A systematic review of adverse drug events associated with administration of common asthma medications in children.

<h4>Objective</h4>To systematically review the literature and determine frequencies of adverse drug events (ADE) associated with pediatric asthma medications.<h4>Methods</h4>Following PRISMA guidelines, we systematically searched six bibliographic databases between January 19...

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Main Authors: James S Leung, David W Johnson, Arissa J Sperou, Jennifer Crotts, Erik Saude, Lisa Hartling, Antonia Stang
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2017-01-01
Series:PLoS ONE
Online Access:https://doi.org/10.1371/journal.pone.0182738
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author James S Leung
David W Johnson
Arissa J Sperou
Jennifer Crotts
Erik Saude
Lisa Hartling
Antonia Stang
author_facet James S Leung
David W Johnson
Arissa J Sperou
Jennifer Crotts
Erik Saude
Lisa Hartling
Antonia Stang
author_sort James S Leung
collection DOAJ
description <h4>Objective</h4>To systematically review the literature and determine frequencies of adverse drug events (ADE) associated with pediatric asthma medications.<h4>Methods</h4>Following PRISMA guidelines, we systematically searched six bibliographic databases between January 1991 and January 2017. Study eligibility, data extraction and quality assessment were independently completed and verified by two reviewers. We included randomized control trials (RCT), case-control, cohort, or quasi-experimental studies where the primary objective was identifying ADE in children 1 month- 18 years old exposed to commercial asthma medications. The primary outcome was ADE frequency.<h4>Findings</h4>Our search identified 14,540 citations. 46 studies were included: 24 RCT, 15 cohort, 4 RCT pooled analyses, 1 case-control, 1 open-label trial and 1 quasi-experimental study. Studies examined the following drug classes: inhaled corticosteroids (ICS) (n = 24), short-acting beta-agonists (n = 10), long-acting beta-agonists (LABA) (n = 3), ICS + LABA (n = 3), Leukotriene Receptor Antagonists (n = 3) and others (n = 3). 29 studies occurred in North America, and 29 were industry funded. We report a detailed index of 406 ADE descriptions and frequencies organized by drug class. The majority of data focuses on ICS, with 174 ADE affecting 13 organ systems including adrenal and growth suppression. We observed serious ADE, although they were rare, with frequency ranging between 0.9-6% per drug. There were no confirmed deaths, except for 13 potential deaths in a LABA study including combined adult and pediatric participants. We identified substantial methodological concerns, particularly with identifying ADE and determining severity. No studies utilized available standardized causality, severity or preventability assessments.<h4>Conclusion</h4>The majority of studies focus on ICS, with adrenal and growth suppression described. Serious ADE are relatively uncommon, with no confirmed pediatric deaths. We identify substantial methodological concerns, highlighting need for standardization with future research examining pediatric asthma medication safety.
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spelling doaj-art-5d93d51b42c84ada9b16c97e43b4a82a2025-06-25T05:31:41ZengPublic Library of Science (PLoS)PLoS ONE1932-62032017-01-01128e018273810.1371/journal.pone.0182738A systematic review of adverse drug events associated with administration of common asthma medications in children.James S LeungDavid W JohnsonArissa J SperouJennifer CrottsErik SaudeLisa HartlingAntonia Stang<h4>Objective</h4>To systematically review the literature and determine frequencies of adverse drug events (ADE) associated with pediatric asthma medications.<h4>Methods</h4>Following PRISMA guidelines, we systematically searched six bibliographic databases between January 1991 and January 2017. Study eligibility, data extraction and quality assessment were independently completed and verified by two reviewers. We included randomized control trials (RCT), case-control, cohort, or quasi-experimental studies where the primary objective was identifying ADE in children 1 month- 18 years old exposed to commercial asthma medications. The primary outcome was ADE frequency.<h4>Findings</h4>Our search identified 14,540 citations. 46 studies were included: 24 RCT, 15 cohort, 4 RCT pooled analyses, 1 case-control, 1 open-label trial and 1 quasi-experimental study. Studies examined the following drug classes: inhaled corticosteroids (ICS) (n = 24), short-acting beta-agonists (n = 10), long-acting beta-agonists (LABA) (n = 3), ICS + LABA (n = 3), Leukotriene Receptor Antagonists (n = 3) and others (n = 3). 29 studies occurred in North America, and 29 were industry funded. We report a detailed index of 406 ADE descriptions and frequencies organized by drug class. The majority of data focuses on ICS, with 174 ADE affecting 13 organ systems including adrenal and growth suppression. We observed serious ADE, although they were rare, with frequency ranging between 0.9-6% per drug. There were no confirmed deaths, except for 13 potential deaths in a LABA study including combined adult and pediatric participants. We identified substantial methodological concerns, particularly with identifying ADE and determining severity. No studies utilized available standardized causality, severity or preventability assessments.<h4>Conclusion</h4>The majority of studies focus on ICS, with adrenal and growth suppression described. Serious ADE are relatively uncommon, with no confirmed pediatric deaths. We identify substantial methodological concerns, highlighting need for standardization with future research examining pediatric asthma medication safety.https://doi.org/10.1371/journal.pone.0182738
spellingShingle James S Leung
David W Johnson
Arissa J Sperou
Jennifer Crotts
Erik Saude
Lisa Hartling
Antonia Stang
A systematic review of adverse drug events associated with administration of common asthma medications in children.
PLoS ONE
title A systematic review of adverse drug events associated with administration of common asthma medications in children.
title_full A systematic review of adverse drug events associated with administration of common asthma medications in children.
title_fullStr A systematic review of adverse drug events associated with administration of common asthma medications in children.
title_full_unstemmed A systematic review of adverse drug events associated with administration of common asthma medications in children.
title_short A systematic review of adverse drug events associated with administration of common asthma medications in children.
title_sort systematic review of adverse drug events associated with administration of common asthma medications in children
url https://doi.org/10.1371/journal.pone.0182738
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