Document Detail

Cutaneous adverse drug reactions reported in children: a national register-based study.
MedLine Citation:
PMID:  22762709     Owner:  NLM     Status:  Publisher    
Background:  Cutaneous adverse drug reactions (CADRs) are the most common type of adverse drug reactions (ADRs) reported in the paediatric population, but they are rarely considered serious, despite that serious cases have been reported. Objective:  To characterise CADRs reported to the Danish national ADR database from 1998 to 2007. Methods:  We included reports submitted for children less than 18 years of age and extracted information about ADRs involving skin and subcutaneous disorders. ADRs were classified according to type, medications, seriousness, and age and gender of child. The unit of analysis was one ADR. Results:  We analysed 2437 reports corresponding to 4500 ADRs, and 674 of these ADRs reported information about CADRs. One quarter (N = 174) of all CADRs were serious including two fatal cases. More than half of CADRs were reported in children less than two years of age, and there was an equal distribution of number of reports for the two genders. The majority of CADRs were reported for anti-infectives for systemic use (66% of total CADRs), followed by nervous system medications (16% of total CADRs) and dermatologic agents (10% of total CADRs). The largest number of reported CADRs was labelled with the term 'rash'. Serious cases such as erythema/erythema multiforme and urticaria were reported. Conclusions:  One-fifth of all ADRs reported over a decade were cutaneous, and one-third of them serious. Prescribers should be aware of the risk of the occurrence of dermatological ADRs in children from medications for systemic use as well as dermatological agents.
L Aagaard; E H Hansen
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Publication Detail:
Type:  LETTER     Date:  2012-7-4
Journal Detail:
Title:  The British journal of dermatology     Volume:  -     ISSN:  1365-2133     ISO Abbreviation:  -     Publication Date:  2012 Jul 
Date Detail:
Created Date:  2012-7-5     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0004041     Medline TA:  Br J Dermatol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 British Association of Dermatologists.
Department of Clinical Pharmacology, Faculty of Health, University of Southern Denmark Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen Danish Pharmacovigilance Research Project (DANPREP), Copenhagen, Denmark.
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