{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T18:11:54Z","timestamp":1777486314449,"version":"3.51.4"},"reference-count":34,"publisher":"Public Library of Science (PLoS)","issue":"9","license":[{"start":{"date-parts":[[2025,9,29]],"date-time":"2025-09-29T00:00:00Z","timestamp":1759104000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Background<\/jats:title>\n<jats:p>Ischemic colitis (IC) is a serious but underrecognized complication potentially associated with bowel preparation. While previous studies have reported sporadic cases, the true frequency and drug-specific associations remain unclear. This study evaluates the association between oral bowel cleansers and IC using real-world pharmacovigilance data.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>We conducted a disproportionality analysis using 20 years of data (2004\u20132024) from the FDA Adverse Event Reporting System (FAERS). IC cases linked to bisacodyl, polyethylene glycol (PEG), and oral sulfate solution (OSS) were identified. Multivariate logistic regression was applied to explore factors associated with IC and serious clinical outcomes.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results<\/jats:title>\n<jats:p>Among 43,958 adverse event reports related to bowel cleansers, 75 cases of IC were identified. Bisacodyl showed the strongest disproportionality signal for IC (reporting odds ratio (ROR) = 237.25), with a reporting proportion of 7.9%, followed by PEG (ROR\u2009=\u20092.18) and OSS (ROR\u2009=\u20093.64). Older age (\u226570 years) and cardiovascular comorbidities were associated with more severe outcomes, such as hospitalization and death. Notably, reports of IC associated with PEG included six fatal and three life-threatening events.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusions<\/jats:title>\n<jats:p>To our knowledge, this is one of the largest pharmacovigilance analyses exploring ischemic colitis associated with bowel preparation agents. The findings raise concerns about the presumed safety of PEG and reveal a strong disproportionality signal for bisacodyl. These results highlight the need for individualized bowel preparation strategies, especially in elderly patients with comorbidities.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0332345","type":"journal-article","created":{"date-parts":[[2025,9,29]],"date-time":"2025-09-29T17:24:00Z","timestamp":1759166640000},"page":"e0332345","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":4,"title":["Oral bowel cleansers and ischemic colitis risk: A real-world disproportionality 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A review of bowel preparation for colonoscopy","volume":"40","author":"JM Haydel","year":"2024","journal-title":"Curr Opin Gastroenterol"},{"issue":"5","key":"pone.0332345.ref020","doi-asserted-by":"crossref","first-page":"448","DOI":"10.1002\/ueg2.12386","article-title":"Efficacy of different bowel preparation regimen volumes for colorectal cancer screening and compliance with European Society of Gastrointestinal Endoscopy performance measures","volume":"11","author":"F Theunissen","year":"2023","journal-title":"United European Gastroenterol J"},{"issue":"6","key":"pone.0332345.ref021","doi-asserted-by":"crossref","first-page":"28","DOI":"10.1007\/s11894-020-00764-4","article-title":"Bowel preparation for colonoscopy in 2020: a look at the past, present, and future","volume":"22","author":"VO Millien","year":"2020","journal-title":"Curr Gastroenterol Rep"},{"issue":"1","key":"pone.0332345.ref022","doi-asserted-by":"crossref","first-page":"424","DOI":"10.1186\/s12876-022-02497-2","article-title":"Bowel preparation using 2-L split-dose polyethylene glycol regimen plus lubiprostone versus 4-L split-dose polyethylene glycol regimen: a randomized controlled trial","volume":"22","author":"A Sirinawasatien","year":"2022","journal-title":"BMC Gastroenterol"},{"issue":"8","key":"pone.0332345.ref023","doi-asserted-by":"crossref","first-page":"1113","DOI":"10.1111\/j.1365-2036.2007.03459.x","article-title":"Clinical trial: an efficacy evaluation of reduced bisacodyl given as part of a polyethylene glycol electrolyte solution preparation prior to colonoscopy","volume":"26","author":"JA DiPalma","year":"2007","journal-title":"Aliment Pharmacol Ther"},{"issue":"6","key":"pone.0332345.ref024","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2018-021892","article-title":"Comparative safety of bowel cleansers: protocol for a systematic review and network meta-analysis","volume":"8","author":"P Barbeau","year":"2018","journal-title":"BMJ Open"},{"key":"pone.0332345.ref025","unstructured":"Sadeghi A, Farahani Z, Mohammad Reza P, Kazemi S, Negin J. Post colonoscopy ischemic colitis: a case and literature review. 2017;22:13."},{"issue":"6","key":"pone.0332345.ref026","doi-asserted-by":"crossref","first-page":"710","DOI":"10.1111\/den.12489","article-title":"Ischemic colitis after routine colonoscopy","volume":"27","author":"H Omar","year":"2015","journal-title":"Dig Endosc"},{"issue":"1","key":"pone.0332345.ref027","doi-asserted-by":"crossref","first-page":"83","DOI":"10.1007\/s00384-012-1588-2","article-title":"A pilot study using reduced-volume oral sulfate solution as a preparation for colonoscopy among a Japanese population","volume":"28","author":"H Aihara","year":"2013","journal-title":"Int J Colorectal Dis"},{"issue":"9","key":"pone.0332345.ref028","doi-asserted-by":"crossref","first-page":"2275","DOI":"10.1038\/ajg.2009.389","article-title":"A randomized clinical study evaluating the safety and efficacy of a new, reduced-volume, oral sulfate colon-cleansing preparation for colonoscopy","volume":"104","author":"JA Di Palma","year":"2009","journal-title":"Am J Gastroenterol"},{"issue":"10","key":"pone.0332345.ref029","doi-asserted-by":"crossref","first-page":"2993","DOI":"10.1007\/s10620-016-4214-2","article-title":"A comparative study of treatment-emergent adverse events following use of common bowel preparations among a colonoscopy screening population: results from a Post-Marketing Observational Study","volume":"61","author":"K Anastassopoulos","year":"2016","journal-title":"Dig Dis Sci"},{"issue":"4","key":"pone.0332345.ref030","doi-asserted-by":"crossref","first-page":"216","DOI":"10.4166\/kjg.2020.75.4.216","article-title":"Ischemic colitis associated with low-volume oral sulfate solution for bowel preparation","volume":"75","author":"JW Chung","year":"2020","journal-title":"Korean J Gastroenterol"},{"issue":"8","key":"pone.0332345.ref031","doi-asserted-by":"crossref","first-page":"1765","DOI":"10.1111\/j.1572-0241.2007.01260.x","article-title":"Pharmacologically mediated colon ischemia","volume":"102","author":"DJ Hass","year":"2007","journal-title":"Am J Gastroenterol"},{"key":"pone.0332345.ref032","doi-asserted-by":"crossref","first-page":"713521","DOI":"10.1155\/2008\/713521","article-title":"Bowel preparation for colonoscopy with sodium phosphate solution versus polyethylene glycol-based lavage: a multicenter trial","volume":"2008","author":"S Schanz","year":"2008","journal-title":"Diagn Ther Endosc"},{"issue":"10","key":"pone.0332345.ref033","doi-asserted-by":"crossref","first-page":"1412","DOI":"10.1093\/eurjpc\/zwac033","article-title":"Cardiovascular disease in the elderly: proceedings of the European Society of Cardiology-Cardiovascular Round Table","volume":"29","author":"M Lettino","year":"2022","journal-title":"Eur J Prev Cardiol"},{"issue":"1","key":"pone.0332345.ref034","doi-asserted-by":"crossref","first-page":"340","DOI":"10.1177\/0300060516684276","article-title":"Seasonal variation in occurrence of ischemic colitis: a retrospective study","volume":"45","author":"S Yamanouchi","year":"2017","journal-title":"J Int Med Res"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0332345","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,29]],"date-time":"2025-09-29T17:24:11Z","timestamp":1759166651000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0332345"}},"subtitle":[],"editor":[{"given":"Chih-Wei","family":"Tseng","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2025,9,29]]},"references-count":34,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2025,9,29]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0332345","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,29]]}}}