title: Use and Safety of Erythromycin and Metoclopramide in Hospitalized Infants.
abstract: OBJECTIVE
  Prokinetic medications are used in premature infants to promote motility and decrease time to full enteral feeding. Erythromycin and metoclopramide are the most commonly used prokinetic medications in the neonatal intensive care unit (NICU), but their safety profile is not well defined.
  
  
  METHODS
  We conducted a large retrospective cohort study using data from 348 NICUs managed by the Pediatrix Medical Group. All of the infants exposed to ≥1 dose of erythromycin, metoclopramide, or both, from a cohort of 8,87,910 infants discharged between 1997 and 2012 were included. We collected laboratory and clinical information while infants were exposed to erythromycin or metoclopramide and described the frequency of laboratory abnormalities and clinical adverse events (AEs).
  
  
  RESULTS
  Metoclopramide use increased from 1997 to 2005 and decreased from 2005 to 2012, whereas erythromycin use remained stable. Erythromycin use was most often associated with a diagnosis of feeding problem (40%), whereas metoclopramide was most often associated with a diagnosis of gastroesophageal reflux (59%). The most common laboratory AE during exposure to erythromycin or metoclopramide was hyperkalemia (8.6/1000 infant days on erythromycin and 11.0/1000 infant days on metoclopramide). Incidence of pyloric stenosis was greater with erythromycin than with metoclopramide (10/1095, 0.9% vs 76/19,001, 0.4%; P = 0.01), but odds were not significantly increased after adjusting for covariates (odds ratio 0.52, 95% confidence interval [CI] 0.26-1.02, P = 0.06). More infants experienced an AE while treated with metoclopramide than with erythromycin (odds ratio 1.21, 95% CI 1.03-1.43).
  
  
  CONCLUSIONS
  Metoclopramide was associated with increased risk of AEs compared with erythromycin. Studies are needed to confirm safety and effectiveness of both the drugs in infants.
authors: *Duke Clinical Research Institute †Department of Medicine, Duke University, Durham, NC ‡Pediatrix-Obstetrix Center for Research and Education, Sunrise, FL.
authors: Jessica E
authors: JE
authors: Ericson
authors: Christopher
authors: C
authors: Arnold
authors: Jomani
authors: J
authors: Cheeseman
authors: Jordan
authors: J
authors: Cho
authors: Sarah
authors: S
authors: Kaneko
authors: Ele'na
authors: E
authors: Wilson
authors: Reese H
authors: RH
authors: Clark
authors: Daniel K
authors: DK
authors: Benjamin
authors: Vivian
authors: V
authors: Chu
authors: P Brian
authors: PB
authors: Smith
authors: Christoph P
authors: CP
authors: Hornik
mesh_terms: D004750:Enteral Nutrition / Q000009:adverse effects; D004917:Erythromycin / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy; D005765:Gastrointestinal Agents / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D006947:Hyperkalemia / Q000139:chemically induced / Q000453:epidemiology; D015994:Incidence; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000188:drug therapy*; D007363:Intensive Care Units, Neonatal / Q000706:statistics & numerical data*; D008297:Male; D008787:Metoclopramide / Q000009:adverse effects* / Q000627:therapeutic use; D046248:Pyloric Stenosis, Hypertrophic / Q000139:chemically induced / Q000453:epidemiology; D012189:Retrospective Studies
chemical_list: D005765:Gastrointestinal Agents; D004917:Erythromycin; D008787:Metoclopramide