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Lotronex

Alosetron is a 5-HT3 antagonist used for the management of severe diarrhoea-predominant irritable bowel syndrome (IBS) in women only. It was withdrawn from the market in 2000 owing to the occurrence of serious life-threatening gastrointestinal adverse effects, but was reintroduced in 2002 with availability and use restricted. It is currently marketed by GlaxoSmithKline under the trade name Lotronex. more...

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Mode of action

Alosetron, while being a 5-HT3 antagonist like ondansetron, is not an antiemetic. Alosetron has an antagonist action on the 5-HT3 receptors of the enteric nervous system of the gastrointestinal tract.

Serious adverse effects

Alosetron was withdrawn in 2000 following the association of alosetron with serious life-threatening gastrointestinal adverse effects.

The cumulative incidence of ischaemic colitis was 2 in 1000, while serious complications arising from constipation (obstruction, perforation, impaction, toxic megacolon, secondary colonic ischaemia, death) was 1 in 1000 (GlaxoSmithKline, 2002).

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Lotronex removed from the market
From Nursing, 1/1/01

Glaxo Wellcome withdrew alosetron hydrochloride (Lotronex), a prescription drug for treating women who have irritable bowel syndrome (IBS), from the market late last November. Reports have linked the drug to ischemic colitis, severely obstructed or ruptured bowels (in some cases requiring surgery or blood transfusions), and at least five deaths.

About 15,000 people were taking Lotronex. The FDA, which approved the drug in February 2000, advises these patients to discuss treatment alternatives with their health care provider.

Copyright Springhouse Corporation Jan 2001
Provided by ProQuest Information and Learning Company. All rights Reserved

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