The Pharmaceutical Journal
Vol 268 No 7196 p597-604
4 May 2002

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Alosetron could be reintroduced

A United States Food and Drug Administration advisory panel has recommended that GlaxoSmithKline be allowed to reintroduce alosetron (Lotronex), for irritable bowel syndrome, providing there are restrictions on who can prescribe it, and patients are followed up.

Alosetron was withdrawn from the market in the US in November 2000 (PJ, 2 December 2000, p809) following reports of severe constipation and ischaemic colitis. A spokesman for GSK said that the comany and the FDA will enter into talks, but at present it is too early to conclude what will happen to Lotronex.