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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.
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Disclaimer: This website is dedicated to providing public information regarding automobile accidents in Nevada, dangerous drug injuries, big-rig accidents, auto accidents, motorcycle accidents, personal injury, wrongful death, dog bites, nursing home negligence, insurance bad faith, product liability, amusement park accidents, toxic chemical deaths, slip and fall injuries and other legal information. None of the information on this site is intended to be formal legal advice nor the formation of a lawyer or attorney client relationship. Please contact a personal injury lawyer for information regarding your particular case. This does not guarantee, warranty or predict the outcome of your case, results are from NV & CA and include independent associated counsel. Dwight Sper is a paid spokesman for Robert Koenig. Last, please be advised that Lawyers’ Group of Nevada, Inc. is not affiliated with any public agency, the advertisements that recite results or monies collected do not constitute a guaranty, warranty or prediction regarding the outcome of your case, and said results include the efforts of Independent Associate Counsel from the states of NV and CA. In addition, the person’s depicted in the advertisements are for ad purposes only and may not be members of the firm. They are for illustrative purposes only.
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