ArticleBritish journal of clinical pharmacology2016
Neonatal adverse drug reactions: an analysis of reports to the French pharmacovigilance database.
Article in British journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed, 23 citations in OpenAlex.
- Differential Analysis of Neonatal Adverse Drug Events from Intrauterine and Extrauterine Exposure: Insights into Administration Routes Using the FAERS Database.Zeitschrift fur Geburtshilfe und Neonatologie · 2026Article
- Adverse events in the neonatal intensive care unit identified by triggers.Frontiers in pharmacology · 2025Article
- Prevalence and Patterns of Potentially Inappropriate Prescribing by Brazilian Dentists for Pediatric Patients: A Cross-Sectional Study.BioMed research international · 2025Article
- Prevalence of key potentially inappropriate drugs use in pediatrics: a cross-sectional study.BMC pediatrics · 2024Observational
- The efficacy and safety of nirsevimab for the prevention of RSV infection among infants: A systematic review and meta-analysis.Frontiers in pediatrics · 2023Review
- Fetal glucocorticoid exposure leads to sex-specific changes in drug-transporter function at the blood-brain barrier in juvenile guinea pigs.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2022Article
- Genophenotypic Factors and Pharmacogenomics in Adverse Drug Reactions.International journal of molecular sciences · 2021Review
- Construction and analysis of a database for medication errors in a pharmacovigilance centre-the Moroccan experience.European journal of clinical pharmacology · 2021Article
- Characteristics of pediatric adverse drug reaction reports in the Japanese Adverse Drug Event Report Database.BMC pharmacology & toxicology · 2020Article
- Article
- Reported Adverse Drug Reactions in Infants: A Nationwide Analysis in Malaysia.Frontiers in pharmacology · 2017Article
- Neonatal adverse drug reactions: an analysis of reports to the French pharmacovigilance database.British journal of clinical pharmacology · 2016Article
- Ranitidine-induced Thrombocytopenia in a Neonate - A Case Report and Review of Literature.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAGArticle
Corrections and comments
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Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTerm and preterm neonates are at high risk for serious adverse drug reactions (ADRs).
methodsA descriptive study of reports registered in the French pharmacovigilance database from 1986 to 2012 were obtained. All reports concerning neonates (≤1 month of life) with direct drug exposure were retrieved. Characteristics of the reports, including reported ADR(s), drug(s) and the causality assessment using the French causality assessment method, were described.
resultsA total of 1688 reports were analyzed and more than half of them were classified as serious (n = 995). Median age at ADR occurrence was 9 days. Overall, 3127 ADRs were described in these reports in relation to 2238 suspect/interacting drugs. The most commonly reported system organ classes (SOCs) were injury, poisoning and procedural complications (16%), general disorders and administration site conditions (12.5%) and blood and lymphatic system disorders (12%). In the majority of ADRs reported (73%), infants fully recovered and less than 4% of neonates deceased as a consequence of the reported ADR. One out of five ADRs was associated with drug administration errors. Therapeutic classes commonly incriminated were anti-infectives, nervous system and alimentary tract drugs. Substances most frequently related to serious ADRs were zidovudine, ibuprofen and nevirapine. Among the 10 most frequently encountered drug-ADR pairs, two substances were mainly implicated, zidovudine in haematological adverse reactions and phytomenadione in maladministrations.
conclusionsAnti-infective drugs, mainly antiretroviral therapy, account for the majority of ADRs reported in neonates. The specific issue of drug maladministration and medication errors remains to be addressed in neonates.
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