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.