Spontaneous adverse drug reaction reports for neonates and infants in the UK 2001-2010: content and utility analysis.
The 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.



Data on all ADRs reported using YC in infants aged <2 years from the years 2001-10 were supplied by the MHRA.



For 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.



The 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.
Department of Women's and Children's Health, University of Liverpool.|NIHR Alder Hey Clinical Research Facility.|Alder Hey Children's Hospital, Liverpool.
Daniel B
DB
Hawcutt
Alder Hey Children's Hospital, Liverpool.
Nicki-Jayne
NJ
Russell
Alder Hey Children's Hospital, Liverpool.
Hannah
H
Maqsood
Medical Student, University of Liverpool.
Koushan
K
Kouranloo
Alder Hey Children's Hospital, Liverpool.
Simon
S
Gomberg
Department of Molecular and Clinical Pharmacology, University of Liverpool.
Catriona
C
Waitt
Department of Women's and Children's Health, University of Liverpool.|Liverpool Women's NHS Foundation Trust, Liverpool.
Andrew
A
Sharp
Alder Hey Children's Hospital, Liverpool.
Andrew
A
Riordan
Department of Women's and Children's Health, University of Liverpool.|Liverpool Women's NHS Foundation Trust, Liverpool.
Mark A
MA
Turner
D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000209:etiology; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D018811:Maternal Exposure / Q000706:statistics & numerical data; D018812:Paternal Exposure / Q000706:statistics & numerical data; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D011247:Pregnancy; D011297:Prenatal Exposure Delayed Effects / Q000453:epidemiology / Q000209:etiology; D006113:United Kingdom / Q000453:epidemiology; D014611:Vaccination / Q000009:adverse effects
D004364:Pharmaceutical Preparations
adverse drug reaction; fetal; neonate; paediatric; pharmacology; spontaneous reporting scheme