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BMJ Open. 2015 Dec 9;5(12):e008194. doi: 10.1136/bmjopen-2015-008194.

Use and safety of azithromycin in neonates: a systematic review.

Author information

1
Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK.
2
Department of Child Health, Institute of Molecular & Experimental Medicine, Cardiff University School of Medicine, Wales Heart Research Institute, Heath Park, UK.
3
Univ Paris Diderot, Sorbonne Paris Cité, Department of Paediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, Paris, France.

Abstract

OBJECTIVES:

To identify the use and adverse drug reactions associated with azithromycin in neonates.

SETTING:

Databases MEDLINE (1948-August 2015), EMBASE (1980-August 2015) and Pubmed (August 2015) were searched for studies on azithromycin in neonates.

PARTICIPANTS:

All studies involving neonates (<28 days old) who have received at least a single dose of azithromycin for which safety was evaluated.

PRIMARY AND SECONDARY OUTCOME MEASURES:

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.

KEYWORDS:

CLINICAL PHARMACOLOGY; NEONATOLOGY

PMID:
26656010
PMCID:
PMC4679913
DOI:
10.1136/bmjopen-2015-008194
[Indexed for MEDLINE]
Free PMC Article

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