| アブストラクト | INTRODUCTION: Studies that evaluate the safety of non-prescription drugs in children remain scarce. OBJECTIVES: The aim of the present study was to compare adverse drug reactions (ADRs) due to prescription versus non-prescription drugs in children. METHODS: We conducted a retrospective analysis of ADR notifications for a pediatric population (aged <18 years) registered in the French PharmacoVigilance Database (FPVD) between January 1985 and December 2016 by the Midi-Pyrenees PharmacoVigilance Center (in the south of France). We compared ADR profiles according to drug prescription status using a Chi-squared test. RESULTS: We included 2218 notifications concerning 3687 ADRs in the study. Non-prescription drugs were involved in 506 notifications (22.8%). Patients were younger in the non-prescription drug group (6.7 +/- 5.3 vs. 8.4 +/- 5.7 years in the prescription drug group). No difference by sex was found. Neurological ADRs were more frequent with prescription drugs (21.0%) than with non-prescription drugs (14.2%, p = 0.0008), whereas dermatological disorders (37.2 vs. 29.1%, respectively) and general ADRs (30.8 vs. 20.1%, respectively) were more frequent with non-prescription than with prescription drugs (p = 0.0006 and p < 0.0001, respectively). The frequency of "serious" ADRs was higher with prescription drugs than with non-prescription drugs (40.9 vs. 34.2%, p = 0.007). The non-prescription drugs most frequently implicated with serious ADRs were ibuprofen (n = 37; 4.2%), tuberculosis vaccine (n = 23; 2.6%), aspirin (n = 20, 2.3%), and paracetamol (n = 17; 1.9%). ADRs from prescription drugs involved asparaginase (n = 27; 3.1%), immunoglobulins (n = 25; 2.9%), and amoxicillin (n = 23; 2.4%). CONCLUSIONS: Non-prescription drugs, usually considered safe, were frequently responsible for ADR notifications. The non-prescription medication most frequently involved in serious ADRs was ibuprofen. |
|---|
| ジャーナル名 | Paediatric drugs |
|---|
| 投稿日 | 2017/8/3 |
|---|
| 投稿者 | Durrieu, Genevieve; Maupiler, Mathieu; Rousseau, Vanessa; Chebane, Leila; Montastruc, Francois; Bondon-Guitton, Emmanuelle; Montastruc, Jean-Louis |
|---|
| 組織名 | Service de Pharmacologie Medicale et Clinique, Centre Midi-Pyrenees de;PharmacoVigilance, de Pharmacoepidemiologie et d'Informations sur les;Medicaments, Pharmacopole Midi-Pyrenees, Toulouse University Hospital, UMR1027;INSERM Pharmacoepidemiology Unit, Faculty of Medicine, University of Toulouse,;Toulouse, France. genevieve.durrieu@univ-tlse3.fr.;Laboratoire de Pharmacologie Medicale et Clinique, Faculte de Medecine, 37 Allees;Jules Guesde, 31000, Toulouse, France. genevieve.durrieu@univ-tlse3.fr.;Toulouse, France. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/28766184/ |
|---|
