Adverse drug reactions in paediatric patients. A pharmacovigilance investigation in Sicily

The aim of the present study was to investigate the spontaneous reports of suspected adverse drug reactions, observed in paediatric patients in Sicily during the period between the 1st January 1995 and the 31st August 1997. The ADRs were classified according to the "WHO Programme for International Monitoring of Adverse Reactions to Drugs". On 1020 reports, the paediatric suspected ADRs were 130 (12.7%); 23% of these was serious, and 29.2% involved children aged 3 years or less. The antimicrobial and the musculoskeletal drugs were responsible of 74.6% of the whole suspected paediatric ADRs. Cutaneous and gastrointestinal apparatus were involved in 70% of reports and were the most frequently targets of ADRs. On 57 different molecules ceftriaxone and co-amoxiclav were the most common drugs causing ADRs with a percentage of 13%. In 45.4% of ADRs the suspension of the treatment occurred, in 34.6% therapy was needed besides the suspension of the drug, whilst in 11.5% patients needed an hospital visit. In 59.2% spontaneous reports were sent by hospitals, in 32.3% by primary health care and the remaining percentage by other sources. Our investigation should stimulate physicians to better evaluate the potential side effects of drugs and the cost/effectiveness profile of paediatric therapies