ArticleInternational journal of clinical pharmacy2014
Adverse drug reactions in children reported by European consumers from 2007 to 2011.
Article in International journal of clinical pharmacy, 2014. 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.
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Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The value of patient reporting to the pharmacovigilance system: a systematic review.British journal of clinical pharmacology · 2017Pooled it
- 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
- Analysis of the reporting of adverse drug reactions in children and adolescents in Germany in the time period from 2000 to 2019.PloS one · 2021Article
- Paediatric adverse drug reactions following use of asthma medications in Europe from 2007 to 2011.International journal of clinical pharmacy · 2014Article
- Automatic Identification of Messages Related to Adverse Drug Reactions from Online User Reviews using Feature-based Classification.Iranian journal of public health · 2014Article
- Comparison between paediatric and adult suspected adverse drug reactions reported to the European medicines agency: implications for pharmacovigilance.Paediatric drugs · 2014Article
- A framework for assessing the consistency of drug classes across sources.Journal of biomedical semantics · 2014Article
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInformation about medicines safety in children is very limited. Consumer adverse drug reaction (ADR) reports can provide information about serious and unknown ADRs from medicine use in children.
objectiveTo characterize ADRs in children reported by consumers in Europe from 2007 to 2011.
methodsWe analysed ADRs reported to the European ADR database, EudraVigilance (EV) for individuals from birth to 17 years. Data were characterized with respect to age and sex of the child, type of ADR (system organ class and preferred term), seriousness and suspected medicines (anatomical therapeutic chemical classification system level 1 and 5).
resultsIn total, 240 ADR reports corresponding to 670 ADRs were identified. The relatively largest share of ADRs were reported for infants below 1 year followed by teenagers, and 60 % of all ADRs were reported for girls. The majority of ADRs reported were of the general type (20 %) and nervous system disorders (15 %). The largest share of serious ADRs was of the type nervous system disorders (17 % of all serious). Three cases of death were reported. Vaccines and anti-infectives for systemic use contributed to 30 % of ADRs, antineoplastic and immunomodulating agents for 23 % and sex hormones for 13 %.
conclusionOnly few paediatric ADR consumer reports were found in EudraVigilance. Many of these ADRs were serious, and fatal cases were reported, however also nonserious reports were present. The findings indicate that consumer reports may be of value in paediatric ADR signal detection.
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Registered trials
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