Adverse drug reactions and off-label drug use in paediatric outpatients.
OBJECTIVE
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.
Horen
Benjamin
B
Laboratoire de Pharmacologie Médicale et Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et dInformations sur le médicament, Faculté de Médecine.
Montastruc
Jean-Louis
JL
Lapeyre-Mestre
Maryse
M
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D004348:Drug Labeling; D011307:Drug Prescriptions; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005602:France; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D010045:Outpatients; D010372:Pediatrics / Q000379:methods*; D011446:Prospective Studies