AccessMyLibrary provides FREE access to over 30 million articles from top publications available through your library.
Create a link to this page
Copy and paste this link tag into your Web page or blog:
Lotronex Tablets now available for women with severe diarrhea-predominant IBS.(irritable bowel syndrome)
2003 JAN 2 - (NewsRx.com & NewsRx.net) -- Lotronex (alosetron hydrochloride) Tablets will now be available under restricted conditions of use, which include a narrower indication for specific use in female patients with severe diarrhea-predominant irritable bowel syndrome (IBS), an extensive risk management program requiring participation of physicians, patients, and pharmacists, and several additional safety and efficacy studies.
"We're entering a new era for pharmaceuticals in the U.S.," said Peter Traber, MD, senior vice president and chief medical officer at GlaxoSmithKline. "The industry, the Food and Drug Administration (FDA), the medical profession, and patients are all recognizing our joint responsibility to understand appropriate use of medicines and find ways to successfully manage potential risks in order to reap the intended benefits."
Lotronex is to be used by women with severe diarrhea-predominant irritable bowel syndrome who have failed to respond to conventional therapy, whose IBS symptoms are chronic, and who have had other gastrointestinal medical conditions that could explain their symptoms ruled out. Symptoms that make diarrhea-predominant IBS severe are frequent and serious abdominal pain, fecal incontinence, or the uncontrolled urge to have a bowel movement, or ...
- Study in Lancet Describes Efficacy; Safety Record of Newly Approved Drug for...
- Magazine article from: Ostomy Quarterly Aukett, Linda March 22, 2000 700+ words
...predominant type of irritable bowel syndrome (IBS). Lotronex Tablets was approved...predominant type of irritable bowel syndrome," said...leader and director for Lotronex at Glaxo Wellcome. Irritable bowel syndrome is a chronic...
- Lotronex(R) Tablets Now Available for Women with Severe Diarrhea-Predominant...
- Press release article from: PR Newswire November 20, 2002 700+ words
...N.C. -- Lotronex(R) (alosetron...predominant irritable bowel syndrome (IBS...intended benefits." Lotronex is to be used...predominant irritable bowel syndrome who have...with the use of Lotronex. These events...over six months. Irritable bowel syndrome is a...
- FDA Advisory Committee Recommends Approval for Glaxo Wellcome Drug Lotronex(TM)...
- Press release article from: PR Newswire November 16, 1999 700+ words
...The investigational drug Lotronex(TM) (alosetron hydrochloride...treatment of multiple symptoms of irritable bowel syndrome (IBS), was recommended...The committee recommended Lotronex for use in women with IBS...phase III trials in which Lotronex -- a potent and selective...
- Lotronex Tablets now available for women with severe diarrhoea-predominant...
- News wire article from: Asia Africa Intelligence Wire November 20, 2002 700+ words
...NewsBase - Press Release) Lotronex (alosetron hydrochloride...diarrhoea-predominant irritable bowel syndrome (IBS), an...and efficacy studies. Lotronex is to be used by women...diarrhoea-predominant irritable bowel syndrome who have failed...
- Joint Advisory Panel to the FDA Recommends Action on Lotronex(R) For Irritable...
- Press release article from: PR Newswire April 23, 2002 700+ words
...GlaxoSmithKline (GSK) for Lotronex (alosetron HCl) in...diarrhea- predominant irritable bowel syndrome. The panel...potential options for how Lotronex could be reintroduced...requirements of the plan. Irritable bowel syndrome is a chronic...constipation. Background on Lotronex ...
- Drug for severe IBS will be reintroduced in risk program. (Restrictions in...
- Magazine article from: Family Practice News Mechcatie, Elizabeth July 15, 2002 700+ words
...application that permits marketing of Lotronex "under modified conditions of...with severe diarrhea-predominant irritable bowel syndrome. During a telephone press...have no therapeutic alternative. Lotronex is the trade name for alosetron...
- Glaxo withdraws Lotronex under pressure.(FDA pressures Glaxo Wellcome to...
- Magazine article from: Medical Marketing & Media Dickinson, James G. January 1, 2001 700+ words
...to take its controversial irritable bowel syndrome drug Lotronex direct-to-consumer as...will cease distribution of Lotronex immediately." In a talk...risk management options for Lotronex "that included restricting...
- Lotronex, serotonin inhibitors for IBS win physician support; Novartis, BMS...
- Magazine article from: Medical Marketing & Media November 1, 2000 700+ words
...attributes of much-maligned Lotronex (alosetron) indicated for a selected group of irritable bowel syndrome (IBS) patients...October 16. Results with Lotronex and other as yet unreleased...and new treatments. Lotronex, the first 5-HT3 receptor...
- Glaxo Wellcome Withdraws Its Treatment for IBS From Market.(Glaxo withdraws...
- Magazine article from: Chain Drug Review December 11, 2000 700+ words
...pulled its controversial drug Lotronex from the U.S. market and...year ago as a treatment for irritable bowel syndrome (IBS), an abnormality...time that the agency approved Lotronex it warned of its potential...the possible side effects of Lotronex, it says it is complying...
- Drug for irritable bowel syndrome taken off the market.(Lotronex)(News)
- Magazine article from: British Medical Journal Charatan, Fred December 9, 2000 700+ words
...Alosetron hydrochloride (Lotronex), a prescription drag...GlaxoWellcome, and used to treat irritable bowel syndrome in women, has...diarrhoea predominant form of irritable bowel syndrome. Last August...and placebo in treating irritable bowel syndrome. Dr Wolfe said...
Source: HighBeam Research, Lotronex Tablets now available for women with severe...