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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 It was withdrawn from the market in 2000 owing to the occurrence of serious life-threatening gastrointestinal adverse effects, but was reintroduced in 2002 with availability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Alosetron was withdrawn in 2000 following the association of alosetron with serious life-threatening gastrointestinal adverse effects.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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Return of Lotronex? - Brand Watch - FDA plans advisory committee
From Drug Store News, 2/18/02 by James Frederick

In response to irritable bowel syndrome patients and activists who want Lotronex (aloscetron HCI) to return to the market, the FDA will convene an advisory committee meeting April 23. GlaxoSmithKline voluntarily withdrew Lotronex from the market Nov. 28, 2000, after reports of serious and fatal gastrointestinal events.

"We recognize that for some patients with debilitating IBS, Lotronex has a positive effect," a Jan. 23 "Dear Patient" letter from the FDA's Center for Drug Education and Research noted. "However, we must address the unique circumstances of two distinct groups of IBS patients, former Lotronex users with severe disease that responded favorably to the drug and IBS patients not previously treated with Lotronex."

Lotronex was first launched in February 2000 and achieved sales of $44 million by September 2000.

COPYRIGHT 2002 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2002 Gale Group

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