{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T14:59:32Z","timestamp":1772809172333,"version":"3.50.1"},"reference-count":48,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2016,9,12]],"date-time":"2016-09-12T00:00:00Z","timestamp":1473638400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2016,12]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>The UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card [YC] Scheme) to collect \u2018suspected\u2019 adverse drug reaction (ADR) data. We aim to describe the content and utility of YC reports received for patients aged &lt;2 years.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Data on all ADRs reported using YC in infants aged &lt;2 years from the years 2001\u201310 were supplied by the MHRA.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>For infants age &lt;2 years, 3496 suspected ADRs were reported using YC (paternal medication pre\u2010conception <jats:italic>n<\/jats:italic>\u00a0=\u00a03, transplacental <jats:italic>n<\/jats:italic>\u00a0=\u00a0246, transmammary <jats:italic>n<\/jats:italic>\u00a0=\u00a030, neonates <jats:italic>n<\/jats:italic>\u00a0=\u00a097, infant <jats:italic>n<\/jats:italic>\u00a0=\u00a0477, and vaccinations <jats:italic>n<\/jats:italic>\u00a0=\u00a02673), 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, <jats:italic>n<\/jats:italic>\u00a0=\u00a021 and <jats:italic>n<\/jats:italic>\u00a0=\u00a04 respectively), neonate (swine flu vaccine, <jats:italic>n<\/jats:italic>\u00a0=\u00a08) infant (oseltamivir, <jats:italic>n<\/jats:italic>\u00a0=\u00a037) and vaccines (meningococcal vaccine, <jats:italic>n<\/jats:italic>\u00a0=\u00a0693). 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The frequency of YC reports for those &lt;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.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.13067","type":"journal-article","created":{"date-parts":[[2016,9,6]],"date-time":"2016-09-06T09:11:12Z","timestamp":1473153072000},"page":"1601-1612","source":"Crossref","is-referenced-by-count":23,"title":["Spontaneous adverse drug reaction reports for neonates and infants in the UK 2001\u20132010: content and utility analysis"],"prefix":"10.1111","volume":"82","author":[{"given":"Daniel B.","family":"Hawcutt","sequence":"first","affiliation":[{"name":"Department of Women's and Children's Health University of Liverpool"},{"name":"NIHR Alder Hey Clinical Research Facility"},{"name":"Alder Hey Children's Hospital  Liverpool"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicki\u2010Jayne","family":"Russell","sequence":"additional","affiliation":[{"name":"Alder Hey Children's Hospital  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