{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:44:42Z","timestamp":1787013882115,"version":"build-2736575974"},"reference-count":32,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2018,1,19]],"date-time":"2018-01-19T00:00:00Z","timestamp":1516320000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2018,3]]},"abstract":"<jats:title>Summary<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Cases of pancreatitis were identified in the eluxadoline clinical development program, reflected in initial product labelling, and the subject of postmarketing reports.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To analyse postmarketing cases of eluxadoline\u2010associated pancreatitis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      We retrospectively analysed all US adverse event reports of pancreatitis associated with eluxadoline reported to the\n                      <jats:styled-content style=\"fixed-case\">FDA<\/jats:styled-content>\n                      Adverse Event Reporting System (\n                      <jats:styled-content style=\"fixed-case\">FAERS<\/jats:styled-content>\n                      ) database from May 27, 2015 through February 15, 2017.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The analysis included 119 cases of pancreatitis associated with eluxadoline; one resulted in death and 75 in hospitalisation. Sixty\u2010seven cases reported the presence (n\u00a0=\u00a012) or absence (n\u00a0=\u00a055) of the patient's gallbladder. The eluxadoline dose received in the 55 cases of patients without gallbladders was 75\u00a0mg (n\u00a0=\u00a043), 100\u00a0mg (n\u00a0=\u00a05), or not reported (n\u00a0=\u00a07). Of the 119 cases, 37 reported the patient did not abuse alcohol and 82 did not report the alcohol abuse status. The single fatal case occurred in a patient without a gallbladder who received eluxadoline 75\u00a0mg and did not abuse alcohol. Forty\u2010seven cases reported development of pancreatitis within the first or second dose of eluxadoline initiation. The median time to onset for the development of pancreatitis (n\u00a0=\u00a083) was 1\u00a0day, ranging from 1 to 56\u00a0days of continued use of eluxadoline.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      The\n                      <jats:styled-content style=\"fixed-case\">FAERS<\/jats:styled-content>\n                      cases suggest that patients with or without a gallbladder receiving eluxadoline are at risk for the development of pancreatitis. However, patients without a gallbladder, despite receiving the recommended lower dose of eluxadoline 75\u00a0mg and screening for alcohol abuse, appear to be overrepresented among patients who developed eluxadoline\u2010associated pancreatitis.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/apt.14504","type":"journal-article","created":{"date-parts":[[2018,1,19]],"date-time":"2018-01-19T01:12:39Z","timestamp":1516324359000},"page":"809-815","source":"Crossref","is-referenced-by-count":25,"title":["Postmarketing cases of eluxadoline\u2010associated pancreatitis in patients with or without a gallbladder"],"prefix":"10.1111","volume":"47","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7372-6051","authenticated-orcid":false,"given":"L.","family":"Harinstein","sequence":"first","affiliation":[{"name":"Division of Pharmacovigilance Office of Surveillance and Epidemiology FDA Center for Drug Evaluation and Research Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"Wu","sequence":"additional","affiliation":[{"name":"Division of Pharmacovigilance Office of Surveillance and Epidemiology FDA Center for Drug Evaluation and Research Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Brinker","sequence":"additional","affiliation":[{"name":"Division of Pharmacovigilance Office of Surveillance and Epidemiology FDA Center for Drug Evaluation and Research Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,1,19]]},"reference":[{"key":"e_1_2_7_2_1","volume-title":"Viberzi\u2122 (eluxadoline) [product label]"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1476-5381.2012.02068.x"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.02.033"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1440-1746.2009.06072.x"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1080\/17474124.2016.1251308"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2012.09.006"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.28.11.1500"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.1840040225"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF01308180"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2013.04.006"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1505180"},{"key":"e_1_2_7_13_1","unstructured":"U.S. Food and Drug Administration.Questions and Answers on FDA's Adverse Event Reporting System (FAERS). Available at:https:\/\/www.fda.gov\/drugs\/guidancecomplianceregulatoryinformation\/surveillance\/adversedrugeffects\/. Accessed July 21 2017."},{"key":"e_1_2_7_14_1","volume-title":"Medical dictionary for regulatory activities","author":"Maintenance and Support Services Organization [Homepage on the Internet]","year":"2013"},{"key":"e_1_2_7_15_1","unstructured":"Postmarketing reporting of adverse drug experiences.Electronic Code of Federal Regulations Title 21: Food and Drugs Part 314. Available at:https:\/\/www.ecfr.gov\/cgi-bin\/text-idx?SID=89c82c570dc9b6fdf103447f11c889f6&mc=true&node=se21.5.314_180&rgn=div8. Accessed July 21 2017."},{"key":"e_1_2_7_16_1","unstructured":"FDA Drug Safety Communication.FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder. Available at:https:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm546154.htm. Accessed June 1 2017."},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2710.2010.01177.x"},{"key":"e_1_2_7_18_1","volume-title":"Loperamide hydrochloride [product label]"},{"key":"e_1_2_7_19_1","first-page":"517414","article-title":"Loperamide\u2010induced acute pancreatitis","volume":"2013","author":"Vidarsdottir H","year":"2013","journal-title":"Case Rep Gastrointest Med"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinre.2015.06.008"},{"key":"e_1_2_7_21_1","volume-title":"MS Contin\u2122 (morphine sulfate extended\u2010release tablets) [product label]"},{"key":"e_1_2_7_22_1","volume-title":"Fentanyl citrate injection [product label]"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2001.03536.x"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2000.03213.x"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.mcg.0000173929.60115.b4"},{"key":"e_1_2_7_26_1","first-page":"CD009179","article-title":"Opioids for acute pancreatitis pain","volume":"7","author":"Basurto OX","year":"2013","journal-title":"Cochrane Database of Systematic Reviews"},{"key":"e_1_2_7_27_1","doi-asserted-by":"publisher","DOI":"10.1080\/003655200453692"},{"key":"e_1_2_7_28_1","doi-asserted-by":"publisher","DOI":"10.1159\/000076541"},{"key":"e_1_2_7_29_1","doi-asserted-by":"publisher","DOI":"10.1159\/000114852"},{"key":"e_1_2_7_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0016-5085(17)34353-6"},{"key":"e_1_2_7_31_1","doi-asserted-by":"publisher","DOI":"10.14309\/00000434-201610001-01697"},{"key":"e_1_2_7_32_1","article-title":"Risk of pancreatitis following treatment of irritable bowel syndrome with eluxadoline","author":"Gawron AJ","year":"2017","journal-title":"Clin Gastroenterol Hepatol"},{"key":"e_1_2_7_33_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2012-302779"}],"container-title":["Alimentary Pharmacology &amp; Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fapt.14504","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/apt.14504","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,10]],"date-time":"2023-09-10T03:11:19Z","timestamp":1694315479000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/apt.14504"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,1,19]]},"references-count":32,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2018,3]]}},"alternative-id":["10.1111\/apt.14504"],"URL":"https:\/\/doi.org\/10.1111\/apt.14504","archive":["Portico"],"relation":{},"ISSN":["0269-2813","1365-2036"],"issn-type":[{"value":"0269-2813","type":"print"},{"value":"1365-2036","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,1,19]]}}}