Prescribing of medicines in the Danish paediatric population outwith the licensed age group: characteristics of adverse drug reactions.

摘要: WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Off-label use of medicine in children is common, as few medications are licensed for this population. • There concern about off-label medicines due to lack knowledge safety beyond the indication area described official product information documented licensing material. WHAT STUDY ADDS • One-fifth all ADRs reported over a decade Danish were associated with prescribing medicines. • Serious from primarily appeared therapeutic groups: allergens, dermatologicals and sex hormones. • Until more clinical studies conducted children, prescribers carers must be aware risk potentially serious prescribing, paediatric population should closely monitored. AIM To identify adverse drug reactions (ADRs) population. METHODS We analysed spontaneous ADR reports ages 0 17 years submitted national database 1998 2007. defined prescriptions outside age group. Off-label categorized by group, child, type severity. The unit analysis was one ADR. RESULTS 4388 database. Approximately 17% use, 60% them serious. More than half adolescents. Serious likely hormonal contraceptives (ATC group G), anti-acne preparations D) allergens V). CONCLUSION One-fifth present three hormones, allergens. There need research into these teenage population, well tighter reporting monitoring prescribed population.