Adverse drug reactions and off-label drug use in paediatric outpatients

Br J Clin Pharmacol. 2002 Dec;54(6):665-70. doi: 10.1046/j.1365-2125.2002.t01-3-01689.x.


Aims: To investigate the potential relationship between off-label drug use and increased risk of adverse drug reactions in paediatric outpatients.

Methods: A prospective pharmacovigilance survey of drug prescribing in office based paediatricians was carried out in Haute-Garonne County (south west of France).

Results: The study involved a sample of 1419 children under 16 years old. Forty-two percent of patients were exposed to at least one off-label prescription. The incidence of adverse drug reactions was 1.41% (95% CI 0.79, 2.11). Off-label drug use was significantly associated with adverse drug reactions (relative risk 3.44; 95% CI 1.26, 9.38), particularly when it was due to an indication different than that defined in the Summary Product Characteristics (relative risk 4.42; 95% CI 1.60, 12.25).

Conclusions: Our data suggest an increasing risk of adverse drug reactions related to off-label drug use. This risk would be acceptable if further studies prove the potential benefit of such a drug use.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Child
  • Child, Preschool
  • Drug Labeling*
  • Drug Prescriptions*
  • Drug-Related Side Effects and Adverse Reactions*
  • Female
  • France
  • Humans
  • Infant
  • Infant, Newborn
  • Male
  • Outpatients*
  • Pediatrics / methods*
  • Prospective Studies