Objective: In view of the recent U.S. Food and Drug Administration’s warning against the use of sildenafil in pediatric patients, we aimed to provide an updated overview of the dosing and safety of sildenafil in infants and to explore the relevance of the present safety concerns to the infant population.
Data Source: The National Library of Medicine PubMed and Cochrane Database of Systematic Reviews were searched using the following terms: Sildenafil AND (infant OR infants OR newborn OR newborns OR child OR children OR childhood OR pediatric OR pediatrics OR paediatric OR paediatrics).
Study Selection: Studies presenting original clinical data regarding the dosing, use, or safety of sildenafil in infants with pulmonary hypertension would be included.
Data Extraction: Of the 49 included studies, case reports and case series were the most common type of publications (n = 25). The identified trials included 625 children, with more than 140 infants. Persistent pulmonary hypertension of the newborn and pulmonary hypertension associated with other conditions were the most common underlying diagnoses.
Conclusion: There is currently no evidence of serious adverse event in infants exposed to sildenafil. Present safety concerns regarding the use of sildenafil in pediatric patients should be further explored before being applied to infant population. Sildenafil remains a valuable option for the treatment of pulmonary hypertension in young infants. Prospective studies should be designed in such a way that they include a safety assessment to evaluate potential adverse outcomes of sildenafil therapy in this population.
1Division of Pediatric Clinical Pharmacology, Children’s National Medical Center, George Washington University School of Medicine and Health Sciences, Washington, DC.
2Duke Clinical Research Institute, Durham, NC.
3Department of Pediatrics, Duke University, Durham, NC.
4Department of Pediatrics, Children’s National Medical Center, George Washington University School of Medicine and Health Sciences, Washington, DC.
5Department of Pharmacology and Physiology, Children’s National Medical Center, George Washington University School of Medicine and Health Sciences, Washington, DC.
6Intensive Care, Erasmus Medical Center-Sophia Children’s Hospital, Rotterdam, The Netherlands.
7Department of Paediatric Pharmacology, University Children’s Hospital Basel, Switzerland.
* See also p. 377.
Dr. Smith consulted for Pfizer (DSMB member) and received support for article research from the National Institutes of Health (NIH) (DHHS-1R18AE000028-01, NIH-1K23HD060040-01). Dr. van den Anker served as a board member for ENDO Pharmaceuticals (Chaur DSMB); consulted for GSK, Reckitt Benckiser, and UCB; and received grant support from the NIH (NIH-5U54HD071601, NIH-5K24DA027992). Dr. Samiee-Zafarghandy disclosed that she does not have any potential conflicts of interest.
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