TY - JOUR
T1 - Adverse drug reactions in Ghanaian children
T2 - Review of reports from 2000 to 2012 in VigiBase
AU - Cliff-Eribo, Kennedy Obebi
AU - Choonara, Imti
AU - Dodoo, Alex
AU - Darko, Delese M.
AU - Sammons, Helen
N1 - Publisher Copyright:
© 2015 Taylor & Francis.
PY - 2015/12/2
Y1 - 2015/12/2
N2 - Objective: The aim of this article is to describe adverse drug reactions (ADRs) reported for children aged 0-17 years in Ghana.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.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.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.
AB - Objective: The aim of this article is to describe adverse drug reactions (ADRs) reported for children aged 0-17 years in Ghana.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.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.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.
KW - adverse drug reactions
KW - children
KW - drug safety
KW - pharmacovigilance
KW - spontaneous reporting system
UR - http://www.scopus.com/inward/record.url?scp=84951908330&partnerID=8YFLogxK
U2 - 10.1517/14740338.2015.1096927
DO - 10.1517/14740338.2015.1096927
M3 - Review article
C2 - 26436964
AN - SCOPUS:84951908330
SN - 1474-0338
VL - 14
SP - 1827
EP - 1833
JO - Expert Opinion on Drug Safety
JF - Expert Opinion on Drug Safety
IS - 12
ER -