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Lotronex (alosetron hydrochloride, a Glaxo Wellcome product) was initially approved by the FDA on February 9, 2000 for the treatment of Irritable Bowel Syndrome (IBS). IBS is a common and debilitating digestive disorder that afflicts an estimated 15% of the U.S. population, mostly women. IBS causes lower abdominal pain and discomfort and irregular bowel habits such as diarrhea or constipation. Lotronex, a potential billion- dollar-drug, was approved only for women with diarrhea predominant IBS.
Between approval and June 1, 2000 the FDA received seven reports of serious complications of constipation and reports of . These resulted in hospitalizations, and surgical procedures.
Last April the FDA warned the company about unsubstantiated claims of benefit and a sales brochure that buried important risk information.
On November 28, 2000 Glaxo announced that it would voluntarily withdraw Lotronex from the market.
AA-Accident Attorneys, P.L.C. has represented numerous victims of toxic chemical injuries, and is uniquely qualified to assist you discovering the cause of potentially latent toxic poisoning. Many toxic chemical injuries don't manifest themselves for some time after exposure, making the competent investigation of the cause of the subjective complaints extremely important.
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