Affiliations: Pharmacoepidemiology Unit, Departments of Medical
Informatics and Epidemiology & Biostatistics, Erasmus University Medical
Center, Rotterdam, The Netherlands | I.RI.D.I.A. srl, Health Care Engineering, Bari,
Italy | Consorzio per Valutazioni Biologiche e Farmacologiche,
Pavia, Italy | Centre for Paediatric Pharmacy Research, The School of
Pharmacy and Institute of Child Health, University of London, London,
UK | Consiglio Nazionale delle Ricerche - Istituto di
Tecnologie Biomediche, Milan, Italy
Note: [] Corresponding author: Adriana Ceci, Consorzio per Valutazioni
Biologiche e Farmacologiche, Via Palestro 26, 27100 Pavia, Italy. Tel.: +39
0382 25075; Fax: +39 0382 536544; E-mail: aceci@cvbf.net
Abstract: The mission statement of the TEDDY project is to promote the
research on the safe and effective use of drugs in children and to expand and
integrate the knowledge and to build research capacity in the drug development
for children. One of the activities of WP1 – pharmacoepidemiology was to study
the frequency and type of ADR reporting in children. For this analysis, we used
data from the Uppsala Monitoring Centre (WHO collaborating Centre for
International Drug Monitoring). All reports on ADRs in children
(< 18 years), sent to the monitoring centre between 2000 and
2004 were analysed. This report contains the first results on the ADR reporting in
children. Within this report, we mainly focus on the occurrence of ADRs with a
fatal outcome. In further analysis, we will further explore the association
between causal related deaths and the use of specific drugs.
Keywords: TEDDY, ADRs report, pharmacoepidemiology, children, WHO
