Document Detail


Drugs Associated with Adverse Events in Children and Adolescents.
MedLine Citation:
PMID:  24990656     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
OBJECTIVE: To describe the suspected medications, types of reactions, and outcomes of adverse events (AEs) most commonly reported to the United States Food and Drug Administration (FDA) in children by age group.
METHODS: All case reports submitted to the FDA Adverse Event Reporting System (FAERS) between January 1, 2007, and August 27, 2012, for children (1 to < 12 yrs) and adolescents (12 to < 18 yrs) were examined. The most commonly reported suspected drugs were ranked. The corresponding AEs with serious outcome were compared and described between age groups.
RESULTS: We identified a total of 78,623 reports in the FAERS database (53.8% in children and 46.2% in adolescents). Serious outcomes were noted in 40% of the children and 43% of the adolescents. The proportion of all case reports for central nervous system stimulants (lisdexamfetamine, 69.8%; methylphenidate, 68.0%) and analgesics (ibuprofen, 72.3%; acetaminophen, 68.6%) was higher in children, whereas tumor necrosis factor blockers (infliximab, 78.2%; adalimumab, 77.1%), atypical antipsychotics (aripiprazole 52.7%; risperidone 58.3%; quetiapine 72.1%) and oral contraceptives (levonogrestrel, 99.2%; drospirenone and ethinyl estradiol, 97.9%) were more commonly reported in adolescents. For most drugs, the types of reactions reported were similar but had different rank order across age groups, with the most dissimilar profiles being observed for isotretinoin and aripiprazole.
CONCLUSIONS: This study highlights high-risk medications and their AE profiles in children and adolescents. Our findings underscore the need for further confirmation of particular drug and AE pairs and the heterogeneity of AEs by age.
Authors:
Wan-Ju Lee; Todd A Lee; A Simon Pickard; Rachel N Caskey; Glen T Schumock
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-7-3
Journal Detail:
Title:  Pharmacotherapy     Volume:  -     ISSN:  1875-9114     ISO Abbreviation:  Pharmacotherapy     Publication Date:  2014 Jul 
Date Detail:
Created Date:  2014-7-3     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8111305     Medline TA:  Pharmacotherapy     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2014 Pharmacotherapy Publications, Inc.
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