Abstract
PurposeTo evaluate the toxicity of azithromycin in neonates, infants, and children.MethodsA systematic review was performed for relevant studies using Medline (Ovid), PubMed, Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, and International Pharmaceutical s. We calculated the pooled incidence of adverse drug reactions (ADRs) associated with azithromycin based on prospective studies (RCTs and prospective cohort studies) and analyzed the risk difference (RD) of ADRs between azithromycin and placebo or other antibiotics using meta-analysis of RCTs.ResultsWe included 133 studies with 4243 ADRs reported in 197,675 neonates, infants, and children who received azithromycin. The safety of azithromycin as MDA in pediatrics was poorly monitored. The main ADRs were diarrhea and vomiting. In prospective non-MDA studies, the most common toxicity was gastrointestinal ADRs (938/1967; 47.7%). The most serious toxicities were cardiac (prolonged QT or irregular heart beat) and idiopathic hypertrophic pyloric stenosis (IHPS). Compared with placebo, azithromycin did not show increased risk ADRs based on RCTs (risk difference − 0.17 to 0.07). The incidence of QT prolonged was higher in the medium-dosage group (10–30 mg/kg/day) than that of low-dosage group (≤ 10 mg/kg/day) (82.0% vs 1.2%).ConclusionThe safety of azithromycin as MDA needs further evaluation. The most common ADRs are diarrhea and vomiting. The risk of the most serious uncommon ADRs (cardiac-prolonged QT and IHPS) is unknown.
Highlights
Azithromycin is an acid-stable orally administered macrolide antimicrobial drug, structurally related to erythromycin [1]
A systematic review that evaluated the tolerance or toxicity of azithromycin in children with asthma found that gastrointestinal adverse reactions such as nausea, diarrhea, and abdominal pain were the main adverse events [11]
Another systematic review of azithromycin use in neonates highlighted the risk of infantile hypertrophic pyloric stenosis (IHPS) [12]
Summary
Azithromycin is an acid-stable orally administered macrolide antimicrobial drug, structurally related to erythromycin [1]. During the last 20 years, azithromycin mass drug administration (MDA) has been used to control trachoma with over 700 million doses of azithromycin being prescribed to children in areas of active trachoma programs [7]. Recent large trials have suggested that periodical azithromycin MDA may reduce post-neonatal infant and child mortality [8]. A systematic review that evaluated the tolerance or toxicity of azithromycin in children with asthma found that gastrointestinal adverse reactions such as nausea, diarrhea, and abdominal pain were the main adverse events [11]. Another systematic review of azithromycin use in neonates highlighted the risk of infantile hypertrophic pyloric stenosis (IHPS) [12]. This systematic review aims to evaluate the toxicity of azithromycin both as MDA or non-MDA in neonates, infants, and children from birth to 18 years old. This systematic review was proposed by the World Health Organization (WHO), as one of the systematic reviews in support of developing a guideline of azithromycin use in pediatrics to help national and international policymakers in determining the role of prophylactic azithromycin in reducing child mortality [10]
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