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GlaxoSmithKline Drug for Irritable Bowel Syndrome Makes Unprecedented Comeback.
Byline: David Ranii
Jun. 8--Lotronex, the GlaxoSmithKline drug for irritable bowel syndrome that has inspired ardent support from patients who say it changed their lives as well as withering attacks from critics who say it kills people, has made an unprecedented comeback.
Friday, the U.S. Food and Drug Administration approved a restricted marketing program for the drug, the first time the agency has ever permitted a company to sell a drug after it was withdrawn from the market because of safety concerns.
The decision is a victory for sufferers of irritable bowel syndrome who have been lobbying for Lotronex's return ever since GSK pulled it from the market in November 2000. The FDA requested the withdrawal in response to reports of five deaths and dozens of instances of serious health problems in people who took the drug.
Irritable bowel syndrome, or IBS, affects an estimated 18.5 million Americans. It causes lower abdominal pain and irregular bowel habits, including constipation and diarrhea so severe that it can disrupt every aspect of a person's life.
- Lotronex(R) Tablets Now Available for Women with Severe Diarrhea-Predominant...
- Press release article from: PR Newswire November 20, 2002 700+ words
...PARK, N.C. -- Lotronex(R) (alosetron...predominant irritable bowel syndrome (IBS), an extensive...intended benefits." Lotronex is to be used by...predominant irritable bowel syndrome who have failed...with the use of Lotronex. These events...months. Irritable bowel ...
- 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...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...
- Big brother in your medicine cabinet Lotronex was pulled from the market for...
- Newspaper article from: Daily Herald (Arlington Heights, IL) Rackl, Lorilyn May 14, 2001 700+ words
...to think about life without Lotronex. Until the tiny blue tablet...year, Fireman's irritable bowel syndrome was out of control. The 73...to you," Fireman said. "Lotronex made a total difference in...back. He has less than 25 Lotronex pills left. When Fireman...
- FDA Meeting on Lotronex Side Effects Signals New Safety Push.(Glaxo Wellcome's...
- Newspaper article from: Medical Letter on the CDC & FDA July 16, 2000 700+ words
...treatment for irritable bowel syndrome that has been on the...about the safety of Lotronex, a long-awaited...Wellcome Inc.'s Lotronex is the first new therapy...decades for irritable bowel syndrome, or IBS. The mysterious...constipation or both. Lotronex is only for women ...
- Lotronex Tablets now available for women with severe diarrhea-predominant...
- Magazine article from: Women's Health Weekly January 2, 2003 700+ words
...NewsRx.net) -- Lotronex (alosetron hydrochloride...predominant irritable bowel syndrome (IBS), an extensive...intended benefits." Lotronex is to be used by women...predominant irritable bowel syndrome who have failed to...association with the use of Lotronex. These events ...
- 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...predominant irritable bowel syndrome. The panel recommended...potential options for how Lotronex could be reintroduced...the plan. Irritable bowel syndrome is a chronic, recurring...constipation. Background on Lotronex ...
- FDA panel recommends action on Lotronex for irritable bowel syndrome.
- Newspaper article from: Biotech Week May 29, 2002 700+ words
...GlaxoSmithKline (GSK) for Lotronex (alosetron HCl) in the treatment...diarrhea-predominant irritable bowel syndrome. The panel recommended that...potential options for how Lotronex could be reintroduced. Final...benefited from treatment with Lotronex," said James B.D. Palmer...
- Glaxo withdraws Lotronex under pressure.(FDA pressures Glaxo Wellcome to...
- Magazine article from: Medical Marketing & Media Dickinson, James G. January 1, 2001 700+ words
...its controversial irritable bowel syndrome drug Lotronex direct-to-consumer as part...Wellcome will cease distribution of Lotronex immediately." In a talk paper...risk management options for Lotronex "that included restricting...
