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

To investigate the potential relationship between off-label drug use and increased risk of adverse drug reactions in paediatric outpatients. A prospective pharmacovigilance survey of drug prescribing in office based paediatricians was carried out in Haute-Garonne County (south west of France). The s...

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Bibliographic Details
Published in:British journal of clinical pharmacology 2002-12, Vol.54 (6), p.665-670
Main Authors: HOREN, Benjamin, MONTASTRUC, Jean-Louis, LAPEYRE-MESTRE, Maryse
Format: Article
Language:English
Subjects:
Adolescent
Biological and medical sciences
Child
Child, Preschool
Drug Labeling
Drug Prescriptions
Drug toxicity and drugs side effects treatment
Drug-Related Side Effects and Adverse Reactions
Female
France
Humans
Infant
Infant, Newborn
Male
Medical sciences
Miscellaneous (drug allergy, mutagens, teratogens...)
Outpatients
Pediatrics - methods
Pharmacology. Drug treatments
Prospective Studies
Short Reports
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Summary:To investigate the potential relationship between off-label drug use and increased risk of adverse drug reactions in paediatric outpatients. A prospective pharmacovigilance survey of drug prescribing in office based paediatricians was carried out in Haute-Garonne County (south west of France). 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). 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.
ISSN:0306-5251
1365-2125
DOI:10.1046/j.1365-2125.2002.t01-3-01689.x