PMID- 25968047 OWN - NLM STAT- MEDLINE DCOM- 20160223 LR - 20240407 IS - 1872-6232 (Electronic) IS - 0378-3782 (Print) IS - 0378-3782 (Linking) VI - 91 IP - 7 DP - 2015 Jul TI - Safety of octreotide in hospitalized infants. PG - 387-92 LID - S0378-3782(15)00085-7 [pii] LID - 10.1016/j.earlhumdev.2015.04.008 [doi] AB - BACKGROUND: Octreotide is used off-label in infants for treatment of chylothorax, congenital hyperinsulinism, and gastrointestinal bleeding. The safety profile of octreotide in hospitalized infants has not been described; we sought to fill this information gap. METHODS: We identified all infants exposed to at least 1 dose of octreotide from a cohort of 887,855 infants discharged from 333 neonatal intensive care units managed by the Pediatrix Medical Group between 1997 and 2012. We collected laboratory and clinical information while infants were exposed to octreotide and described the frequency of baseline diagnoses, laboratory abnormalities, and clinical adverse events (AEs). RESULTS: A total of 428 infants received 490 courses of octreotide. The diagnoses most commonly associated with octreotide use were chylothorax (50%), pleural effusion (32%), and hypoglycemia (22%). The most common laboratory AEs that occurred during exposure to octreotide were thrombocytopenia (47/1000 infant-days), hyperkalemia (21/1000 infant-days), and leukocytosis (20/1000 infant-days). Hyperglycemia occurred in 1/1000 infant-days and hypoglycemia in 3/1000 infant-days. Hypotension requiring pressors (12%) was the most common clinical AE that occurred during exposure to octreotide. Necrotizing enterocolitis was observed in 9/490 (2%) courses, and death occurred in 11 (3%) infants during octreotide administration. CONCLUSION: Relatively few AEs occurred during off-label use of octreotide in this cohort of infants. Additional studies are needed to further evaluate the safety, dosing, and efficacy of this medication in infants. CI - Copyright (c) 2015 Elsevier Ireland Ltd. All rights reserved. FAU - Testoni, Daniela AU - Testoni D AD - Duke Clinical Research Institute, Durham, NC, United States; Division of Neonatal Medicine, Escola Paulista de Medicina, Universidade Federal de Sao Paulo, Sao Paulo, Brazil. FAU - Hornik, Christoph P AU - Hornik CP AD - Duke Clinical Research Institute, Durham, NC, United States; Department of Pediatrics, Duke University, Durham, NC, United States. FAU - Neely, Megan L AU - Neely ML AD - Duke Clinical Research Institute, Durham, NC, United States; Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, United States. FAU - Yang, Qinghong AU - Yang Q AD - Duke Clinical Research Institute, Durham, NC, United States. FAU - McMahon, Ann W AU - McMahon AW AD - Office of Pediatric Therapeutics, Food and Drug Administration, Silver Spring, MD, United States. FAU - Clark, Reese H AU - Clark RH AD - Pediatrix-Obstetrix Center for Research and Education, Sunrise, FL, United States. FAU - Smith, P Brian AU - Smith PB AD - Duke Clinical Research Institute, Durham, NC, United States; Department of Pediatrics, Duke University, Durham, NC, United States. Electronic address: brian.smith@duke.edu. CN - Best Pharmaceuticals for Children Act - Pediatric Trials Network Administrative Core Committee LA - eng GR - HHSN275201000001Z/HD/NICHD NIH HHS/United States GR - K24 HD058735/HD/NICHD NIH HHS/United States GR - 1R18-FD005292-01/FD/FDA HHS/United States GR - R01 HD081044/HD/NICHD NIH HHS/United States GR - 1R01-HD081044-01/HD/NICHD NIH HHS/United States GR - DDHHS-1R18AE000028-01/AE/ASPE HHS/United States GR - UL1TR001117/TR/NCATS 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 - HHSN275201000003C/AA/NIAAA NIH HHS/United States GR - HHSN275201000001G/HD/NICHD NIH HHS/United States PT - Journal Article PT - Research Support, American Recovery and Reinvestment Act PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't PT - Research Support, U.S. Gov't, P.H.S. DEP - 20150515 PL - Ireland TA - Early Hum Dev JT - Early human development JID - 7708381 RN - 0 (Antineoplastic Agents, Hormonal) RN - RWM8CCW8GP (Octreotide) SB - IM MH - Antineoplastic Agents, Hormonal/*adverse effects/therapeutic use MH - Chylothorax/drug therapy MH - Female MH - Hospitalization MH - Humans MH - Hypoglycemia/drug therapy MH - Hypotension/*chemically induced MH - Infant MH - Infant, Newborn MH - Intensive Care Units, Neonatal MH - Male MH - Octreotide/*adverse effects/therapeutic use MH - Off-Label Use MH - Pleural Effusion/drug therapy MH - Thrombocytopenia/*chemically induced PMC - PMC4450124 MID - NIHMS685530 OTO - NOTNLM OT - Drug toxicity OT - Infant OT - Octreotide OT - Safety FIR - Benjamin, Daniel K Jr IR - Benjamin DK Jr FIR - Berezny, Katherine Y IR - Berezny KY 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 - Hill, Chapel IR - Hill C FIR - Muelenaer, Andre IR - Muelenaer A FIR - O'Shea, T Michael IR - O'Shea T FIR - Salem, Winston IR - Salem W 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- 2015/05/15 06:00 MHDA- 2016/02/26 06:00 PMCR- 2016/07/01 CRDT- 2015/05/14 06:00 PHST- 2015/03/18 00:00 [received] PHST- 2015/04/21 00:00 [accepted] PHST- 2015/05/14 06:00 [entrez] PHST- 2015/05/15 06:00 [pubmed] PHST- 2016/02/26 06:00 [medline] PHST- 2016/07/01 00:00 [pmc-release] AID - S0378-3782(15)00085-7 [pii] AID - 10.1016/j.earlhumdev.2015.04.008 [doi] PST - ppublish SO - Early Hum Dev. 2015 Jul;91(7):387-92. doi: 10.1016/j.earlhumdev.2015.04.008. Epub 2015 May 15.