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Neonatal adverse drug reactions: an analysis of reports to the French pharmacovigilance database
Author(s) -
Kaguelidou Florentia,
BeauSalinas Frédérique,
JonvilleBera Annie Pierre,
JacqzAigrain Evelyne
Publication year - 2016
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/bcp.13034
Subject(s) - pharmacovigilance , medicine , drug , nevirapine , adverse drug reaction , adverse effect , pediatrics , drug reaction , dyscrasia , database , drug withdrawal , pharmacology , intensive care medicine , human immunodeficiency virus (hiv) , family medicine , antiretroviral therapy , viral load , computer science , plasma cell , multiple myeloma
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.