Adverse Drug Reactions in the Paediatric Population in Denmark: A Retrospective Analysis of Reports Made to the Danish Medicines Agency from 1998 to 2007
Abstract
Background The potential risk of adverse drug reactions (ADRs) in the paediatric population has become a public health concern and regulatory agencies in Europe and the US have acknowledged that there is a need for more research in this area. Spontaneous reporting systems can provide important new information about ADRs.Objective To characterize ADRs in children reported in Denmark over a period of one decade.Methods We analysed ADRs reported to the Danish Medicines Agency from 1998 to 2007 for individuals aged from birth to 17 years. Data were analysed with respect to time, age and sex, category of ADR (System Organ Class [SOC]), seriousness, suspected medicines (level 2 of the Anatomical Therapeutic Chemical [ATC] Classification System) and type of reporter.Results 2437 ADR reports corresponding to 4500 ADRs were analysed. On average, 234 ADR reports were submitted annually, corresponding to approximately two ADRs per report. From 2003 to 2005, an increasing number of ADRs submitted per report were observed, but after 2005 the reporting rate decreased. One-half of ADRs were reported for infants from birth to 2 years of age. Similar total numbers of ADRs were reported for boys and girls. The majority of ADRs reported were from the following SOCs: general disorders and administration site conditions (31%), skin and subcutaneous tissue disorders (18%) and nervous system disorders (15%). Reports encompassed medicines from ATC group J: vaccines and anti-infectives for systemic use (65%); and ATC group N: nervous system (17%). On average, 42% of ADRs were classified as serious. ATC group N had the highest proportion of ADRs that were classified as serious. Although physicians reported approximately 90% of the ADRs, a relatively large proportion of serious ADRs were reported by other sources.Conclusion In Denmark, the ADR reporting rate in the paediatric population has declined since 2005. The majority of ADRs reported in young children were reported for vaccines and anti-infectives, but also a high number of serious ADRs were reported for medicines from ATC group N. The Danish Medicines Agency should monitor prescribing patterns more tightly to identify potential risks in the paediatric population in relation to the evolving pattern of medicine use among children.
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In Denmark between 1998 and 2007, spontaneous reports of adverse drug reactions classed as serious were reported in 52 children taking methylphenidate and 18 children taking atomoxetine.
“of all spontaneous reports of adverse drug reactions in Denmark between 1998 and 2007, drug reactions were classed as ‘serious’ when reported in 52 and 18 children taking methylphenidate and atomoxetine, respectively [5].”
From European guidelines on managing adverse effects of medication for ADHD (2011) · cites this paper as [5]
The assessment of sudden deaths with relation to patient-years of treatment described atomoxetine deaths at 0.5 per 100,000 patient-years, and methylphenidate at 0.2 per 100,000 patient-years.
“The assessment of sudden deaths with relation to patient-years of treatment described atomoxetine deaths at 0.5 per 100,000 patient-years, and methylphenidate at 0.2 per 100,000 patient-years [5].”
From European guidelines on managing adverse effects of medication for ADHD (2011) · cites this paper as [5]
The analysis of 10-year adverse-event reporting in Denmark resulted in no sudden deaths in children taking ADHD medications.
“The analysis of 10-year adverse-event reporting in Denmark resulted in no sudden deaths in children taking ADHD medications [5].”
From European guidelines on managing adverse effects of medication for ADHD (2011) · cites this paper as [5]
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European guidelines on managing adverse effects of medication for ADHD
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- Authors
- Aagaard, L., Weber, C. B., & Hansen, E. H.
- Affiliations
- University of Copenhagen (DK)
- Corresponding author
- Aagaard, Lise
- Venue
- Drug Safety
- Published
- 2010-04
- Volume
- 33
- Issue
- 4
- Pages
- 327-339
- ISSN
- 0114-5916 (ISSN-L)
- OpenAlex
- W1968133930
- Cited by
- 75
- References
- 25
- Citations by year
- 2026: 1 · 2025: 1 · 2022: 3 · 2021: 7 · 2020: 3 · 2019: 2 · 2018: 3 · 2017: 2 · 2016: 11 · 2015: 5 · 2014: 9 · 2013: 3 · 2012: 11
- FWCI
- 11.96
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Drug Safety (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Health Sciences › Health Professions › Emergency Medical Services › Patient Safety and Medication Errors
- Keywords
- adverse drug reactions, drug safety in children, spontaneous reporting, pharmacovigilance, infants, vaccines, anti-infective agents, neurological disorders, serious adverse events, prescribing patterns
- MeSH terms
- Adolescent, Age Factors, Child, Child, Preschool, Denmark, Female, Humans, Infant, Infant, Newborn, Male, Practice Patterns, Physicians', Sex Factors, Adverse Drug Reaction Reporting Systems, Drug-Related Side Effects and Adverse Reactions
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