Abstract:
PURPOSE:Our objective was to examine the numbers and characteristics of US pediatric adverse events (AEs) reported to the Food and Drug Administration (FDA)'s adverse event reporting system (AERS) for 5 years following implementation of the Best Pharmaceuticals for Children Act (BPCA) in 2002. METHODS:We analyzed reports in AERS received by FDA from January 1, 2003 to January 1, 2008 for overall numbers, age, gender, and seriousness of outcome in children and adults. Pediatric and adult age groups (<2, 2-10, 11-17, 18-50, and >50 years of age) were further evaluated for most frequently reported suspect drug classes and AEs. RESULTS:Seventy-two percent of 815 267 crude count reports had specified age information. Six percent of the total reports with age information reported age <18 years. Numbers of AEs being reported for children have remained steady, while those for adults have increased. The proportion of serious AEs reported was similar for pediatrics as compared to adults. Frequently reported suspect drug classes noted in pediatric age groups that were not observed in adults included anticonvulsants, attention deficit hyperactivity disorder (ADHD), anti-acne, and respiratory medications. CONCLUSIONS:This overview highlights the need for strengthening the passive drug surveillance system from a pediatric perspective, as well as investing in more active surveillance systems. Drug safety initiatives to better capture risk information in order to balance the risk/benefit of drug use in children.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Johann-Liang R,Wyeth J,Chen M,Cope JUdoi
10.1002/pds.1679subject
Has Abstractpub_date
2009-01-01 00:00:00pages
24-7issue
1eissn
1053-8569issn
1099-1557journal_volume
18pub_type
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journal_title:Pharmacoepidemiology and drug safety
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更新日期:2019-09-01 00:00:00
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更新日期:2010-04-01 00:00:00
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更新日期:2012-01-01 00:00:00
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更新日期:2013-11-01 00:00:00
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更新日期:2012-01-01 00:00:00
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更新日期:2017-09-01 00:00:00
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pub_type: 杂志文章,随机对照试验
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更新日期:2017-10-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(sici)1099-1557(199808)7:1+
更新日期:1998-08-01 00:00:00
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更新日期:2018-07-01 00:00:00
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更新日期:2018-06-01 00:00:00
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更新日期:2012-11-01 00:00:00
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更新日期:2013-05-01 00:00:00
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pub_type: 杂志文章
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更新日期:2014-11-01 00:00:00
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更新日期:2009-05-01 00:00:00