Adverse drug reactions in children in Camagüey Province, Cuba.
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.
Arencibia
Z Bárzaga
ZB
Department of Pharmacoepidemiology, Camaguey Children's Hospital, Camagüey Province, Cuba.
Sotomayor
D Novoa
DN
Mollinedo
N Caballero
NC
Choonara
I
I
Manzano
E Fernández
EF
Leyva
A López
AL
D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D017677:Age Distribution; D000900:Anti-Bacterial Agents / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D003462:Cuba / Q000453:epidemiology; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D014612:Vaccines / Q000009:adverse effects
D000900:Anti-Bacterial Agents; D014612:Vaccines