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

Linan Zeng1,2, Peipei Xu1,2,3,4, Imti Choonara5

  • 1Department of Pharmacy/Evidence-based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, 610041, China.

European Journal of Clinical Pharmacology
|July 19, 2020
PubMed

Insights

Azithromycin is generally safe for children, with common side effects like diarrhea and vomiting. However, serious cardiac events and pyloric stenosis risks remain unclear, necessitating further study.

Area of Science:

  • Pediatric Pharmacology
  • Drug Safety and Toxicology
  • Systematic Reviews and Meta-Analyses

Background:

  • Azithromycin is a widely used antibiotic in pediatric populations.
  • Understanding its safety profile, especially in vulnerable neonates, infants, and children, is crucial.
  • Concerns exist regarding potential adverse drug reactions (ADRs) with azithromycin use.

Purpose of the Study:

  • To systematically evaluate the toxicity and adverse drug reactions (ADRs) of azithromycin in neonates, infants, and children.
  • To quantify the incidence and risk of ADRs associated with azithromycin treatment.
  • To compare the risk of ADRs between azithromycin and placebo or other antibiotics.

Main Methods:

  • A comprehensive systematic review of multiple electronic databases (Medline, PubMed, Cochrane, EMBASE, CINAHL, IPA) was conducted.
  • Pooled incidence of ADRs was calculated from prospective studies (RCTs, prospective cohort studies).
  • Meta-analysis of RCTs was used to determine the risk difference (RD) of ADRs compared to placebo or other antibiotics.

Main Results:

  • 133 studies involving 197,675 pediatric patients reported 4243 ADRs.
  • Gastrointestinal issues, primarily diarrhea and vomiting, were the most frequent ADRs (47.7% in non-MDA studies).
  • Serious toxicities like cardiac events (prolonged QT) and idiopathic hypertrophic pyloric stenosis (IHPS) were identified, with higher QT prolongation incidence at medium dosages.

Conclusions:

  • Azithromycin's safety as mass drug administration (MDA) in pediatrics requires further investigation.
  • While common ADRs are gastrointestinal, the risk of serious, less common ADRs, including cardiac effects and IHPS, remains largely unknown.
  • Azithromycin did not demonstrate an increased risk of ADRs compared to placebo in RCTs, but specific serious events warrant continued monitoring.
Abstract

Keywords:
AzithromycinMeta-analysisPediatricsSafetySystematic review

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