Adverse drug reactions in children reported by means of the yellow card in Spain

Objective: To analyze the case reports concerning children (14 years or younger) in the Spanish Pharmacovigilance System over a 10-year period (1982–1991). Findings: The study of 1419 reports of adverse drug reaction (9.8% of all those received) showed the most commonly involved organs and systems t...

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Bibliographic Details
Published in:Journal of clinical epidemiology 2000-10, Vol.53 (10), p.1076-1080
Main Authors: Morales-Olivas, F.J, Martı́nez-Mir, I, Ferrer, J.M, Rubio, E, Palop, V
Format: Article
Language:English
Subjects:
Adolescent
Adverse Drug Reaction Reporting Systems
Adverse drug reactions
Analysis. Health state
Biological and medical sciences
Child
Child, Preschool
Clinical trial. Drug monitoring
Drug-Related Side Effects and Adverse Reactions
Epidemiology
Female
General aspects
General pharmacology
Humans
Infant
Male
Medical sciences
Pediatric patients
Pharmacoepidemiology
Pharmacology. Drug treatments
Pharmacovigilance
Public health. Hygiene
Public health. Hygiene-occupational medicine
Spain - epidemiology
Spontaneous reporting
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Summary:Objective: To analyze the case reports concerning children (14 years or younger) in the Spanish Pharmacovigilance System over a 10-year period (1982–1991). Findings: The study of 1419 reports of adverse drug reaction (9.8% of all those received) showed the most commonly involved organs and systems to be the skin, digestive tract, and nervous system (62.8%). The most commonly involved pharmacological groups were antibiotics, respiratory medications, and vaccines (69%). The absolute number of reports is higher in children between 1 and 4 years of age (37.9%). There were more reports among males than in females. Less than 5% of the reports notified directly life-threatening or fatal reactions. Conclusions: Adverse drug reaction are not common in pediatric patients, and most are mild. However, due to limitations of clinical trials in children, pharmacoepidemiological studies may be the only source of information on the benefit-risk profile of drugs received by these patients, and as such require special attention.
ISSN:0895-4356
1878-5921
DOI:10.1016/S0895-4356(00)00190-6