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Cited by 181Gastrointestinal motility and disordersPharmacovigilance and Adverse Drug ReactionsAbdominal vascular conditions and treatments

Incidence of Ischemic Colitis and Serious Complications of Constipation Among Patients Using Alosetron: Systematic Review of Clinical Trials and Post-Marketing Surveillance Data

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Chang, Lin, Chey, William D., Harris, Lucinda, Olden, Kevin, Surawicz, Christina, Schoenfeld, Philip·2006·The American Journal of Gastroenterology
DOI 10.1111/j.1572-0241.2006.00459.x
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Abstract

BACKGROUND: Ischemic colitis and serious complications of constipation have been reported in association with the use of alosetron, which is approved for women with severe diarrhea-predominant IBS who have failed conventional therapies. This systematic review calculated the incidence of these adverse events in alosetron-using patients in clinical trials and post-marketing surveillance. METHODS: A panel of experts in epidemiology and functional bowel disorders reviewed clinical trial report forms and FDA MedWatch forms of each reported case of ischemic colitis or serious complications of constipation. Experts were blinded about whether patients used alosetron or placebo. Using pre-specified criteria, experts rated the likelihood of an accurate diagnosis and an association between medication use and adverse events. Cases that were not consistent with the reported diagnosis or not possibly associated with medication use were eliminated from calculation of incidence rates of adverse events. RESULTS: Pooled data from clinical trials indicate an increased rate of ischemic colitis among alosetron-using patients compared to placebo-using patients (0.15%vs 0.0%, respectively, p = 0.03), but there was no significant difference in the rate of serious complications of constipation. All (19/19) alosetron-using patients with ischemic colitis had reversible colitis without long-term sequelae. Based on post-marketing surveillance data, the post-adjudication rate of ischemic colitis is 1.1 per 1,000 patient-years of alosetron use and the rate of serious complications of constipation is 0.66 per 1,000 patient-years of alosetron use. CONCLUSION: The incidence of ischemic colitis and serious complications of constipation is very low and is rarely associated with long-term sequelae or serious morbidity.

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  • Alosetron was withdrawn from the market in 2001 due to reports of ischaemic colitis. However, it was reintroduced in the USA via a risk evaluation and mitigation strategy, at a lower dose of 0.5 mg two times per day, for women with severe IBS-D.

    “Alosetron was withdrawn from the market in 2001 due to reports of ischaemic colitis. 234 However, it was reintroduced in the USA via a risk evaluation and mitigation strategy, at a lower dose of 0.5 mg two times per day, for women with severe IBS-D.”

    From British Society of Gastroenterology guidelines on the management of irritable bowel syndrome (2021) · cites this paper as [234]

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Research works printed but not linked: 6

  1. [1]1. Forster JM, Houghton LA, Whorwell PJ. Alosetron slows colonic transit in patients with irritable bowel syndrome. Gastroenterology 1996;110:A630. [abstract]
  2. [15]15. Viramontes BE, Camilleri M, McKinzie, et al. Gender- related differences in slowing colonic by a 5-HT3 antagonist in subjects with diarrhea-predominant IBS. Am J Gastroen- terol 2001;96:2671-6.
  3. [19]19. Camilleri M, Chey WY, Mayer EA, et al. A randomized controlled trial of the serotonin type 3 antagonist alosetron in women with diarrhea-predominant IBS. Arch Intern Med 2001;161:1733-40.
  4. [20]20. Wolfe S, Chey W, Washington MK, et al. Tolerability of the 5HT3 receptor antagonist alosetron following long-term administration in female and male IBS patients. Am J Gas- troenterol 2001;96:803-11.
  5. [25]25. Singh G, Mithal A, Triadafilopoulos G. Patients with irrita- ble bowel syndrome have a high-risk of developing ischemic colitis [abstract]. Gastroenterology 2004;126:A349.
  6. [28]28. American Gastroenterological Association. The burden of gastrointestinal diseases. Bethesda, MD: AGA Press, 2001: 27-9.

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Authors
Chang, L., Chey, W. D., Harris, L., Olden, K., Surawicz, C., & Schoenfeld, P.
Affiliations
  • University of California, Los Angeles (US)
  • University of Michigan (US)
  • Mayo Clinic (US)
  • University of South Alabama (US)
  • University of Washington (US)
Corresponding author
Schoenfeld, Philip
ORCID
Venue
The American Journal of Gastroenterology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2006-05
Volume
101
Issue
5
Pages
1069-1079
ISSN
  • 0002-9270 (ISSN-L)
  • 1572-0241
DOI
10.1111/j.1572-0241.2006.00459.x
OpenAlex
W2121184314
Cited by
181
References
29
Citations by year
2026: 1 · 2025: 4 · 2024: 7 · 2023: 2 · 2022: 11 · 2021: 8 · 2020: 4 · 2019: 6 · 2018: 5 · 2017: 8 · 2016: 11 · 2015: 8 · 2014: 6 · 2013: 10 · 2012: 14
FWCI
2.24
Type
journal article
Language
en
Open access
Licence
public-domain
Locations
  • The American Journal of Gastroenterology (publishedVersion)
  • PubMed (publishedVersion)
  • Deep Blue (University of Michigan) (submittedVersion, public-domain)
Funders
  • GlaxoSmithKline
  • Novartis Pharmaceuticals Corporation
Topics
  • Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Health Sciences › Medicine › Surgery › Abdominal vascular conditions and treatments
Keywords
alosetron, ischemic colitis, adverse drug reactions, irritable bowel syndrome, diarrhea-predominant irritable bowel syndrome, drug safety, incidence, post-marketing surveillance
MeSH terms
Carbolines, Clinical Trials as Topic, Constipation, Diarrhea, Female, Gastrointestinal Agents, Humans, Male, Middle Aged, Product Surveillance, Postmarketing, Colitis, Ischemic, Irritable Bowel Syndrome

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