| アブストラクト | AIM: Term and preterm neonates are at high risk for serious adverse drug reactions (ADRs). METHODS: A descriptive study of reports registered in the French pharmacovigilance database from 1986 to 2012 were obtained. All reports concerning neonates (</=1 month of life) with direct drug exposure were retrieved. Characteristics of the reports, including reported ADR(s), drug(s) and the causality assessment using the French causality assessment method, were described. RESULTS: A total of 1688 reports were analyzed and more than half of them were classified as serious (n = 995). Median age at ADR occurrence was 9 days. Overall, 3127 ADRs were described in these reports in relation to 2238 suspect/interacting drugs. The most commonly reported system organ classes (SOCs) were injury, poisoning and procedural complications (16%), general disorders and administration site conditions (12.5%) and blood and lymphatic system disorders (12%). In the majority of ADRs reported (73%), infants fully recovered and less than 4% of neonates deceased as a consequence of the reported ADR. One out of five ADRs was associated with drug administration errors. Therapeutic classes commonly incriminated were anti-infectives, nervous system and alimentary tract drugs. Substances most frequently related to serious ADRs were zidovudine, ibuprofen and nevirapine. Among the 10 most frequently encountered drug-ADR pairs, two substances were mainly implicated, zidovudine in haematological adverse reactions and phytomenadione in maladministrations. CONCLUSIONS: Anti-infective drugs, mainly antiretroviral therapy, account for the majority of ADRs reported in neonates. The specific issue of drug maladministration and medication errors remains to be addressed in neonates. |
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| ジャーナル名 | British journal of clinical pharmacology |
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| 投稿日 | 2016/6/9 |
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| 投稿者 | Kaguelidou, Florentia; Beau-Salinas, Frederique; Jonville-Bera, Annie Pierre; Jacqz-Aigrain, Evelyne |
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| 組織名 | EA 08, University of Paris Diderot, Sorbonne Paris Cite, F-75010, Paris.;florentia.kaguelidou@rdb.aphp.fr.;Inserm, CIC 1426, F-75019, Paris. florentia.kaguelidou@rdb.aphp.fr.;Department of Pediatric Pharmacology and Pharmacogenetics, AP-HP, Hopital Robert;Debre, F-75019, Paris. florentia.kaguelidou@rdb.aphp.fr.;CHRU of Tours, Department of Clinical Pharmacology, Regional Centre of;Pharmacovigilance, F-37 044, Tours, France.;Inserm, CIC 1426, F-75019, Paris.;Debre, F-75019, Paris. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/27276109/ |
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