PMID- 25806675 OWN - NLM STAT- MEDLINE DCOM- 20160526 LR - 20240407 IS - 1536-4801 (Electronic) IS - 0277-2116 (Print) IS - 0277-2116 (Linking) VI - 61 IP - 3 DP - 2015 Sep TI - Use and Safety of Erythromycin and Metoclopramide in Hospitalized Infants. PG - 334-9 LID - 10.1097/MPG.0000000000000792 [doi] AB - 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. FAU - Ericson, Jessica E AU - Ericson JE AD - *Duke Clinical Research Institute daggerDepartment of Medicine, Duke University, Durham, NC double daggerPediatrix-Obstetrix Center for Research and Education, Sunrise, FL. FAU - Arnold, Christopher AU - Arnold C FAU - Cheeseman, Jomani AU - Cheeseman J FAU - Cho, Jordan AU - Cho J FAU - Kaneko, Sarah AU - Kaneko S FAU - Wilson, Ele'na AU - Wilson E FAU - Clark, Reese H AU - Clark RH FAU - Benjamin, Daniel K Jr AU - Benjamin DK Jr FAU - Chu, Vivian AU - Chu V FAU - Smith, P Brian AU - Smith PB FAU - Hornik, Christoph P AU - Hornik CP CN - Best Pharmaceuticals for Children Act-Pediatric Trials Network Administrative Core Committee LA - eng GR - HHSN275201000001Z/HD/NICHD NIH HHS/United States GR - 1R25HD076475-01/HD/NICHD NIH HHS/United States GR - K24 HD058735/HD/NICHD NIH HHS/United States GR - R01 HD081044/HD/NICHD NIH HHS/United States GR - HHSN272201500001G/AI/NIAID NIH HHS/United States GR - HHSN272201500001C/AI/NIAID NIH HHS/United States GR - R25 HD076475/HD/NICHD NIH HHS/United States GR - HHSN275201000003I/HD/NICHD NIH HHS/United States GR - R18 FD005292/FD/FDA HHS/United States GR - UL1 TR001117/TR/NCATS NIH HHS/United States GR - HHSN272201500006C/AI/NIAID NIH HHS/United States GR - HHSN275201000001G/HD/NICHD NIH HHS/United States GR - T32 HD060558/HD/NICHD NIH HHS/United States GR - HHSN275201000003C/AA/NIAAA NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural PL - United States TA - J Pediatr Gastroenterol Nutr JT - Journal of pediatric gastroenterology and nutrition JID - 8211545 RN - 0 (Gastrointestinal Agents) RN - 63937KV33D (Erythromycin) RN - L4YEB44I46 (Metoclopramide) SB - IM MH - Enteral Nutrition/adverse effects MH - Erythromycin/*adverse effects/therapeutic use MH - Female MH - Gastroesophageal Reflux/drug therapy MH - Gastrointestinal Agents/*adverse effects/therapeutic use MH - Humans MH - Hyperkalemia/chemically induced/epidemiology MH - Incidence MH - Infant, Newborn MH - Infant, Premature MH - Infant, Premature, Diseases/*drug therapy MH - Intensive Care Units, Neonatal/*statistics & numerical data MH - Male MH - Metoclopramide/*adverse effects/therapeutic use MH - Pyloric Stenosis, Hypertrophic/chemically induced/epidemiology MH - Retrospective Studies PMC - PMC4553109 MID - NIHMS673367 COIS- Conflicts of interest: The authors declare that they have no conflicts of interest to disclose. FIR - Berezny, Katherine Y IR - Berezny KY FIR - Barrett, Jeffrey IR - Barrett J FIR - Capparelli, Edmund IR - Capparelli E FIR - Cohen-Wolkowiez, Michael IR - Cohen-Wolkowiez M FIR - Kearns, Gregory L IR - Kearns GL FIR - Laughon, Matthew IR - Laughon M FIR - Muelenaer, Andre IR - Muelenaer A FIR - O'Shea, T Michael IR - O'Shea TM FIR - Paul, Ian M IR - Paul IM FIR - van den Anker, John IR - van den Anker J FIR - Wade, Kelly IR - Wade K FIR - Walsh, Thomas J IR - Walsh TJ FIR - Siegel, David IR - Siegel D FIR - Taylor-Zapata, Perdita IR - Taylor-Zapata P FIR - Zajicek, Anne IR - Zajicek A FIR - Pagan, Alice IR - Pagan A FIR - Anand, Ravinder IR - Anand R FIR - Clemons, Traci IR - Clemons T FIR - Simone, Gina IR - Simone G EDAT- 2015/03/26 06:00 MHDA- 2016/05/27 06:00 PMCR- 2016/09/01 CRDT- 2015/03/26 06:00 PHST- 2015/03/26 06:00 [entrez] PHST- 2015/03/26 06:00 [pubmed] PHST- 2016/05/27 06:00 [medline] PHST- 2016/09/01 00:00 [pmc-release] AID - 10.1097/MPG.0000000000000792 [doi] PST - ppublish SO - J Pediatr Gastroenterol Nutr. 2015 Sep;61(3):334-9. doi: 10.1097/MPG.0000000000000792.