Suspected Adverse Drug Reactions Reported For Children Worldwide: An Exploratory Study Using VigiBase

Background: As a first step towards implementing routine screening of safety issues specifically related to children at the Uppsala Monitoring Centre, this study was performed to explore reporting patterns of adverse reactions in children. Objective: The first aim of this study was to characterize and contrast child reports against adult reports in an overall drug and adverse reaction review. The second aim was to highlight increases in reporting of specific adverse reactions during recent years subdivided by age group. Study Design: This was an exploratory study of internationally compiled individual case safety reports (ICSRs). Setting: Reports were extracted from the WHO global ICSR database, VigiBase, up until 5 February 2010. The reports in VigiBase originate from 97 countries and the likelihood that a medicine caused the adverse effect may vary from case to case. Suspected duplicate and vaccine reports were excluded from the analysis, as were reports with age not specified. The Medical Dictionary for Regulatory Activities (MedDRA®) and the WHO Anatomical Therapeutic Chemical (ATC) classification were used to group adverse reactions and drugs. Patients: In the general review, reports from 1968 to 5 February 2010 were divided into child (aged 0–17 years) and adult (≥18 years) age groups. To highlight increases in reporting rates of specific adverse reactions during recent years, reports from 2005 to February 2010 were compared with reports from 1995 to 1999. The ten adverse reactions with the greatest difference in the proportion of reports between the two time periods were reviewed. In the latter analysis, the reports were subdivided into age groups: neonates ≤27 days; infants 28 days–23 months; children 2–11 years; and adolescents 12–17 years. Results: A total of 3 472 183 reports were included in the study, of which 7.7% (268 145) were reports for children (0–17 years). Fifty-three percent of the child reports were for males, whilst 39% of reports in the adult group were for males. The proportion of reports involving children among Asian reports was 14% and was 15% among reports from Africa and Latin America, including the Caribbean. Among reports from North America, Oceania and Europe, 7% of the reports involved children. For the ATC drug classification groups, the largest difference in percentage units between the child and adult groups was seen for the anti-infective (33 vs 15%), respiratory (11 vs 5%) and dermatological (12 vs 7%) drug groups. S