ArticlePloS one2015
Pediatric Drug Safety Surveillance in FDA-AERS: A Description of Adverse Events from GRiP Project.
Article in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pharmacoepidemiological safety studies in children: a systematic review.Pharmacoepidemiology and drug safety · 2016Pooled it
- Appropriateness and Abuse of Antipyretics, Anti-Inflammatory Drugs and Antibiotics in Children and Adults.Antibiotics (Basel, Switzerland) · 2026Review
- New perspectives for optimizing fever and pain management in pediatrics: evidence supporting therapeutic awareness in clinical practice.Italian journal of pediatrics · 2025Review
- When infection hurts: golden rules for managing pediatric skin and soft tissue infections.Italian journal of pediatrics · 2025Review
- BERT-based language model for accurate drug adverse event extraction from social media: implementation, evaluation, and contributions to pharmacovigilance practices.Frontiers in public health · 2024Article
- Characterization of Pediatric Reports in the US Food and Drug Administration Adverse Event Reporting System from 2010-2020: A Cross-Sectional Study.Therapeutic innovation & regulatory science · 2023Article
- No population left behind: Improving paediatric drug safety using informatics and systems biology.British journal of clinical pharmacology · 2022Review
- Evaluating risk detection methods to uncover ontogenic-mediated adverse drug effect mechanisms in children.BioData mining · 2021Article
- Active Extraction of Experience of Adverse Drug Reactions in Children.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2021Article
- Characteristics of Adverse Events Following Immunization Reporting in Children: The Japanese Adverse Drug Event Report Database.Vaccines · 2020Article
- Characteristics of pediatric adverse drug reaction reports in the Japanese Adverse Drug Event Report Database.BMC pharmacology & toxicology · 2020Article
- Article
- Pharmaco-epidemiological research on herbal medicinal products in the paediatric population: data from the PhytoVIS study.European journal of pediatrics · 2020Article
- Organizational capacities of national pharmacovigilance centres in Africa: assessment of resource elements associated with successful and unsuccessful pharmacovigilance experiences.Globalization and health · 2018Article
- An opportunity for clinical pharmacology trained physicians to improve patient drug safety: A retrospective analysis of adverse drug reactions in teenagers.F1000Research · 2018Article
- Signal of Miscarriage with Aripiprazole: A Disproportionality Analysis of the Japanese Adverse Drug Event Report Database.Drug safety · 2017Article
- Antibiotic-Induced Liver Injury in Paediatric Outpatients: A Case-Control Study in Primary Care Databases.Drug safety · 2017Article
- Neonatal adverse drug reactions: an analysis of reports to the French pharmacovigilance database.British journal of clinical pharmacology · 2016Article
- Drug Safety Monitoring in Children: Performance of Signal Detection Algorithms and Impact of Age Stratification.Drug safety · 2016Article
- Medication safety research by observational study design.International journal of clinical pharmacy · 2016Review
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Individual case safety reports (ICSRs) are a cornerstone in drug safety surveillance. The knowledge on using these data specifically for children is limited. We studied characteristics of pediatric ICSRs reported to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Public available ICSRs reported in children (0-18 years) to FAERS were downloaded from the FDA-website for the period Jan 2004-Dec 2011. Characteristics of these ICSRs, including the reported drugs and events, were described and stratified by age-groups. We included 106,122 pediatric ICSRs (55% boys and 58% from United States) with a median of 1 drug [range 1-3] and 1 event [1-2] per ICSR. Mean age was 9.1 years. 90% was submitted through expedited (15-days) (65%) or periodic reporting (25%) and 10% by non-manufacturers. The proportion and type of pediatric ICSRs reported were relatively stable over time. Most commonly reported drug classes by decreasing frequency were 'nervous system drugs' (58%), 'antineoplastics' (32%) and 'anti-infectives' (25%). Most commonly reported system organ classes were 'general' (13%), 'nervous system' (12%) and 'psychiatric' (11%) disorders. Duration of use could be calculated for 19.7% of the reported drugs, of which 14.5% concerned drugs being used long-term (>6 months). Knowledge on the distribution of the drug classes and events within FAERS is a key first step in developing pediatric specific methods for drug safety surveillance. Because of several differences in terms of drugs and events among age-categories, drug safety signal detection analysis in children needs to be stratified by each age group.
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