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.
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COPYRIGHT 2002 Gale Group
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