ArticleBritish journal of clinical pharmacology2011
Prescribing of medicines in the Danish paediatric population outwith the licensed age group: characteristics of adverse drug reactions.
Article in British journal of clinical pharmacology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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Who cites it
14 citing papers in PubMed, 38 citations in OpenAlex.
- Off-label drug use in children and adolescents treated with antidepressants and antipsychotics: results from a prospective multicenter trial.Child and adolescent psychiatry and mental health · 2025Article
- Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice.Pharmacopsychiatry · 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
- Suspected Adverse Drug Reactions in Pediatric Cancer Patients in China: An Analysis of Henan Province Spontaneous Reporting System Database.Frontiers in oncology · 2021Article
- Safety of Anticancer Agents Used in Children: A Focus on Their Off-Label Use Through Data From the Spontaneous Reporting System.Frontiers in pharmacology · 2020Article
- Two decades of off-label prescribing in children: a literature review.World journal of pediatrics : WJP · 2018Review
- Reported Adverse Drug Reactions in Infants: A Nationwide Analysis in Malaysia.Frontiers in pharmacology · 2017Article
- Multidisciplinary approach to improve spontaneous ADR reporting in the pediatric outpatient setting: a single-institute experience in Korea.SpringerPlus · 2016Article
- Off-label prescribing for allergic diseases in children.The World Allergy Organization journal · 2014Article
- Drug utilization pattern in an Omani pediatric population.Journal of basic and clinical pharmacy · 2013Article
- Evaluation of attitudes towards treatment in adolescents with attention deficit hyperactivity disorder (ADHD).European child & adolescent psychiatry · 2012Article
- Off-label and unlicensed medicine use and adverse drug reactions in children: a narrative review of the literature.European journal of clinical pharmacology · 2012Review
- Off-Label Prescribing of Antipsychotics in a Danish Child and Adolescent Mental Health Center: A Register-Based Study.Journal of research in pharmacy practiceArticle
- [Challenges on off label medicine use].Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao PauloArticle
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Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo identify adverse drug reactions (ADRs) associated with off-label prescribing of medicines in a paediatric population.
methodsWe analysed spontaneous ADR reports for children from ages 0 to 17 years submitted to the Danish national ADR database from 1998 to 2007. We defined off-label prescribing as prescriptions outside the licensed age group. Off-label ADRs were categorized by therapeutic group, age of child, type and severity. The unit of analysis was one ADR.
resultsWe analysed 4388 ADRs for children reported in the national database. Approximately 17% of reported ADRs were associated with off-label use, 60% of them serious. More than one half of off-label ADRs were reported in adolescents. Serious ADRs due to off-label prescribing are more likely to be reported for hormonal contraceptives (ATC group G), anti-acne preparations (ATC group D) and allergens (ATC group V).
conclusionOne-fifth of all ADRs reported over a decade in Danish children was associated with off-label prescribing, and serious ADRs due to off-label prescribing were primarily present in three therapeutic groups: sex hormones, dermatologicals and allergens. There is a need for more research into the prescribing of these medicines in the teenage population, as well as tighter reporting and monitoring of ADRs for medicines prescribed off-label in the paediatric population.
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