Florentia Kaguelidou1,2,3, Frédérique Beau-Salinas4, Annie Pierre Jonville-Bera4, Evelyne Jacqz-Aigrain5,6,7. 1. EA 08, University of Paris Diderot, Sorbonne Paris Cité, F-75010, Paris. florentia.kaguelidou@rdb.aphp.fr. 2. Inserm, CIC 1426, F-75019, Paris. florentia.kaguelidou@rdb.aphp.fr. 3. Department of Pediatric Pharmacology and Pharmacogenetics, AP-HP, Hôpital Robert Debré, F-75019, Paris. florentia.kaguelidou@rdb.aphp.fr. 4. CHRU of Tours, Department of Clinical Pharmacology, Regional Centre of Pharmacovigilance, F-37 044, Tours, France. 5. EA 08, University of Paris Diderot, Sorbonne Paris Cité, F-75010, Paris. 6. Inserm, CIC 1426, F-75019, Paris. 7. Department of Pediatric Pharmacology and Pharmacogenetics, AP-HP, Hôpital Robert Debré, F-75019, Paris.
Abstract
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.
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.
Authors: S Blanche; M Tardieu; P Rustin; A Slama; B Barret; G Firtion; N Ciraru-Vigneron; C Lacroix; C Rouzioux; L Mandelbrot; I Desguerre; A Rötig; M J Mayaux; J F Delfraissy Journal: Lancet Date: 1999-09-25 Impact factor: 79.321
Authors: Z Bárzaga Arencibia; A López Leyva; Y Mejías Peña; A R González Reyes; E Fernández Manzano; I Choonara Journal: Eur J Clin Pharmacol Date: 2012-02-08 Impact factor: 2.953
Authors: Rachel S Meyers; Jennifer Thackray; Kelly L Matson; Christopher McPherson; Lisa Lubsch; Robert C Hellinga; David S Hoff Journal: J Pediatr Pharmacol Ther Date: 2020