standard Serial Number (ISSN)

  • 1179-1365

Digital Object Identifier (DOI)

  • 10.2147/DHPS.S65571


  • eng

Conference Location

  • New Zealand