Alosetron for severe diarrhea-predominant irritable bowel syndrome: safety and efficacy in perspective

Expert Review of Gastroenterology & Hepatology
James H Lewis

Abstract

Irritable bowel syndrome affects 5-10% of North Americans, with an estimated one-third having a diarrhea-predominant form. Alosetron hydrochloride (Lotronex) is a serotonin receptor type 3 antagonist approved in early 2000 for use in women with diarrhea-predominant irritable bowel syndrome (IBS-D). Initial use was widespread, but infrequent serious adverse events of ischemic colitis and severe constipation-related complications prompted alosetron's voluntary withdrawal from the US market in November 2000. Unprecedented public request prompted its reintroduction in 2002 under a Risk Management Plan, including a more restricted indication and a Prescribing Program for Lotronex. Despite these measures, the use of alosetron has been very limited since its reintroduction. Possible deterrents to its use include concerns over safety and the possible medical-legal implications raised by the Risk Management Plan. It is also possible that changes in the natural history and/or diagnosis of IBS-D have reduced the target population. Given the unique regulatory history of alosetron, these issues continue to engender controversy. This article profiles these concerns and reviews the pharmacology, clinical efficacy and safety, and post-marketin...Continue Reading

References

Feb 1, 1997·Alimentary Pharmacology & Therapeutics·M Camilleri, M G Choi
Jun 1, 1997·Alimentary Pharmacology & Therapeutics·B A HahnE Mayer
Oct 1, 1998·Journal of Clinical Gastroenterology·D A Greenwald, L J Brandt
Oct 13, 1998·Alimentary Pharmacology & Therapeutics·M DelvauxJ Frexinos
Aug 3, 1999·Alimentary Pharmacology & Therapeutics·D A Drossman
Aug 3, 1999·Alimentary Pharmacology & Therapeutics·M D Gunput
Nov 5, 1999·Liver Transplantation and Surgery : Official Publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society·R J FontanaW M Lee
Apr 8, 2000·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·J L Miller
Sep 13, 2000·Gastroenterology·I M GralnekE A Mayer
Feb 13, 2001·Gastroenterology·D FriedelR S Fisher
Mar 10, 2001·The American Journal of Gastroenterology·M E WatsonA W Mangel
Apr 18, 2001·Journal of Clinical Pharmacology·D L D'SouzaK M Koch
Apr 18, 2001·Journal of Clinical Pharmacology·D L D'SouzaK M Koch
May 2, 2001·Digestive Diseases and Sciences·D A LazarczykS C Gordon
Sep 25, 2001·The American Journal of Gastroenterology·T LemboUNKNOWN Lotronex Investigator Team
Dec 12, 2001·British Journal of Clinical Pharmacology·K M KochK E Kersey
May 4, 2002·Lancet·Michael McCarthy
May 29, 2002·Alimentary Pharmacology & Therapeutics·H B El-SeragD Bjorkman
Nov 28, 2002·Gastroenterology·UNKNOWN American Gastroenterology Association
Nov 28, 2002·Gastroenterology·Douglas A DrossmanWilliam E Whitehead
Dec 21, 2002·The American Journal of Gastroenterology·Kevin OldenUNKNOWN Lotronex Investigator Team
Jan 16, 2003·The American Journal of Gastroenterology·David J GrahamDeborah Shatin
Dec 4, 2003·The New England Journal of Medicine·Howard R Mertz
Mar 16, 2004·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·Joseph A MurrayL Joseph Melton
Apr 2, 2004·The American Journal of Gastroenterology·J Alexander ColeAlexander M Walker
Apr 6, 2004·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Viola Andresen, Stephan Hollerbach
Jun 10, 2004·Digestive Diseases and Sciences·Olaitan A AdenijiJack A Di Palma
Jun 10, 2004·Gastroenterology·George F Longstreth, Janis F Yao
Jul 3, 2004·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·William L Hasler, Philip Schoenfeld
Jul 6, 2004·The American Journal of Gastroenterology·Alexander M WalkerBruce E Sands
Jul 6, 2004·Alimentary Pharmacology & Therapeutics·K M KochK E Kersey
Jul 21, 2004·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·Kate Traynor
Aug 4, 2004·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·Anthony J LemboEric G Carter
Sep 25, 2004·Digestive Diseases and Sciences·Kevin KochKathryn E E Kersey

❮ Previous
Next ❯

Citations

Feb 7, 2012·Gastroenterology Nursing : the Official Journal of the Society of Gastroenterology Nurses and Associates·Lucinda A Harris, Margaret M Heitkemper
Feb 22, 2012·The Journal of Alternative and Complementary Medicine : Research on Paradigm, Practice, and Policy·Nathan J Rogers, Shaker A Mousa
Jan 7, 2011·Current Medical Research and Opinion·Scott Bleser
Mar 13, 2014·Alimentary Pharmacology & Therapeutics·E Shah, M Pimentel
Mar 4, 2015·The American Journal of Medicine·Gregory S Sayuk, C Prakash Gyawali
Sep 5, 2013·Therapeutic Advances in Gastroenterology·Kenneth TongLin Chang
Apr 6, 2012·The American Journal of Gastroenterology·Eli D EhrenpreisUNKNOWN FDA-Related Matters Committee of the American College of Gastroenterology
Sep 15, 2018·Neurogastroenterology and Motility : the Official Journal of the European Gastrointestinal Motility Society·Matthew D CoatesVictor Ruiz-Velasco
Jun 15, 2011·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·James H Lewis
Dec 5, 2013·Current Opinion in Endocrinology, Diabetes, and Obesity·Supriya Rao, H Christian Weber
Oct 14, 2018·The American Journal of Gastroenterology·Afrin Kamal, Mark Pimentel
Sep 1, 2018·Inflammatory Bowel Diseases·Afrin KamalBret Lashner
Sep 5, 2012·Nature Reviews. Gastroenterology & Hepatology·Stacy MeneesWilliam D Chey
Jan 12, 2021·European Journal of Internal Medicine·Christopher Tait, Gregory S Sayuk
Jan 13, 2020·Chemical Science·Xiangxiang ZengFeixiong Cheng

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.