| アブストラクト | BACKGROUND: Acetaminophen, ibuprofen, and indomethacin are widely used as first-line drugs for patent ductus arteriosus (PDA) closure in preterm neonates. However, their relative safety profiles remain unclear. METHODS: Adverse event reports related to the first-line drugs used in PDA and neonates in general were retrieved from the US Food and Drug Authority (FDA) Adverse Event Reporting System. Deduplicated reports were analyzed using proportional reporting ratios and reporting odds ratios to identify disproportionality safety signals between drugs. RESULTS: A total of 969 unique reports related to the first-line drugs used in PDA and 499 reports in the neonatal period were included. Acetaminophen signals primarily involved the liver, while ibuprofen and indomethacin signals pertained to gastrointestinal, renal, vascular, and mortality outcomes. Higher occurrences of death were reported with indomethacin and ibuprofen compared with acetaminophen. CONCLUSION: This first comparison of PDA drug safety profiles from spontaneous reports highlights some differences, with acetaminophen potentially conferring a safer adverse effect profile overall. While limitations include missing data and reporting biases, the signals warrant further validation. Given its comparable efficacy to ibuprofen, as demonstrated in other studies, acetaminophen has the potential to be preferred as an initial medical therapy for PDA. |
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| ジャーナル名 | Paediatric drugs |
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| 投稿日 | 2024/10/6 |
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| 投稿者 | Sridharan, Kannan; Sivaramakrishnan, Gowri |
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| 組織名 | Department of Pharmacology and Therapeutics, College of Medicine and Health;Sciences, Arabian Gulf University, Manama, Kingdom of Bahrain.;skannandr@gmail.com.;Dental Post Graduate Training Department, PHCC, Manama, Kingdom of Bahrain. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39367998/ |
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