Safety assessment of sildenafil use in neonates: a real-world data analysis based on the FDA adverse event reporting system (FAERS)

ABSTRACT

Background

The safety of neonatal sildenafil use remains uncertain. This study aimed to investigate adverse events (AEs) associated with sildenafil use in neonates.

Research design and methods

We collected data on AEs associated with sildenafil use in neonates from the US Food and Drug Administration Adverse Event Reporting System database, spanning from its inception of the database in 2004 to 2023. Disproportionality measures were employed to analyze the correlation between AEs and sildenafil.

Results

Sildenafil was identified as the primary suspect drug in 75 AE reports, involving 214 AEs. Three system organ classes, namely, eye disorders, hepatobiliary disorders, and vascular disorders were associated with sildenafil use. Six preferred terms, namely, flushing, retinopathy of prematurity, hyperbilirubinemia, pulmonary hemorrhage, hypotension, and diarrhea were associated with sildenafil use. Notably, hyperbilirubinemia and pulmonary hemorrhage were previously unreported AEs associated with sildenafil use.

Conclusion

The results highlight the ongoing uncertainty surrounding the safety of neonatal sildenafil use and provide vital support for risk monitoring and identification in neonates receiving sildenafil. Additionally, the study underscores the need for continuous safety surveillance in neonates treated with sildenafil and suggests further exploration of the precise causal relationships between AEs and sildenafil.

KEYWORDS:

• Adverse event
• disproportionality measures
• FAERS database
• neonate
• sildenafil

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Data availability statement

Data generated in this study will be made available by the corresponding author upon reasonable request.

Author contribution statement

Jia Zhang and Rui Cheng designed the study. Bo Wang and Jia Zhang generated data. Bo Wang and Rui Cheng analyzed the data. Bo Wang wrote the manuscript. Jia Zhang and Rui Cheng revised the manuscript. All authors approved the final version of the manuscript.

Acknowledgments

We thank Jing Zhang from Fudan University Shanghai Fifth People’s Hospital for providing technical support for working with the R software. We thank Bullet Edits Limited for English language editing and proofreading.

Ethics statement

Given that the FAERS database is publicly accessible and anonymous, informed consent and ethical approval were exempted for this study, in strict adherence to the prevailing local laws and regulations.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2024.2383710

Additional information

Funding

This paper was not funded.