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Adverse drug reactions and off-label drug use in paediatric outpatients
Open accessAbstract
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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Cited by
Development and Evaluation of a Generic Physiologically Based Pharmacokinetic Model for Children
Edginton, A. N., Schmitt, W., & Willmann, S. (2006) · Clinical Pharmacokinetics · doi:10.2165/00003088-200645100-00005 · Cited by 357
A literature review on off-label drug use in children
Pandolfini, C., & Bonati, M. (2005) · European Journal of Pediatrics · doi:10.1007/s00431-005-1698-8 · Cited by 346
Medication Use in the Neonatal Intensive Care Unit
Hsieh, E., Hornik, C., Clark, R., Laughon, M., Benjamin, D., Smith, P., & on Behalf of the Best Pharmaceuticals for Children Act—Pediatric Trials Network (2013) · American Journal of Perinatology · doi:10.1055/s-0033-1361933 · Cited by 318
Bellis, J. R., Kirkham, J. J., Nunn, A. J., & Pirmohamed, M. (2014) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.12222 · Cited by 120
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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- 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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