{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T15:59:26Z","timestamp":1792511966286,"version":"4.5.0"},"reference-count":26,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2021,1,1]],"date-time":"2021-01-01T00:00:00Z","timestamp":1609459200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Drug Safety"],"published-print":{"date-parts":[[2021,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>The most common cause of persistent hypoglycemia in infancy is hyperinsulinemic hypoglycemia. When conservative measures fail, providers often use medications to treat persistent hypoglycemia. Diazoxide is first-line therapy for neonatal hypoglycemia and works by inhibiting insulin secretion. Diazoxide is associated with fluid retention, and less commonly with respiratory decompensation and pulmonary hypertension. Case reports documenting these severe adverse events exist in the literature, although the overall incidence, risk factors, and timing for these effects in a newborn are not clearly defined.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>We performed a retrospective chart review of all infants admitted to the neonatal intensive care unit (NICU) at Regional One Health from 1 January 2013 until 15 August 2019, who received diazoxide as a treatment for persistent hypoglycemia secondary to hyperinsulinism. Patients were stratified as either having no adverse event or having an adverse outcome to the medication. A severe adverse outcome was defined as any known major side effect of the medication, which a patient developed within 2\u2009weeks of medication initiation that led to medication discontinuation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>From our pharmacy database, we identified a total of 15 babies who received diazoxide for persistent hypoglycemia. Of these patients, eight (53%) were classified as having a complication requiring discontinuation of the medication. Six out of eight patients required intubation with mechanical ventilation and five out of eight patients developed pulmonary hypertension. All patients returned to their baseline respiratory support after drug discontinuation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>A total of 53% of our study population had an adverse outcome to diazoxide. Previous studies suggest 5% of patients may have respiratory decompensation and require ventilatory support while on diazoxide; however, 40% of our patients deteriorated and then required mechanical ventilation. Based on our data, respiratory deterioration may be more likely to occur when diazoxide is used in preterm infants, those with lower birth weight and intrauterine growth restriction.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Plain language summary<\/jats:title>\n                    <jats:p>The dangers in diazoxide Newborns could experience a transient period of low blood glucose levels soon after birth. However, some may progress to persistent low blood glucose levels that cannot be controlled with adequate glucose infusion and may require other ways of treatment. Diazoxide is the first-line drug approved by the US Food and Drug Administration (FDA) for this condition. However, certain cases have reported the development of respiratory deterioration, including increased blood pressure in lung circulation after its use. This prompted a black box warning in 2015 by the FDA. The incidence of neonatal low blood glucose levels seems to have increased and so has the use of this drug. Our study identifies 15 newborns who received diazoxide at Regional One Health neonatal intensive care unit in the past 6\u2009years and reports a significantly higher rate of adverse events in our population leading to drug discontinuation in almost 53% of our cases.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/20420986211011338","type":"journal-article","created":{"date-parts":[[2021,5,18]],"date-time":"2021-05-18T03:28:11Z","timestamp":1621308491000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":27,"title":["The danger of diazoxide in the neonatal intensive care unit"],"prefix":"10.1177","volume":"12","author":[{"given":"Jay","family":"Desai","sequence":"first","affiliation":[{"name":"Department of Pediatrics, Division of Neonatal- Perinatal Medicine, University of Tennessee Health Science Center, Memphis, TN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Logan","family":"Key","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Division of Neonatal- Perinatal Medicine, University of Tennessee Health Science Center, Memphis, TN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alyson","family":"Swindall","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Regional One Health Center, Memphis, TN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kan","family":"Gaston","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Regional One Health Center, Memphis, TN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1798-9970","authenticated-orcid":false,"given":"Ajay J.","family":"Talati","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Division of Neonatal-Perinatal Medicine, University of Tennessee Health Science Center, 853 Jefferson Ave #201, Memphis, TN 38103-3410, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2021,5,18]]},"reference":[{"key":"bibr1-20420986211011338","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM196508122730707"},{"key":"bibr2-20420986211011338","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2015.02.045"},{"key":"bibr3-20420986211011338","doi-asserted-by":"publisher","DOI":"10.1016\/j.pcl.2015.04.010"},{"key":"bibr4-20420986211011338","doi-asserted-by":"publisher","DOI":"10.1016\/j.pedn.2004.12.009"},{"key":"bibr5-20420986211011338","doi-asserted-by":"publisher","DOI":"10.1038\/s41372-018-0244-2"},{"key":"bibr6-20420986211011338","doi-asserted-by":"publisher","DOI":"10.1124\/pr.55.1.7"},{"key":"bibr7-20420986211011338","unstructured":"Proglycem (diazoxide). Silver Spring, MD: US Food and Drug Administration, 2015."},{"key":"bibr8-20420986211011338","doi-asserted-by":"publisher","DOI":"10.1186\/s13023-015-0367-x"},{"key":"bibr9-20420986211011338","doi-asserted-by":"publisher","DOI":"10.1016\/j.epsc.2019.101356"},{"key":"bibr10-20420986211011338","doi-asserted-by":"publisher","DOI":"10.1136\/archdischild-2020-319057"},{"key":"bibr11-20420986211011338","doi-asserted-by":"publisher","DOI":"10.1007\/s00246-017-1652-3"},{"key":"bibr12-20420986211011338","doi-asserted-by":"publisher","DOI":"10.2147\/DHPS.S198255"},{"key":"bibr13-20420986211011338","unstructured":"US Food and Drug Administration. FDA drug safety communication: FDA warns about a serious lung condition in infants and newborns treated with Proglycem (diazoxide). https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/fda-drug-safetycommunication-fda-warns-about-serious-lung-condition-infants-and-newborns-treated (2015, accessed 25 January 2020)."},{"key":"bibr14-20420986211011338","doi-asserted-by":"publisher","DOI":"10.1111\/cen.14096"},{"key":"bibr15-20420986211011338","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2018-01613"},{"key":"bibr16-20420986211011338","doi-asserted-by":"publisher","DOI":"10.1159\/000497458"},{"key":"bibr17-20420986211011338","doi-asserted-by":"publisher","DOI":"10.1159\/000356772"},{"key":"bibr18-20420986211011338","doi-asserted-by":"publisher","DOI":"10.1515\/jpem.2011.238"},{"key":"bibr19-20420986211011338","doi-asserted-by":"publisher","DOI":"10.1038\/s41372-018-0218-4"},{"key":"bibr20-20420986211011338","doi-asserted-by":"publisher","DOI":"10.1093\/hmg\/5.11.1809"},{"key":"bibr21-20420986211011338","doi-asserted-by":"publisher","DOI":"10.1126\/science.7716548"},{"key":"bibr22-20420986211011338","doi-asserted-by":"publisher","DOI":"10.1136\/adc.2006.095919"},{"key":"bibr23-20420986211011338","first-page":"381","volume":"9","author":"Shiu YK","year":"2003","journal-title":"Hong Kong Med J"},{"key":"bibr24-20420986211011338","doi-asserted-by":"publisher","DOI":"10.4103\/2249-4847.151174"},{"key":"bibr25-20420986211011338","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2015.03.057"},{"key":"bibr26-20420986211011338","doi-asserted-by":"publisher","DOI":"10.1055\/s-0039-3400975"}],"container-title":["Therapeutic Advances in Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/20420986211011338","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/20420986211011338","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/20420986211011338","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T23:39:42Z","timestamp":1777592382000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/20420986211011338"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,1]]},"references-count":26,"alternative-id":["10.1177\/20420986211011338"],"URL":"https:\/\/doi.org\/10.1177\/20420986211011338","relation":{},"ISSN":["2042-0986","2042-0994"],"issn-type":[{"value":"2042-0986","type":"print"},{"value":"2042-0994","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,1]]},"article-number":"20420986211011338"}}