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Lotronex tablets to be reintroduced for women with severe diarrhea-predominant IBS.(Brief Article)
2002 JUL 11 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration (FDA) approved the supplemental new drug application (sNDA) for Lotronex (alosetron hydrochloride) Tablets which provides for the reintroduction of the medicine to the marketplace under restricted conditions of use.
Lotronex Tablets will be indicated specifically for use in women with severe diarrhea-predominant irritable bowel syndrome (IBS) 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 curtailment of daily activities because of IBS.
Serious gastrointestinal events, specifically ischemic colitis and complications of constipation, have been reported in association with the use of Lotronex. These events have resulted in hospitalization, blood transfusion and/or surgery and some fatalities. In clinical trials, about three women in 1000 developed ischemic colitis over 6 months.
Lotronex was voluntarily withdrawn by GlaxoSmithKline (GSK) in November 2000 when the company and the FDA were unable to agree on a risk management plan that would guide appropriate use of Lotronex without presenting undue obstacles to patients. However, GSK and the FDA resumed discussions in January 2001, after thousands of patients who had successfully used Lotronex implored both the company and the Agency to work out a plan that would allow them access to Lotronex. These discussions culminated with the submission of the Supplemental Application. The return of a drug that was voluntarily withdrawn from the market is virtually unprecedented.
The approval comes 6 weeks after a joint FDA advisory panel of members of the GI Drugs Advisory Committee and the Drug Safety and Risk Management Subcommittee recommended that the FDA consider re-introduction of Lotronex under marketing restrictions. The committee requested that the Agency and company develop a plan to ...
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...evolving approach to drug risk management is becoming clearer...bowel syndrome drug Lotronex and the generic decongestant...warning on the label of Lotronex," Willman wrote...But the FDA's new risk management approach is not immune...based disconnects. Lotronex is the subject ...
- Lotronex Tablets now available for women with severe diarrhea-predominant IBS.
- Newspaper article from: Biotech Week January 1, 2003 700+ words
...NewsRx.net) -- Lotronex (alosetron hydrochloride...IBS), an extensive risk management program requiring participation...colitis over 6 months. Lotronex was voluntarily withdrawn...unable to agree on a risk management plan that would guide appropriate use of Lotronex without ...
- 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...IBS), an extensive risk management program requiring participation...colitis over 6 months. Lotronex was voluntarily withdrawn...unable to agree on a risk management plan that would guide appropriate use of Lotronex without ...
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...Drug Safety and Risk Management Subcommittee of...options for how Lotronex could be reintroduced...find ways to make Lotronex available to appropriate...to access." A risk management plan presented...reintroduction of Lotronex tablets, under...restrictions imposed by a ...
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...bowel syndrome drug Lotronex direct-to-consumer...part of a unique risk-management plan, Glaxo Wellcome...distribution of Lotronex immediately...presented Glaxo with new risk management options for Lotronex "that included...
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- News wire article from: Asia Africa Intelligence Wire November 20, 2002 700+ words
...IBS), an extensive Risk Management Program requiring participation...efficacy studies. Lotronex is to be used by women...symptoms ruled out. Lotronex was voluntarily withdrawn...unable to agree on a Risk Management Plan that would guide appropriate use of Lotronex without ...
- 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
...Physicians who wish to prescribe Lotronex will be enrolled in a risk management program. The Food and Drug...cder/drug/infopage/lotronex/lotronex.htm. Physicians enrolled in the risk management program will have to agree...
Source: HighBeam Research, Lotronex tablets to be reintroduced for women with severe...