RT Journal Article
SR Electronic
T1 Adverse drug reactions in children in Camagüey Province, Cuba
JF Archives of Disease in Childhood
JO Arch Dis Child
FD BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health
SP 474
OP 477
DO 10.1136/adc.2009.180786
VO 95
IS 6
A1 Z Bárzaga Arencibia
A1 D Novoa Sotomayor
A1 N Caballero Mollinedo
A1 I Choonara
A1 E Fernández Manzano
A1 A López Leyva
YR 2010
UL http://adc.bmj.com/content/95/6/474.abstract
AB Objective To determine the incidence of adverse drug reactions (ADRs) in children in Camagüey Province, Cuba. Methods A national pharmacovigilance programme has been established in Cuba and involves suspected ADRs being reported to provinces. All suspected ADRs reported to Camagüey Province during 2008 were analysed and classified in relation to causality and severity. Results Over a 12-month period, there were 124 reports of 152 suspected ADRs in children. Most ADRs were mild (98, 79%), but two were fatal and five others were severe. Antibiotics were the group of medicines most likely to be associated with ADRs. The overall report rate of suspected ADRs was 634 per million children per year, which is considerably higher than previously reported rates. Conclusions ADRs in children are more frequent than previously reported. A successful pharmacovigilance programme can be established in lower middle income countries.