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

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Horen, Benjamin, Montastruc, Jean-Louis, Lapeyre-Mestre, Maryse·2002·British Journal of Clinical Pharmacology

Abstract

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.

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Metadata

Authors
Horen, B., Montastruc, J.-L., & Lapeyre-Mestre, M.
Venue
British Journal of Clinical Pharmacology
Publisher
Wiley
Published
2002-12
Volume
54
Issue
6
Pages
665-670
ISSN
  • 0306-5251 (ISSN-L)
  • 1365-2125
OpenAlex
W1984710954
Cited by
294
References
0
FWCI
9.41
Type
journal article
Language
en
Open access
green

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CoChat. (2026). Citation check: Adverse drug reactions and off-label drug use in paediatric outpatients. https://app.cochat.ai/papers/10.1046/j.1365-2125.2002.t01-3-01689.x
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Horen, B., Montastruc, J.-L., & Lapeyre-Mestre, M. (2002). Adverse drug reactions and off-label drug use in paediatric outpatients. British Journal of Clinical Pharmacology. https://doi.org/10.1046/j.1365-2125.2002.t01-3-01689.x

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