# GlaxoSmithKline: Joint Advisory Panel to the FDA Recommends Action on Lotronex



## Jeffrey Roberts (Apr 15, 1987)

Joint Advisory Panel to the FDA Recommends Action on Lotronex® For Irritable Bowel Syndrome RESEARCH TRIANGLE PARK, N.C., April 23 /PRNewswire/ -- A joint advisory panel to the U.S. Food and Drug Administration (FDA) reviewed the elements of a supplemental New Drug Application (sNDA) submitted by GlaxoSmithKline (GSK) for Lotronex (alosetron HCl) in the treatment of women with diarrhea- predominant irritable bowel syndrome. The panel recommended that the FDA consider the possible reintroduction of the drug to the market under restrictions to be determined in discussions between the FDA and the company. Panel members from the Gastrointestinal Drugs Advisory Committee and the newly formed Drug Safety and Risk Management Subcommittee of the Pharmaceutical Science Committee discussed a broad range of potential options for how Lotronex could be reintroduced. Final details on the possible reintroduction of the medicine, and under what conditions, will be discussed by GSK and the FDA. No timeframe for decision-making has been announced. "There was compelling and impassioned testimony today from patients who have clearly benefited from treatment with Lotronex," said James B.D. Palmer, M.D., Senior Vice President of New Product Development at GlaxoSmithKline. "It is with their needs in mind that we will continue to work with the FDA to find ways to make Lotronex available to appropriate patients without creating undue barriers to access." A risk management plan presented by GSK at the meeting includes, among other elements, enhanced warnings in product labeling, of which a Medication Guide for patients is part; restricted eligibility for prescribers and patients; mandatory counseling of patients on benefits and risks; directions for active follow-up and management of patients, keyed to the potential risks of ischemic colitis and serious complications of constipation; and appropriate measures to document and evaluate plan compliance, as well as to educate prescribers, pharmacists, and patients about the requirements of the plan. Irritable bowel syndrome is a chronic, recurring condition that affects an estimated 1 in 5 Americans. Although the cause is unknown, IBS is characterized by multiple symptoms that include chronic or recurrent abdominal pain and discomfort and irregular bowel function, such as diarrhea, constipation or alternating diarrhea and constipation. Background on Lotronex Lotronex received FDA approval for marketing in the U.S. on February 9, 2000. On November 28, 2000, after substantial discussion with the FDA, GlaxoSmithKline voluntarily withdrew Lotronex from the U.S. market. Serious gastrointestinal events, some fatal, have been reported in association with the use of Lotronex. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization, blood transfusion, and/or surgery. In December, 2001, GSK filed a supplemental application seeking FDA approval to allow the reintroduction of Lotronex tablets, under modified conditions of use and with restrictions imposed by a risk management plan, for women with diarrhea-predominant IBS who have failed on conventional therapy. GlaxoSmithKline, one of the world's leading research based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer. SOURCE GlaxoSmithKline -0- 04/23/2002 /CONTACT: Ramona Dubose, +1-919-483-2839, for GlaxoSmithKline/


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## CalifCarl (Aug 24, 2001)

Jeffery is the men thing going to be a stumbling block for us men in need? I mean you men.Thanks Carla


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