Abstract
AIM: To identify adverse drug reactions (ADRs) associated with off-label prescribing of medicines in a paediatric population.
METHODS: We analysed spontaneous ADR reports for children from ages 0 to 17 years submitted to the Danish national ADR database from 1998 to 2007. We defined off-label prescribing as prescriptions outside the licensed age group. Off-label ADRs were categorized by therapeutic group, age of child, type and severity. The unit of analysis was one ADR.
RESULTS: We analysed 4388 ADRs for children reported in the national database. Approximately 17% of reported ADRs were associated with off-label use, 60% of them serious. More than one half of off-label ADRs were reported in adolescents. Serious ADRs due to off-label prescribing are more likely to be reported for hormonal contraceptives (ATC group G), anti-acne preparations (ATC group D) and allergens (ATC group V).
CONCLUSION: One-fifth of all ADRs reported over a decade in Danish children was associated with off-label prescribing, and serious ADRs due to off-label prescribing were primarily present in three therapeutic groups: sex hormones, dermatologicals and allergens. There is a need for more research into the prescribing of these medicines in the teenage population, as well as tighter reporting and monitoring of ADRs for medicines prescribed off-label in the paediatric population.
| Original language | English |
|---|---|
| Journal | British Journal of Clinical Pharmacology |
| Volume | 71 |
| Issue number | 5 |
| Pages (from-to) | 751-7 |
| Number of pages | 7 |
| ISSN | 0306-5251 |
| DOIs | |
| Publication status | Published - May 2011 |
Keywords
- Adolescent
- Adverse Drug Reaction Reporting Systems
- Age Distribution
- Child
- Child, Preschool
- Denmark
- Drug Prescriptions
- Drug-Related Side Effects and Adverse Reactions
- Female
- Humans
- Infant
- Infant, Newborn
- Male
- Off-Label Use
- Retrospective Studies
- Severity of Illness Index
- Young Adult