ReviewDrug safety2022
Pediatric Drug Safety Surveillance: A 10-Year Analysis of Adverse Drug Reaction Reporting Data in Calabria, Southern Italy.
Review in Drug safety, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
9 citing papers in PubMed, 13 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
- Respiratory drugs and psychiatric adverse events in children and adolescents: a pharmacovigilance study based on the FAERS database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Risk prediction models for adverse drug reactions in pediatrics: a scoping review.International journal of clinical pharmacy · 2026Article
- Assessment of mandatory declaration excipients in pediatric off label prescriptions in Spain.Scientific reports · 2025Observational
- Probing the in-depth analysis of Serious Adverse Drug Reactions in a tertiary care hospital of Central India.Exploratory research in clinical and social pharmacy · 2025Article
- Evaluating the Economic Impact of the PedAMINES App in Reducing Medication Errors in Pediatric Emergency Care: Cost-Effectiveness Analysis.Journal of medical Internet research · 2024Article
- Two Years of Active Pharmacovigilance Surveillance and Therapeutic Reconciliation in Frail Populations: The MEAP 3.0 Study.Journal of clinical medicine · 2023Article
- Safety profiles of methylphenidate, amphetamine, and atomoxetine: analysis of spontaneous reports submitted to the food and drug administration adverse event reporting system.Frontiers in pharmacology · 2023Article
- An Unusual Localized Reaction of Conjunctivitis with Systemic Use of Ketoprofen: A Case Report.Case reports in ophthalmologyArticle
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe paucity of pediatric clinical trials has led to many medicines frequently prescribed to children without a license for use in pediatrics, resulting in an increased risk of adverse drug reactions. Pharmacovigilance databases remain, among others, a valuable tool for evaluating pediatric drug safety in the real-life setting.
objectiveWe aimed to characterize pediatric adverse drug reactions reported in the Italian Pharmacovigilance database coming from the Calabria region (Southern Italy) over 10 years.
methodsAll Individual Case Safety Reports (ICSRs) concerning individuals aged under 18 years were extracted from 2010 to 2019. Duplicate and vaccine ICSRs were excluded. The remaining ICSRs were analyzed with respect to patients' demographic data, suspected drugs, and category of adverse drug reactions across different age groups.
resultsAmong 6529 selected ICSRs, 395 pediatric ICSRs corresponding to 556 adverse drug reactions were analyzed. From 2010 to 2015, an increasing number of ICSRs were observed, but the reporting rate decreased after 2015. The highest proportion of ICSRs concerned children and adolescents. Around 52% of ICSRs involved boys: a trend observed in all age groups excluding newborns. Sixty ICSRs were serious and among them, 75% required hospitalization mainly in children and adolescents. Most of the ICSRs were issued by physicians (64.1%), followed by other healthcare professionals (22.5%) and pharmacists (9.9%). Anti-infective agents for systemic use and skin disorders were, respectively, the most frequently reported drug group and adverse drug reaction category.
conclusionsThis study provides an overview of adverse drug reactions reported in the pediatric population of the Calabria region and emphasizes the need for strengthening the surveillance in specific age subgroups and on given drugs in relation to their pattern of use.
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