Abstract
ObjectiveTo systematically review the literature and determine frequencies of adverse drug events (ADE) associated with pediatric asthma medications.MethodsFollowing 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.FindingsOur 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.ConclusionThe 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.
Highlights
Asthma medications are frequently prescribed to children, regardless of a clear-cut diagnosis of asthma, which is difficult in pre-school aged children and infants who present with bronchiolitis.[3]
Utilizing a rigorous study design, we conducted a broad-based systematic review on Adverse Drug Events (ADE) associated with asthma medications in children
A key finding from our review was the identification of substantial methodological issues with respect to both study design and the identification and reporting of ADE in the Adverse drug events and common pediatric asthma medications: A systematic review existing literature
Summary
Wheeze is a common childhood problem, affecting one in three children before their third birthday, and almost 50% by 6 years of age.[1, 2] To treat this wheeze, asthma medications are frequently prescribed to children, regardless of a clear-cut diagnosis of asthma, which is difficult in pre-school aged children and infants who present with bronchiolitis.[3]. The Global Initiative for Asthma (GINA) describes the following classes of medications to be used with asthmatic patients: short-acting beta agonists (SABA), inhaled corticosteroids (ICS), long-acting beta agonists (LABA), leukotriene receptor antagonists (LTRA), systemic corticosteroids (SCS) and IgE Immunomodulators (Anti-IgE).[6] Despite their common use, [7, 8] there is a paucity in understanding ADE associated with common asthma medications in children. A broad systematic review focusing on ADR in children excluded studies focusing on asthma.[9] We conducted a systematic review with the primary objective to determine the frequency of all ADE associated with commonly used asthma medications in children. Our secondary objectives were to describe the causality, severity and preventability of these ADE
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