ArticleBritish journal of clinical pharmacology2016
Spontaneous adverse drug reaction reports for neonates and infants in the UK 2001-2010: content and utility analysis.
Article in British journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
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Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.
- Reconsidering clinical pharmacology frameworks as a necessary strategy for improving the health care of patients: a systematic review.European journal of clinical pharmacology · 2018Pooled it
- EudraVigilance insights: Suspected adverse drug reactions in infants through breastfeeding.British journal of clinical pharmacology · 2025Observational
- LEVERAGING UNSTRUCTURED DATA IN ELECTRONIC HEALTH RECORDS TO DETECT ADVERSE EVENTS FROM PEDIATRIC DRUG USE - A SCOPING REVIEW.medRxiv : the preprint server for health sciences · 2025Article
- Clinical lactation studies. Acting on key recommendations over the last decade.npj women's health · 2025Review
- The Value of Social Media Analysis for Adverse Events Detection and Pharmacovigilance: Scoping Review.JMIR public health and surveillance · 2024Article
- Adverse drug reactions in neonates: a brief analysis of the FDA adverse event reporting system.Frontiers in pharmacology · 2024Article
- The Role of Social Media for Identifying Adverse Drug Events Data in Pharmacovigilance: Protocol for a Scoping Review.JMIR research protocols · 2023Article
- Implementing a specialist paediatric clinical pharmacology service in a UK children's hospital.British journal of clinical pharmacology · 2022Article
- Efficacy, Retention and Tolerability of Everolimus in Patients with Tuberous Sclerosis Complex: A Survey-Based Study on Patients' Perspectives.CNS drugs · 2021Article
- Prospective identification and causality evaluation of suspected adverse drug reactions in neonates.British journal of clinical pharmacology · 2021Observational
- Adverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event Reporting Systems.Therapeutics and clinical risk management · 2021Article
- Characteristics of Adverse Events Following Immunization Reporting in Children: The Japanese Adverse Drug Event Report Database.Vaccines · 2020Article
- Characteristics of pediatric adverse drug reaction reports in the Japanese Adverse Drug Event Report Database.BMC pharmacology & toxicology · 2020Article
- Spontaneous adverse drug reaction reports on patients with cirrhosis: analysis of the nature, quantity and quality of the reports.European journal of clinical pharmacology · 2020Article
- Spontaneous adverse drug reaction reports for neonates and infants in the UK 2001-2010: content and utility analysis.British journal of clinical pharmacology · 2016Article
Corrections and comments
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Authors and funding
9 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThe UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card [YC] Scheme) to collect 'suspected' adverse drug reaction (ADR) data. We aim to describe the content and utility of YC reports received for patients aged <2 years.
methodsData on all ADRs reported using YC in infants aged <2 years from the years 2001-10 were supplied by the MHRA.
resultsFor infants age <2 years, 3496 suspected ADRs were reported using YC (paternal medication pre-conception n = 3, transplacental n = 246, transmammary n = 30, neonates n = 97, infant n = 477, and vaccinations n = 2673), averaging 0.96 YC per day. There was a male preponderance (male 49.1%, female 44.4%, unknown 6.5%), and only 34 (1.0%) of YC reports stated a gestational age. The medications most frequently reported were: transplacental and transmammary (fluoxetine, n = 21 and n = 4 respectively), neonate (swine flu vaccine, n = 8) infant (oseltamivir, n = 37) and vaccines (meningococcal vaccine, n = 693). Paternal, transmammary, neonatal and infant YC did not reflect clinical concerns raised by the UK regulator. Transplacental and vaccination reports did correlate with some of the changes in practice and clinical alerts received.
conclusionsThe frequency of YC reports for those <2 years is low, neonates are poorly represented, and recording of gestational age is poor. With the exception of vaccinations, spontaneous reports alone are not currently generating the data required, and important safety messages from the regulator do not match reporting patterns. Additional reporting strategies are required to improve the quantity and quality of suspected ADR data in young children.
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