Pediatric drug safety surveillance in Italian pharmacovigilance network: an overview of adverse drug reactions in the years 2001 - 2012.

Objective: To describe the characteristics of pediatric adverse drug reactions (ADRs) reported in Italian spontaneous reporting database.

Methods: Reports of suspected ADRs related to children and adolescents were extracted from 2001 - 2012. After exclusion of duplicates, vaccines and reports containing missing age data, the report characteristics were investigated in terms of implicated drug and adverse drug event across different age-categories.

Results: Among 123,129 selected reports, 8338 (6.8%) concerned pediatrics. Of these, 52.2% involved male patients compared to 47.5% female up to the age of 11. After the age of 11 this statistic reversed. 39.4% of pediatric reports were serious and of these, 75.2% required hospitalization mainly in very young children. Most of reports were issued by hospital physicians (61.9%), followed by pharmacists (10.1%), while reports from family pediatricians accounted for 8.1%. The most frequently implicated drug categories were anti-infectives for systemic use (44.9%), drugs for the nervous system (15.6%), and anti-inflammatory drugs (10.2%). The most frequently suspected compounds differed between children and adults and reports for the same drug were likely to be more serious in adults than in children.

Conclusions: This ADR reporting system reflects real safety concerns for drugs used in children and emphasizes the need for stratifying analyses by age-subgroup to increase the sensitivity of signal detection procedure.