Systematic review of paediatric studies of adverse drug reactions from pharmacovigilance databases

Cliff-Eribo, Kennedy Obebi and Sammons, Helen and Choonara, Imti (2016) Systematic review of paediatric studies of adverse drug reactions from pharmacovigilance databases. Expert Opinion on Drug Safety . pp. 1321-1328. ISSN 1744-764X

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Objective: To perform a systematic review of studies describing paediatric adverse drug reactions (ADRs) conducted from national pharmacovigilance databases.

Methods: A systematic literature search of studies describing results for paediatric ADRs from national pharmacovigilance databases was performed. PubMed database, Embase and MEDLINE were searched up to March 2015. The descriptive studies included were analysed for country of origin, reporters, and ADR reporting rate, drugs, ADRs and number of fatalities.

Results: 20 studies were identified. Doctors were the largest group of reporters in all the studies, and with more consumer reports seen in USA. The studies ranged from 3 – 37 years. The highest ADR reporting rate was 1458 reports per year per million children in Cuba. Antibiotics and vaccines were the most frequently reported drugs, in almost all the studies. The most frequent ADRs were skin and nervous system disorders. The highest proportion of fatalities and serious reports was from North America. Drugs used for treating attention deficit hyperactivity disorders (ADHD) and isotretinoin were the most frequently reported drugs for ADRs in North America.

Conclusions: There were geographical differences in drugs responsible for ADRs and their seriousness, especially in North America. Very few studies were conducted in Asia and Latin America, none were found from Africa.

Item Type: Article
Additional Information: This is an Accepted Manuscript of an article published by Taylor & Francis in Expert Opinion on Drug Safety on 22 August 2016, available online:
Keywords: Adverse drug reactions, paediatric, spontaneous reporting system, pharmacovigilance database
Schools/Departments: University of Nottingham UK Campus > Faculty of Medicine and Health Sciences > School of Medicine > Division of Medical Sciences and Graduate Entry Medicine
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Depositing User: Bowler, Henry
Date Deposited: 27 Sep 2016 11:18
Last Modified: 29 Sep 2016 04:11

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