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. 2011 May;71(5):751-7.
doi: 10.1111/j.1365-2125.2011.03915.x.

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

Lise Aagaard  1 , Ebba Holme Hansen
Affiliations

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

Lise Aagaard et al. Br J Clin Pharmacol. 2011 May.

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.

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