{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:51:32Z","timestamp":1786978292357,"version":"build-2736575974"},"reference-count":16,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2016,12,2]],"date-time":"2016-12-02T00:00:00Z","timestamp":1480636800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2017,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Octreotide is a synthetic peptide analog of naturally occurring somatostatin. Octreotide is used off\u2010label in children &lt;6\u2009years of age for hyperinsulinism, chylothorax, and gastrointestinal bleeding. There is a lack of controlled data on efficacy or potential adverse events from this off\u2010label use.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Three pediatric hospitals participated in this study. Patients were hospitalized January 2007\u2013December 2010 and administered octreotide for congenital hyperinsulinism (CHI) at least 1\u2009day. Variables assessed included octreotide dosage, patient demographics, medical interventions, concomitant medicines, serious adverse events (SAEs) including necrotizing enterocolitis (NEC), and mortality.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The 103 patient sample had a median gestational age of 38\u2009weeks. During the study period, two patients died: one from NEC and the other from cardiomyopathy\/sepsis. There were 11 other SAEs in the 101 surviving patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This study highlights potential risks in administering octreotide off\u2010label. This study, like several other published studies, has highlighted NEC in a full\u2010term infant treated with octreotide. It is important to study the efficacy and the safety of octreotide for hyperinsulinism. In the interim, it might be prudent to prescribe octreotide in CHI neonates only in the absence of other risk factors for NEC. Copyright \u00a9 2016 John Wiley &amp; Sons, Ltd.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.4144","type":"journal-article","created":{"date-parts":[[2016,12,2]],"date-time":"2016-12-02T02:07:08Z","timestamp":1480644428000},"page":"26-31","source":"Crossref","is-referenced-by-count":57,"title":["Octreotide use and safety in infants with hyperinsulinism"],"prefix":"10.1002","volume":"26","author":[{"given":"Ann W.","family":"McMahon","sequence":"first","affiliation":[{"name":"Office of Pediatric Therapeutics Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerold T.","family":"Wharton","sequence":"additional","affiliation":[{"name":"Office of Pediatric Therapeutics Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Thornton","sequence":"additional","affiliation":[{"name":"Cook Children's Medical Center  Fort Worth TX USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diva D.","family":"De Leon","sequence":"additional","affiliation":[{"name":"Children's Hospital of Philadelphia  Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2016,12,2]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/ncpendmet0368"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1186\/1687-9856-2013-3"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3476(05)80969-2"},{"key":"e_1_2_6_5_1","unstructured":"Accessed 10\/19\/2015:http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2012\/019667s061lbl.pdf"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.earlhumdev.2015.04.008"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3476(05)80970-9"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1399-5448.2009.00547.x"},{"key":"e_1_2_6_9_1","unstructured":"Package insert: Sandostatin octreotide acetate; Manufactured by: Novartis Pharma Stein AG Stein Switzerland Distributed by: Novartis Pharmaceuticals Corporation East Hanover NJ 07936 \u00a9 Novartis T2012\u201071 March 2012."},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1159\/000365130"},{"key":"e_1_2_6_11_1","unstructured":"Accessed 10\/20\/2015:http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=310.305"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1651-2227.2000.tb00740.x"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.jp.7211135"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpedsurg.2008.02.062"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1159\/000443959"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2014-1866"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3476(05)80970-9"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fpds.4144","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.4144","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,5]],"date-time":"2023-10-05T05:40:13Z","timestamp":1696484413000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.4144"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,12,2]]},"references-count":16,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2017,1]]}},"alternative-id":["10.1002\/pds.4144"],"URL":"https:\/\/doi.org\/10.1002\/pds.4144","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,12,2]]}}}