| アブストラクト | AIM: To describe the adverse drug reactions (ADR) and the drugs involved in pediatrics. METHODS: An observational study on all ADR notifications recorded in the French pharmacovigilance database by the Regional Pharmacovigilance Center of Champagne-Ardenne between 1 January 1985 and 31 December 2014 involving children from 0 to 17 years inclusive was performed. For all notifications, we studied the patient and the ADR characteristics. RESULTS: During the study period, 632 notifications were collected. The most frequently reported ATC (anatomical, therapeutic and chemical) classes were vaccines (15.9%), antineoplastics (12%) and antibiotics (11.1%). Forty-six percent of the notifications were serious. For serious ADRs, the most involved drugs were paracetamol, asparaginase and ibuprofen. Skin reactions were the most often reported ADRs. The most common lowest level terms (LLT) were urticaria (4.9%), hypersensitivity (4.1%), fever (2.9%) and vomiting (2.8%). CONCLUSION: ADR reporting to the pharmacovigilance system, in particular pediatric ADRs, should be encouraged. Information on the use of medicinal products, especially on self-medication use, need to be improve. |
|---|
| ジャーナル名 | Therapie |
|---|
| Pubmed追加日 | 2016/5/21 |
|---|
| 投稿者 | Saint-Martin, Caroline; Kanagaratnam, Lukshe; de Boissieu, Paul; Azzouz, Brahim; Abou Taam, Malak; Trenque, Thierry |
|---|
| 組織名 | Centre regional de pharmacovigilance et de pharmaco-epidemiologie de;Champagne-Ardenne, CHU de Reims, 51092 Reims, France.;Unite d'aide methodologique, pole recherche et innovations, CHU de Reims, 51092;Reims, France; EA 3797, faculte de medecine, universite de Reims;Champagne-Ardenne, 51100 Reims, France.;Champagne-Ardenne, CHU de Reims, 51092 Reims, France; EA 3797, faculte de;medecine, universite de Reims Champagne-Ardenne, 51100 Reims, France.;medecine, universite de Reims Champagne-Ardenne, 51100 Reims, France. Electronic;address: ttrenque@chu-reims.fr. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/27203165/ |
|---|
