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

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Lewis JH

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

Expert Rev Gastroenterol Hepatol. 2010 Feb;4(1):13-29. doi: 10.1586/egh.09.72.

PubMed ID

20136586 [ View in PubMed

]

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-marketing experience with alosetron. Myths and misconceptions related to alosetron use, or lack thereof, are addressed to provide the reader with the evidence needed to make informed treatment decisions for their female patients with severe IBS-D.

DrugBank Data that Cites this Article

Drugs

Alosetron

Drug Targets

Drug	Target	Kind	Organism	Pharmacological Action	Actions
Alosetron	5-hydroxytryptamine receptor 3A	Protein	Humans	Yes	Antagonist	Details

Drug Interactions

Drugs	Interaction
Integrate drug-drug interactions in your software
Alosetron Fluvoxamine	The metabolism of Alosetron can be decreased when combined with Fluvoxamine.