Adverse drug reactions in children: a ten-year review of reporting to the Portuguese Pharmacovigilance System

Abstract

Objective: Adverse drug reactions (ADR) are a public health problem. They cause significant morbidity, mortality and health costs. Less is known about pediatric ADR. Our goal was to characterize a pediatric case series of ADR reported to the Portuguese Pharmacovigilance System (PPS) during the past 10 years.

Research design and methods: Retrospective analysis of ADR reports concerning patients till 17 years old received by the PPS between 2003 and 2012. We evaluated patients’ demographic data and involved drugs, as well as characteristics and seriousness of reactions, stratified by age groups.

Results: We found 1742 reports (50% females) corresponding to 9.7% of the total received. The age of the patients varied from 0 to 17 years (median: 5 years, interquartile range: 10.6), with 566 cases (32%) occurring in patients younger than 2y. Among the 1195 serious cases, 31% (370) episodes led to hospitalization. In 32 cases (2%) there was a fatal outcome. Most of the ADR reported referred to general disorders and administration site conditions, followed by skin and subcutaneous tissue reactions. Vaccines were the most represented group (42%) followed by antibacterials for systemic use (17%).

Conclusions: Pediatric ADR represents about 10% of the reports received by the PPS. Most ADR were considered serious. Major findings varied according to age groups.

Keywords:

• adverse drug reactions
• pediatric
• pharmacovigilance

Acknowledgments

This study is a retrospective analysis of data received by the Portuguese Pharmacovigilance System and as data are anonymous an ethical committee approval was not needed. Data included in this article has not been presented before.