title: Use and safety of azithromycin in neonates: a systematic review.
abstract: OBJECTIVE
  To identify the use and adverse drug reactions associated with azithromycin in neonates.
  
  
  METHODS
  Databases MEDLINE (1948-August 2015), EMBASE (1980-August 2015) and Pubmed (August 2015) were searched for studies on azithromycin in neonates.
  
  
  METHODS
  All studies involving neonates (<28 days old) who have received at least a single dose of azithromycin for which safety was evaluated.
  
  
  METHODS
  The primary outcome was adverse event (AE) associated with use of azithromycin. Use of azithromycin in neonates was the secondary outcome.
  
  
  RESULTS
  A total of 11 articles involving 473 neonates were identified. 371 AEs were reported. Adverse events were mainly respiratory (358/1000 neonate), neurological (273/1000 neonates) and gastrointestinal (196/1000 neonates) in origin. Azithromycin significantly reduced the risk of bronchopulmonary dysplasia (BPD) in extremely premature neonates (RR=0.83, 95% CI 0.71 to 0.98, p=0.02). There was no significant difference in the incidence of elevated liver enzymes between the azithromycin and placebo group (p=0.76). There were four cases of infantile hypertrophic pyloric stenosis (IHPS).
  
  
  CONCLUSIONS
  Azithromycin significantly reduces the risk of BPD in preterm neonates. The relationship between azithromycin and IHPS requires further investigation.
authors.affiliation: Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK.
authors.forename: Coral
authors.initials: C
authors.lastname: Smith
authors.affiliation: Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK.
authors.forename: Oluwaseun
authors.initials: O
authors.lastname: Egunsola
authors.affiliation: Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK.
authors.forename: Imti
authors.initials: I
authors.lastname: Choonara
authors.affiliation: Department of Child Health, Institute of Molecular & Experimental Medicine, Cardiff University School of Medicine, Wales Heart Research Institute, Heath Park, UK.
authors.forename: Sailesh
authors.initials: S
authors.lastname: Kotecha
authors.affiliation: Univ Paris Diderot, Sorbonne Paris Cité, Department of Paediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, Paris, France.
authors.forename: Evelyne
authors.initials: E
authors.lastname: Jacqz-Aigrain
authors.affiliation: Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK.
authors.forename: Helen
authors.initials: H
authors.lastname: Sammons
mesh_terms: D000900:Anti-Bacterial Agents / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use*; D017963:Azithromycin / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001997:Bronchopulmonary Dysplasia / Q000517:prevention & control*; D006801:Humans; D062071:Infant, Extremely Premature; D007231:Infant, Newborn; D012307:Risk Factors
chemical_list: D000900:Anti-Bacterial Agents; D017963:Azithromycin
keywords: CLINICAL PHARMACOLOGY; NEONATOLOGY