ReviewEuropean journal of clinical pharmacology2012
Off-label and unlicensed medicine use and adverse drug reactions in children: a narrative review of the literature.
Review in European journal of clinical pharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 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
42 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Cardiometabolic adverse effects of long-term antipsychotic treatment in children and adolescents with non-psychotic disorders: a systematic review of available evidence.European child & adolescent psychiatry · 2025Pooled it
- Advantages of Ciprofol with Special Consideration of Pediatric Anesthesia.Children (Basel, Switzerland) · 2026Review
- Antipsychotic Treatment and Longitudinal Body Mass Index Trajectories in Youth with and Without Autism Spectrum Disorder.Journal of clinical medicine · 2026Article
- "We've managed to find our own path of how we do it": exploring parental perceptions of using age-inappropriate formulations at home-a qualitative study.Frontiers in pediatrics · 2026Article
- A framework for conducting clinical trials involving 3D printing of medicines at the point-of-care.Drug delivery and translational research · 2025Review
- Off-Label, but on-Evidence? A Review of the Level of Evidence for Pediatric Pharmacotherapy.Clinical pharmacology and therapeutics · 2022Review
- New Information on Old Medicinal Products: A Cross-Sectional Analysis of Guidance for Paediatric Use for Substances on the European Priority List of Off-Patent Medicinal Products.Paediatric drugs · 2022Article
- Quality of Active versus Spontaneous Reporting of Adverse Drug Reactions in Pediatric Patients: Relevance for Pharmacovigilance and Knowledge in Pediatric Medical Care.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice.Pharmacopsychiatry · 2022Article
- Off-label use of drugs in pediatrics: a scoping review.European journal of pediatrics · 2022Article
- Innovations in Chewable Formulations: The Novelty and Applications of 3D Printing in Drug Product Design.Pharmaceutics · 2022Review
- Pharmacogenomics in Children.Methods in molecular biology (Clifton, N.J.) · 2022Article
- Off-label medication use in pediatrics and associated factors at public hospitals in east Gojjam zone, Ethiopia.SAGE open medicine · 2022Article
- Safety of Off-Label Pharmacological Treatment in Pediatric Neuropsychiatric Disorders: A Global Perspective From an Observational Study at an Italian Third Level Children's Hospital.Frontiers in pharmacology · 2022Article
- Combined Use of Cyclodextrins and Amino Acids for the Development of Cefixime Oral Solutions for Pediatric Use.Pharmaceutics · 2021Article
- Benefit-Risk Assessment of Off-Label Drug Use in Children: The Bravo Framework.Clinical pharmacology and therapeutics · 2021Article
- Model Based Evaluation of Hypersensitivity Adverse Drug Reactions to Antimicrobial Agents in Children.Frontiers in pharmacology · 2021Review
- Postoperative Nausea and Vomiting in Pediatric Patients.Paediatric drugs · 2021Review
- Analysis of Reporting Adverse Drug Reactions in Paediatric Patients in a University Hospital in the Netherlands.Paediatric drugs · 2020Article
- Safety and Biopharmaceutical Challenges of Excipients in Off-Label Pediatric Formulations.International journal of general medicine · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The use of unlicensed and off-label medicines in children is common because trials in children have not usually been performed during the drug development process. Consequently, the information available to paediatricians may not always be as detailed or as robust as that available when prescribing a medicine that is licensed for an approved indication. This has led to concerns that children may be receiving drugs at dosages that either lack efficacy or present safety problems. The latter in particular has received a great deal of attention. In this narrative review, we have evaluated the use of off-label and unlicensed medicines in children and whether and how frequently this predisposes to adverse drug reactions.
Indexed as
Identifiers
21779968What OpenQuestion 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 OpenQuestion graph.