Adverse drug reactions in Ghanaian children: review of reports from 2000 to 2012 in VigiBase

Article English OPEN
Cliff-Eribo, Kennedy Obebi ; Choonara, Imti ; Dodoo, Alex ; Darko, Delese M. ; Sammons, Helen (2015)

Objective: The aim of this article is to describe adverse drug reactions (ADRs) reported for children aged 0 - 17 years in Ghana.\ud Methods: Paediatric reports submitted by the Ghana National Centre for Pharmacovigilance to the World Health Organisation (WHO) Global ADR database, VigiBase up to December 2012 were extracted. The data were analysed for number of reports per year, types of reporters and suspected ADRs and drugs.\ud Results: A total of 343 reports for children were received during the period. The drug classes most frequently reported were vaccines (115, 31%), antimalarials (106, 28%) and antibiotics (57, 15%). Of the top 20 individual drugs, 19 were anti-infectives. The most frequently reported ADRs were injection site infection, fever and rash. There were 23 deaths reported, and antimalarials were implicated in 12 cases.\ud Conclusions: Vaccines, antimalarials and antibiotics are the leading medicines reported to cause ADRs in Ghanaian children. There was a high mortality rate, with many of the deaths due to causes explained in the individual case safety reports.
  • References (13)
    13 references, page 1 of 2

    Pirmohamed, M., et al., Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ, 2004. 329(7456): p. 15-9.

    Drug Saf, 2006. 29(5): p. 385-96.

    Aagaard, L., A. Christensen, and E.H. Hansen, Information about adverse drug reactions reported in children: a qualitative review of empirical studies. Br J Clin Pharmacol, 2010.

    70(4): p. 481-91.

    Clavenna, A. and M. Bonati, Adverse drug reactions in childhood: a review of prospective studies and safety alerts. Arch Dis Child, 2009. 94(9): p. 724-8.

    European Journal of Clinical Pharmacology, 2012. 68(7): p. 1079-1084.

    Aagaard, L., C.B. Weber, and E.H. Hansen, Adverse drug reactions in the paediatric population in Denmark: a retrospective analysis of reports made to the Danish Medicines Agency from 1998 to 2007. Drug Saf, 2010. 33(4): p. 327-39.

    This study is useful for comparison of paediatric ADRs across countries Venulet, J. and M. Helling-Borda, WHO's International Drug Monitoring - The Formative Years, 1968-1975. Preparatory, Pilot and Early Operational Phases. Drug Saf, 2010. 33(7): p. e1-e23.

    Star, K., et al., Suspected adverse drug reactions reported for children worldwide: an exploratory study using VigiBase. Drug Saf, 2011. 34(5): p. 415-28.

    This study is useful for comparison of paediatric ADRs across countries Aldea, A., et al., Paediatric adverse drug reactions reported to the Spanish Pharmacovigilance System from 2004 to 2009. Eur J Clin Pharmacol, Sep;68(9):1329-38., 2012.

  • Metrics
    No metrics available
Share - Bookmark