{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T00:07:31Z","timestamp":1784592451731,"version":"3.55.0"},"reference-count":30,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2018,3,25]],"date-time":"2018-03-25T00:00:00Z","timestamp":1521936000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["1072137"],"award-info":[{"award-number":["1072137"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Drug Safety"],"published-print":{"date-parts":[[2018,4]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>The rapid increase in prescribing and use of opioids for noncancer pain has coincided with an increase in opioid-related adverse drug events (ADEs). The objective of our study was to describe ADEs related to tapentadol and oxycodone\/naloxone spontaneously reported to the Australian Therapeutic Goods Administration (TGA).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Public case detail reports for tapentadol (September 2013\u2013March 2017) and oxycodone\/naloxone (April 2011\u2013March 2017) were sourced from the TGA. The total number of public case detail reports for tapentadol were 104 and 249 for oxycodone\/naloxone. Demographic characteristics of patients, concomitant medications, causality assessment and outcome were described for each opioid according to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The most prevalent ADEs for tapentadol were nervous system disorders ( n = 52, 50%), psychiatric ( n = 34, 32.7%), gastrointestinal ( n = 18, 17.3%), and general disorders and administration site conditions ( n = 21, 20.2%). Sixteen (23.2%) of 69 nervous system disorders reaction terms were consistent with serotonin syndrome of which 14 (87.5%) involved documented coadministration with another serotonergic medication. The most prevalent ADEs for oxycodone\/naloxone were psychiatric disorders ( n = 78, 31.3%), gastrointestinal ( n = 73, 29.3%), general disorders and administration site conditions ( n = 87, 35%), and nervous system disorders ( n = 62, 24.9%). There were 40 (16%) public case detail reports for oxycodone\/naloxone with the MedDRA reaction terms \u2018drug withdrawal syndrome\u2019 and \u2018withdrawal syndrome\u2019.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>The profiles of spontaneous ADE reports for tapentadol and oxycodone\/naloxone are largely consistent with their premarketing randomized controlled studies and profiles of opioids in general. Further research into the risk of serotonin syndrome with tapentadol use is warranted. The ADEs suggest clinicians should be cautious when switching patients to oxycodone\/naloxone from other opioids.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/2042098618760939","type":"journal-article","created":{"date-parts":[[2018,3,26]],"date-time":"2018-03-26T02:03:00Z","timestamp":1522029780000},"page":"197-205","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":12,"title":["Spontaneously reported adverse drug events related to tapentadol and oxycodone\/naloxone in Australia"],"prefix":"10.1177","volume":"9","author":[{"given":"Carmen","family":"Abeyaratne","sequence":"first","affiliation":[{"name":"Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, 381 Royal Parade, Parkville, Victoria, 3052, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samanta","family":"Lalic","sequence":"additional","affiliation":[{"name":"Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia"},{"name":"Pharmacy Department Austin Health, Melbourne, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. Simon","family":"Bell","sequence":"additional","affiliation":[{"name":"Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia"},{"name":"Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jenni","family":"Ilom\u00e4ki","sequence":"additional","affiliation":[{"name":"Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia"},{"name":"Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2018,3,25]]},"reference":[{"key":"bibr1-2042098618760939","doi-asserted-by":"publisher","DOI":"10.5694\/mja10.11450"},{"key":"bibr2-2042098618760939","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.12446"},{"key":"bibr3-2042098618760939","unstructured":"Australian Public Assessment Report. AusPAR: oxycodone hydrochloride\/naloxone hydrochloride (Targin). Submission no: PM-2008\u20132938\u20131, https:\/\/search.tga.gov.au\/s\/search.html?collection=tga-websites-web&query=pdf%20auspar%20auspar%20targin%20pdf (2010, accessed 12 August 2017)."},{"key":"bibr4-2042098618760939","unstructured":"Australian Public Assessment Report. AusPAR: tapentadol (Palexia SR). Submission no: PM-2009\u201302489\u20133\u20131, https:\/\/www.tga.gov.au\/sites\/default\/files\/auspar-palexia-sr.pdf (2011, accessed 25 August 2017)."},{"key":"bibr5-2042098618760939","unstructured":"Pharmaceutical Benefits Scheme. Australian statistics of medicines, http:\/\/www.pbs.gov.au\/info\/statistics\/asm\/australian-statistics-on-medicines (accessed 27 October 2017)."},{"key":"bibr6-2042098618760939","unstructured":"Pharmaceutical Benefits Scheme. Australian government department of health pharmaceutical benefits scheme, http:\/\/www.pbs.gov.au\/ (accessed 20th August 2017)."},{"key":"bibr7-2042098618760939","doi-asserted-by":"publisher","DOI":"10.1177\/2049463716657363"},{"key":"bibr8-2042098618760939","doi-asserted-by":"publisher","DOI":"10.1111\/papr.12361"},{"key":"bibr9-2042098618760939","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD011460"},{"key":"bibr10-2042098618760939","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpainsymman.2013.02.009"},{"key":"bibr11-2042098618760939","doi-asserted-by":"publisher","DOI":"10.2147\/JPR.S112418"},{"key":"bibr12-2042098618760939","doi-asserted-by":"publisher","DOI":"10.1310\/hpj5104-320"},{"key":"bibr13-2042098618760939","doi-asserted-by":"publisher","DOI":"10.1097\/PAF.0b013e3182887804"},{"key":"bibr14-2042098618760939","doi-asserted-by":"publisher","DOI":"10.1310\/hpj4807-542"},{"key":"bibr15-2042098618760939","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2013.169"},{"key":"bibr16-2042098618760939","first-page":"42","volume":"46","author":"Lau F","year":"2017","journal-title":"Aust Fam Physician"},{"key":"bibr17-2042098618760939","doi-asserted-by":"publisher","DOI":"10.3109\/15563650.2015.1060486"},{"key":"bibr18-2042098618760939","unstructured":"Aged Care Companion Online. AMH aged care companion (online). Adelaide: Australian Medicines Handbook Online. Available from: https:\/\/agedcare.amh.net.au\/ (2017, accessed 29 August 2017)"},{"key":"bibr19-2042098618760939","doi-asserted-by":"publisher","DOI":"10.18773\/austprescr.2017.018"},{"key":"bibr20-2042098618760939","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2014.12.001"},{"key":"bibr21-2042098618760939","doi-asserted-by":"publisher","DOI":"10.1111\/papr.12308"},{"key":"bibr22-2042098618760939","unstructured":"TGA eBS. Palexia\n                      \u00ae\n                      SR product information, https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2017-PI-01558\u20131 (2017, accessed 1 September 2017)."},{"key":"bibr23-2042098618760939","unstructured":"TGA eBS. Product information Targin\u00ae modified release tablets, https:\/\/www.ebs.tga.gov.au\/ebs\/picmi\/picmirepository.nsf\/pdf?OpenAgent&id=CP-2012-PI-01399\u20133 (2017, accessed 20 August 2017)."},{"key":"bibr24-2042098618760939","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3767"},{"key":"bibr25-2042098618760939","volume-title":"AAPM 32nd annual meeting","author":"Schmidt P"},{"key":"bibr26-2042098618760939","unstructured":"Food and Drug Administration. Drug Safety Communication: FDA warns about several safety issues with opioid pain medicines; requires label changes, https:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm489676.htm (2016, accessed 7 August 2017)."},{"key":"bibr27-2042098618760939","doi-asserted-by":"publisher","DOI":"10.2147\/JPR.S14842"},{"key":"bibr28-2042098618760939","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.2012.696097"},{"key":"bibr29-2042098618760939","unstructured":"NPS Radar. Oxycodone-with-naloxone controlled-release tablets (Targin) for chronic severe pain, https:\/\/www.nps.org.au\/radar\/articles\/oxycodone-with-naloxone-controlled-release-tablets-targin-for-chronic-severe-pain (accessed 24 August 2017)."},{"key":"bibr30-2042098618760939","doi-asserted-by":"publisher","DOI":"10.1016\/S1734-1140(10)70316-9"}],"container-title":["Therapeutic Advances in Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/2042098618760939","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/2042098618760939","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/2042098618760939","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T23:38:46Z","timestamp":1777592326000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/2042098618760939"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,3,25]]},"references-count":30,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2018,4]]}},"alternative-id":["10.1177\/2042098618760939"],"URL":"https:\/\/doi.org\/10.1177\/2042098618760939","relation":{},"ISSN":["2042-0986","2042-0994"],"issn-type":[{"value":"2042-0986","type":"print"},{"value":"2042-0994","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,3,25]]}}}