ArticleMed (New York, N.Y.)2022
A database of pediatric drug effects to evaluate ontogenic mechanisms from child growth and development.
Article in Med (New York, N.Y.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
7 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.
- A Systematic Review and a VigiBase Study of Accidental Clozapine Intoxications in Children and Adolescents.Human psychopharmacology · 2026Pooled it
- Pediatric Developmental Safety Assessment and New Approach Methodologies: US FDA/Triangle CERSI Workshop Report.Clinical pharmacology and therapeutics · 2026Review
- A manufacturer-aware cross-system benchmark for pediatric pharmacovigilance signal concordance.Frontiers in pharmacology · 2026Article
- Machine learning prediction of pediatric adverse drug reactions using consensus-derived scarce data.Communications chemistry · 2025Article
- Pediatric Developmental Safety Assessment: Are We Ready for the Next Thalidomide?Clinical pharmacology and therapeutics · 2025Article
- OnSIDES database: Extracting adverse drug events from drug labels using natural language processing models.Med (New York, N.Y.) · 2025Article
- LEVERAGING UNSTRUCTURED DATA IN ELECTRONIC HEALTH RECORDS TO DETECT ADVERSE EVENTS FROM PEDIATRIC DRUG USE - A SCOPING REVIEW.medRxiv : the preprint server for health sciences · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 1 institution in 1 country.
Funding
Abstract
backgroundAdverse drug effects (ADEs) in children are common and may result in disability and death, necessitating post-marketing monitoring of their use. Evaluating drug safety is especially challenging in children due to the processes of growth and maturation, which can alter how children respond to treatment. Current drug safety-signal-detection methods do not account for these dynamics.
methodsWe recently developed a method called disproportionality generalized additive models (dGAMs) to better identify safety signals for drugs across child-development stages.
findingsWe used dGAMs on a database of 264,453 pediatric adverse-event reports and found 19,438 ADEs signals associated with development and validated these signals against a small reference set of pediatric ADEs. Using our approach, we can hypothesize on the ontogenic dynamics of ADE signals, such as that montelukast-induced psychiatric disorders appear most significant in the second year of life. Additionally, we integrated pediatric enzyme expression data and found that pharmacogenes with dynamic childhood expression, such as CYP2C18 and CYP27B1, are associated with pediatric ADEs.
conclusionsWe curated KidSIDES, a database of pediatric drug safety signals, for the research community and developed the Pediatric Drug Safety portal (PDSportal) to facilitate evaluation of drug safety signals across childhood growth and development.
fundingThis study was supported by grants from the National Institutes of Health (NIH).
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.