Benjamin Horen1, Jean-Louis Montastruc, Maryse Lapeyre-Mestre. 1. Laboratoire de Pharmacologie Médicale et Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et dInformations sur le médicament, Faculté de Médecine.
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.
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.
Authors: Peter J Helms; Suzie Ekins Daukes; Michael W Taylor; Colin R Simpson; James S McLay Journal: Br J Clin Pharmacol Date: 2005-06 Impact factor: 4.335
Authors: Kazeem A Oshikoya; Gerold T Wharton; Debbie Avant; Sara L Van Driest; Norman E Fenn; Allison Lardieri; Edwin Doe; Beena G Sood; Carol Taketomo; Phuong Lieu; Lilly Yen; Ann W McMahon Journal: Paediatr Drugs Date: 2019-02 Impact factor: 3.022