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Article: Pediatric Drug Safety Surveillance in FDA-AERS: A Description of Adverse Events from GRiP Project

TitlePediatric Drug Safety Surveillance in FDA-AERS: A Description of Adverse Events from GRiP Project
Authors
Issue Date2015
PublisherPublic Library of Science. The Journal's web site is located at http://www.plosone.org/home.action
Citation
Plos One, 2015, v. 10 n. 6, p. e0130399 How to Cite?
AbstractIndividual case safety reports (ICSRs) are a cornerstone in drug safety surveillance. The knowledge on using these data specifically for children is limited. We studied characteristics of pediatric ICSRs reported to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Public available ICSRs reported in children (0-18 years) to FAERS were downloaded from the FDA-website for the period Jan 2004-Dec 2011. Characteristics of these ICSRs, including the reported drugs and events, were described and stratified by age-groups. We included 106,122 pediatric ICSRs (55% boys and 58% from United States) with a median of 1 drug [range 1-3] and 1 event [1-2] per ICSR. Mean age was 9.1 years. 90% was submitted through expedited (15-days) (65%) or periodic reporting (25%) and 10% by non-manufacturers. The proportion and type of pediatric ICSRs reported were relatively stable over time. Most commonly reported drug classes by decreasing frequency were 'nervous system drugs' (58%), 'antineoplastics' (32%) and 'anti-infectives' (25%). Most commonly reported system organ classes were 'general' (13%), 'nervous system' (12%) and 'psychiatric' (11%) disorders. Duration of use could be calculated for 19.7% of the reported drugs, of which 14.5% concerned drugs being used long-term (>6 months). Knowledge on the distribution of the drug classes and events within FAERS is a key first step in developing pediatric specific methods for drug safety surveillance. Because of several differences in terms of drugs and events among age-categories, drug safety signal detection analysis in children needs to be stratified by each age group.
Persistent Identifierhttp://hdl.handle.net/10722/227039
ISSN
2015 Impact Factor: 3.057
2015 SCImago Journal Rankings: 1.395
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorde Bie, S-
dc.contributor.authorFerrajolo, C-
dc.contributor.authorStraus, SMJM-
dc.contributor.authorVerhamme, KMC-
dc.contributor.authorBonhoeffer, J-
dc.contributor.authorWong, ICK-
dc.contributor.authorSturkenboom, MCJM-
dc.date.accessioned2016-07-15T06:31:26Z-
dc.date.available2016-07-15T06:31:26Z-
dc.date.issued2015-
dc.identifier.citationPlos One, 2015, v. 10 n. 6, p. e0130399-
dc.identifier.issn1932-6203-
dc.identifier.urihttp://hdl.handle.net/10722/227039-
dc.description.abstractIndividual case safety reports (ICSRs) are a cornerstone in drug safety surveillance. The knowledge on using these data specifically for children is limited. We studied characteristics of pediatric ICSRs reported to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Public available ICSRs reported in children (0-18 years) to FAERS were downloaded from the FDA-website for the period Jan 2004-Dec 2011. Characteristics of these ICSRs, including the reported drugs and events, were described and stratified by age-groups. We included 106,122 pediatric ICSRs (55% boys and 58% from United States) with a median of 1 drug [range 1-3] and 1 event [1-2] per ICSR. Mean age was 9.1 years. 90% was submitted through expedited (15-days) (65%) or periodic reporting (25%) and 10% by non-manufacturers. The proportion and type of pediatric ICSRs reported were relatively stable over time. Most commonly reported drug classes by decreasing frequency were 'nervous system drugs' (58%), 'antineoplastics' (32%) and 'anti-infectives' (25%). Most commonly reported system organ classes were 'general' (13%), 'nervous system' (12%) and 'psychiatric' (11%) disorders. Duration of use could be calculated for 19.7% of the reported drugs, of which 14.5% concerned drugs being used long-term (>6 months). Knowledge on the distribution of the drug classes and events within FAERS is a key first step in developing pediatric specific methods for drug safety surveillance. Because of several differences in terms of drugs and events among age-categories, drug safety signal detection analysis in children needs to be stratified by each age group.-
dc.languageeng-
dc.publisherPublic Library of Science. The Journal's web site is located at http://www.plosone.org/home.action-
dc.relation.ispartofPlos One-
dc.rightsCreative Commons: Attribution 3.0 Hong Kong License-
dc.titlePediatric Drug Safety Surveillance in FDA-AERS: A Description of Adverse Events from GRiP Project-
dc.typeArticle-
dc.identifier.emailWong, ICK: wongick@hku.hk-
dc.identifier.authorityWong, ICK=rp01480-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1371/journal.pone.0130399-
dc.identifier.pmid26090678-
dc.identifier.volume10-
dc.identifier.issue6-
dc.identifier.spagee0130399-
dc.identifier.epagee0130399-
dc.identifier.isiWOS:000356835000112-
dc.publisher.placeUnited States-

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