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Adverse drug reactions and off-label and unlicensed medicines in children: a prospective cohort study of unplanned admissions to a paediatric hospital
Open accessAbstract
AIMS: To examine the impact of off-label and unlicensed (OLUL) prescribing on adverse drug reactions (ADRs) causing unplanned admissions to a paediatric hospital. METHODS: Prescription data from a 12 month prospective cohort study of ADRs detected in children admitted to a paediatric hospital were scrutinized. The relative risk for off-label and unlicensed medicines being implicated in an ADR was calculated. Logistic regression analyses were carried out with exposure to off-label and unlicensed medicines and number of off-label and unlicensed medicines administered as predictor variables. RESULTS: Off-label and unlicensed medicines were more likely to be implicated in an ADR than authorized medicines (relative risk 1.67, 95% CI 1.38, 2.02, P < 0.001). There was a 25% increase in ADR risk (95% CI 1.16, 1.35, P < 0.001) with each additional authorized medicine and 23% (95% CI 1.10, 1.36, P < 0.001) with each additional off-label or unlicensed medicine. Logistic regression analysis focusing on non-oncology patients demonstrated that the number of authorized medicines (odds ratio 1.33, 95% CI 1.23, 1.44, P < 0.001), but not the number of off-label and unlicensed medicine courses, was a predictor of ADR risk. CONCLUSIONS: In a heterogeneous population of children admitted to a secondary/tertiary hospital, off-label and unlicensed medicines are more likely to be implicated in an ADR than authorized medicines. This was largely driven by ADRs related to drugs used in oncological practice, where the usage of off-label or unlicensed medicines was associated with a higher ADR risk than in non-oncological areas.
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Transplanting adult evidence into children can yield sub-therapeutic dosing, diminished efficacy, or an elevated risk of adverse reactions.
“transplanting adult evidence into children can yield sub-therapeutic dosing, diminished efficacy, or an elevated risk of adverse reactions [2-4].”
From PED-X-Bench: A Benchmark of Adult-to-Pediatric Extrapolation Decisions in FDA Drug Labels (2025) · cites this paper as [4]
The Discussion (page unavailable in our copy) reports an elevated ADR risk associated with off-label or unlicensed medicines in the full cohort, largely driven by oncology patients, and says dosage is important to efficacy and safety. It does not link those outcomes to transplanting adult evidence into children or report sub-therapeutic dosing or diminished efficacy. (LLM, conf=0.84)
Experimental — accuracy not yet measuredGrowth and maturation reshape both pharmacokinetics and disease biology.
“Because growth and maturation reshape both pharmacokinetics and disease biology”
From PED-X-Bench: A Benchmark of Adult-to-Pediatric Extrapolation Decisions in FDA Drug Labels (2025) · cites this paper as [4]
The Results report an association between age and adverse drug reaction risk, while the Discussion focuses on prescribing and dosage. Neither passage says that growth or maturation reshapes pharmacokinetics or disease biology; searches for those concepts found no supporting passage in our copy. (LLM, conf=0.76)
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What are the considerations when initiating treatment for epilepsy in children?
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Solving the problem of dose optimization of children’s medicines
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Off-label Prescribing Practice in Pediatric Settings: Pros and Cons
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Drug Safety in Children: Focus on hepatic concerns
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Unregistered and off-label medicine use in highly specialised paediatrics at Tygerberg Hospital
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Suspected Serious Adverse Drug Reactions in Hospitalized COVID-19 PatientsPreprint
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ADRs and Children: Knowledge and Methodological Standard in PASS (Post Authorization Safety Studies)
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Unlicensed medicine prescribing in general practice
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A narrative review on adverse drug reactions of COVID-19 treatments on the kidney
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Analysis of adverse drug reactions reported in a tertiary care children hospital
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PED-X-Bench: A Benchmark of Adult-to-Pediatric Extrapolation Decisions in FDA Drug Labels
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“Because growth and maturation reshape both pharmacokinetics and disease biology, transplanting adult evidence into children can yield sub-therapeutic dosing, diminished efficacy, or an elevated risk of adverse reactions [2–4].”
Clinical Pharmacology and the Individualized Approach to Treatment
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Clinical analysis and study of 844 children with adverse drug reactions in China
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Kindvriendelijke geneesmiddelen
van Riet‐Nales, D. A., Schobben, F., Vromans, H., Egberts, T. C. G., & Rademaker, C. M. A. (2017) · Huisarts en Wetenschap · doi:10.1007/s12445-017-0011-1
Anwendungspraktische Limitationen bei der Aufklärung im Rahmen von Arzneimitteltherapien
Meyer, T., & Steuer, M. (2021) · Medizinische Klinik - Intensivmedizin und Notfallmedizin · doi:10.1007/s00063-021-00856-7
Dinte, E., MATEI, D., & Zehan, T. (2021) · Romanian Journal of Pharmaceutical Practice · doi:10.37897/rjphp.2021.2.6
(2021) · International Journal of Biology Pharmacy and Allied Sciences · doi:10.31032/ijbpas/2021/10.9.1045
Off-label drug use in children increases risk of ADRs
(2013) · Reactions Weekly · doi:10.1007/s40278-013-5443-1
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Metadata
- Authors
- Bellis, J. R., Kirkham, J. J., Nunn, A. J., & Pirmohamed, M.
- Affiliations
- Alder Hey Children's NHS Foundation Trust (GB)
- University of Liverpool (GB)
- Corresponding author
- Bellis, Jennifer R.
- Venue
- British Journal of Clinical Pharmacology
- Publisher
- Wiley
- Published
- 2014-02-21
- Volume
- 77
- Issue
- 3
- Pages
- 545-553
- ISSN
- 0306-5251 (ISSN-L)
- PMC
- PMC4371534
- OpenAlex
- W1484081358
- Cited by
- 120
- References
- 17
- Citations by year
- 2026: 6 · 2025: 3 · 2024: 18 · 2023: 8 · 2022: 13 · 2021: 12 · 2020: 9 · 2019: 7 · 2018: 10 · 2017: 8 · 2016: 8 · 2015: 6 · 2014: 11
- FWCI
- 7.99
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- British Journal of Clinical Pharmacology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (publishedVersion)
- Funders
- National Institute for Health and Care Research (NF-SI-0512-10064)
- Medical Research Council (MR/L006758/1)
- Topics
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Geriatrics and Gerontology › Pharmaceutical Practices and Patient Outcomes
- Keywords
- adverse drug reactions, off-label drug use, unlicensed medicines, pediatric hospital admissions, emergency admissions, children, oncology drugs, drug safety, polypharmacy
- MeSH terms
- Adolescent, Child, Child, Preschool, England, Female, Hospitals, Pediatric, Humans, Infant, Infant, Newborn, Male, Patient Admission, Prospective Studies, Risk Factors, Time Factors, Chi-Square Distribution, Logistic Models, Odds Ratio, Polypharmacy, Off-Label Use, Tertiary Care Centers, Drug-Related Side Effects and Adverse Reactions
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