Document Detail

Adverse drug reactions in newborns, infants and toddlers: pediatric pharmacovigilance between present and future.
MedLine Citation:
PMID:  21548838     Owner:  NLM     Status:  MEDLINE    
INTRODUCTION: The detection, assessment, understanding and prevention of adverse drug reactions (ADRs) are the primary aims of pharmacovigilance activities. Pediatric patients, especially all newborns and infants, are particularly at risk for experiencing drug-related adverse events.
AREAS COVERED: This review briefly analyzes the physiological peculiarities of pharmacodynamic and pharmacokinetic aspects of drugs in newborns, infants and toddlers and children. It also deals with specific pediatric pharmacovigilance aspects, such as the frequent use of unlicensed and/or off-label drugs in neonatal intensive care units in European countries and in Australia. This review reports on European, American and Canadian data about the incidence and type of pediatric ADRs, particularly focusing on neonates, infants and toddlers.
EXPERT OPINION: The awareness of pediatricians about the importance of reporting ADRs should be stimulated, new reporting systems should be encouraged and pediatric pharmacovigilance activities should be improved, first, by intensifying active post-marketing surveillance methods.
Valentina Fabiano; Chiara Mameli; Gian Vincenzo Zuccotti
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Publication Detail:
Type:  Journal Article; Review     Date:  2011-05-09
Journal Detail:
Title:  Expert opinion on drug safety     Volume:  11     ISSN:  1744-764X     ISO Abbreviation:  Expert Opin Drug Saf     Publication Date:  2012 Jan 
Date Detail:
Created Date:  2011-12-26     Completed Date:  2012-04-20     Revised Date:  2013-11-06    
Medline Journal Info:
Nlm Unique ID:  101163027     Medline TA:  Expert Opin Drug Saf     Country:  England    
Other Details:
Languages:  eng     Pagination:  95-105     Citation Subset:  IM    
Luigi Sacco Hospital, Department of Pediatrics, Università degli Studi di Milano, Via GB Grassi, 74, 20157, Milan, Italy.
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MeSH Terms
Adverse Drug Reaction Reporting Systems*
Age Factors
Child, Preschool
Infant, Newborn
Off-Label Use
Pharmaceutical Preparations / administration & dosage,  adverse effects*
Reg. No./Substance:
0/Pharmaceutical Preparations

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