Safety of azithromycin in pediatrics: a systematic review and meta-analysis

Zeng, Linan; Xu, Peipei; Choonara, Imti; Bo, Zhenyan; Pan, Xiangchen; Li, Wenyan; Ni, Xiaofeng; Xiong, Tao; Chen, Can; Huang, Leshan; Qazi, Shamim; Mu, Dezhi; Zhang, Lingli

doi:10.1007/s00228-020-02956-3

Cited by 20 publications

(16 citation statements)

References 46 publications

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“…In general, due to its broad antibacterial spectrum and safety profile, azithromycin is one of the most commonly prescribed antibacterials in children. In the last two decades, over 700 million doses of MDA-azithromycin have been delivered to children [ 38 ]. However, the safety of azithromycin use in infants is debated.…”

Section: Methodsmentioning

confidence: 99%

“…The most commonly reported side effects were abdominal pain (53.1%), nausea (21.7%), vomiting (12.8%), and diarrhea (12.5%). However, the prevalence of side effects in the placebo group was not reported [ 38 , 39 ]. In a systematic review of neonates (< 28 days) who received at least one dose of azithromycin, data from 4 RCTs indicated that gastrointestinal side effects were seen in 19.6% of patients [ 40 ].…”

Section: Methodsmentioning

confidence: 99%

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Mass drug administration of antibacterials: weighing the evidence regarding benefits and risks

2022

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Background Mass drug administration (MDA) is a strategy to improve health at the population level through widespread delivery of medicine in a community. We surveyed the literature to summarize the benefits and potential risks associated with MDA of antibacterials, focusing predominantly on azithromycin as it has the greatest evidence base. Main body High-quality evidence from randomized controlled trials (RCTs) indicate that MDA-azithromycin is effective in reducing the prevalence of infection due to yaws and trachoma. In addition, RCTs suggest that MDA-azithromycin reduces under-five mortality in certain low-resource settings that have high childhood mortality rates at baseline. This reduction in mortality appears to be sustained over time with twice-yearly MDA-azithromycin, with the greatest effect observed in children < 1 year of age. In addition, observational data suggest that infections such as skin and soft tissue infections, rheumatic heart disease, acute respiratory illness, diarrheal illness, and malaria may all be treated by azithromycin and thus incidentally impacted by MDA-azithromycin. However, the mechanism by which MDA-azithromycin reduces childhood mortality remains unclear. Verbal autopsies performed in MDA-azithromycin childhood mortality studies have produced conflicting data and are underpowered to answer this question. In addition to benefits, there are several important risks associated with MDA-azithromycin. Direct adverse effects potentially resulting from MDA-azithromycin include gastrointestinal side effects, idiopathic hypertrophic pyloric stenosis, cardiovascular side effects, and increase in chronic diseases such as asthma and obesity. Antibacterial resistance is also a risk associated with MDA-azithromycin and has been reported for both gram-positive and enteric organisms. Further, there is the risk for cross-resistance with other antibacterial agents, especially clindamycin. Conclusions Evidence shows that MDA-azithromycin programs may be beneficial for reducing trachoma, yaws, and mortality in children < 5 years of age in certain under-resourced settings. However, there are significant potential risks that need to be considered when deciding how, when, and where to implement these programs. Robust systems to monitor benefits as well as adverse effects and antibacterial resistance are warranted in communities where MDA-azithromycin programs are implemented. Graphical Abstract

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Mass drug administration of antibacterials: weighing the evidence regarding benefits and risks

2022

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“…Two other reviews investigated the safety of AZI in children and neonates. The results showed that the safety of different dosage regimens for different indications was variable and the dose was associated with the risk of AEs 40,41 . The development of antibiotic resistance is a concern in childhood asthma using AZI.…”

Section: Discussionmentioning

confidence: 99%

The efficacy and safety of azithromycin in treatment for childhood asthma: A systematic review and meta‐analysis

Pan

Liu

Luo

et al. 2021

Pediatric Pulmonology

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Background Azithromycin (AZI) is increasingly used for childhood asthma despite limited and inconsistent data. We aimed to evaluate the efficacy and safety of AZI in childhood asthma. Methods We searched seven databases to include randomized controlled trials (RCTs) of AZI in the treatment of childhood asthma. Four reviewers independently screened the records. Risk of Bias 2 was used to assess the quality of RCTs. Risk ratios with 95% confidence interval (CI) from dichotomous outcomes, and mean difference (MD) with 95% CI from continuous outcomes were pooled. Results We included 19 eligible reports from 17 studies. The prevalence of exacerbations in AZI + budesonide (BUD) + β2 agonist (BA) group was lower than BUD + BA group (four [13%] vs. 19 [63%], p < 0.05) in 6– 14 years old children with chronic persistent asthma. AZI plus antiasthma drugs (AADs) could improve the posttreatment childhood asthma control test score (MD = 2.97; 95% CI, 2.39–3.54) compared to AADs alone in children with chronic persistent asthma. AZI plus AADs could improve posttreatment forced expiratory volume in 1 s of predicted value/forced vital capacity % (MD = 10.24%; 95% CI, 6.44%–14.03%) and posttreatment peak expiratory flow % of predicted value (MD = 7.00%; 95% CI, 2.53%–11.47%) compared to AADs alone in children with chronic persistent asthma. The most common adverse reactions of AZI combined with other drugs were gastrointestinal reactions. Conclusions AZI may be beneficial in improving some clinical symptoms and lung functions in older asthma children (over 6 years old) with persistent asthma. But it still requires further research.

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“…In a study (22), the author pointed out that the mediumdosage group (10-30 mg/kg/day) had more adverse events than that of low-dosage group, which implying more dosage would bring more adverse events. In the study (21), single dose 30 mg/kg and 3-day 20-mg/kg/day regimens are well-tolerated, although these new dosages are associated with more adverse effects.…”

Section: Discussionmentioning

confidence: 99%

Safety of azithromycin in pediatric infectious diseases: a clinical systematic review and meta-analysis

Wang

2021

Transl Pediatr

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Background: Azithromycin is a second-generation macrolide antibiotic which can be used in the treatment of diseases caused by sensitive bacterial infections. This article aimed to investigate the safety of azithromycin in the treatment of infectious diseases in children by meta-analysis.Methods: PubMed, Embase, and Cochrane were selected as the search database platforms. Randomized controlled trials (RCTs) published after 2010 were searched using the following keywords: "azithromycin", "children", "adverse event", "intravenous event", and "oral". Included studies were all clinical trials of azithromycin in the treatment of pediatric diseases. After inclusion/exclusion criteria screening and bias risk assessment, data were extracted from the included studies. RevMan 5.3.5 software was used for statistical analysis to obtain both forest and funnel plots.Results: A total of nine articles involving 3,597 pediatric patients were included in this study. The results of meta-analysis showed that the nine articles exhibited statistical heterogeneity (I 2 =70%; P=0.001), and thus, a random-effects model was used. The obtained statistic was [odds ratio (OR) =0.65; 95% confidence interval (CI): (0.43, 0.97)], the statistical effect value was Z=2.10, P=0.04, and the difference was statistically significant. After excluding one article, the remaining eight articles showed homogeneity (I 2 =12%; P=0.34).So, using fixed-effects model analysis, the statistic was [OR =0.79; 95% CI: (0.67, 0.94)], and the effect size value was Z=2.73, P=0.006. Discussion: Compared with other antibiotics, the clinical safety of azithromycin is relatively good, but care should be taken when the dosage is high in treating some disease.

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Safety of azithromycin in pediatrics: a systematic review and meta-analysis

Cited by 20 publications

References 46 publications

Mass drug administration of antibacterials: weighing the evidence regarding benefits and risks

Mass drug administration of antibacterials: weighing the evidence regarding benefits and risks

The efficacy and safety of azithromycin in treatment for childhood asthma: A systematic review and meta‐analysis

Safety of azithromycin in pediatric infectious diseases: a clinical systematic review and meta-analysis

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