# Lotronex Action Group applauds pharmaceutical for making Lotronex Tablets available



## Jeffrey Roberts (Apr 15, 1987)

http://www.prweb.com/releases/2002/11/prweb50908.php Lotronex Action Group applauds pharmaceutical for making Lotronex Tablets available Thousands of patients implored both the company and the Food and Drug Administra tion to work out a plan that would allow them access to LotronexToronto, Ontario - November 20 -- Following GlaxoSmithKline's announcement today that Lotronexï¿½ (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, Jeffrey Roberts, President and Founder of the Irritable Bowel Syndrome Self Help Group, Irritable Bowel Syndrome Association and coordinator of the Lotronex Action Group, and Corey Miller, coordinator of the Lotronex Action Group jointly commented:"Patients who had successfully used Lotronex have been leading a miserable life since the drug was pulled from the market in November 2000. After years of writing and speaking to GlaxoSmithKline and the Food and Drug Administration (FDA) we are grateful to have our lives return to normal which only Lotronex had been able to provide.We again applaud both the pharmaceutical and the FDA which have come together to put the patient above all of the other issues surrounding this medicine."Background on LotronexLotronex was voluntarily withdrawn by GSK in November 2000 when the company and the FDA were unable to agree on a Risk Management Plan that would guide appropriate use of Lotronex without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 New Drug Application by GSK, which was approved by the FDA on June 7, 2002.About the Lotronex Action Group:The Lotronex Action Group was organized by members of the IBS Self Help Group (http://www.ibsgroup.org) and former Lotronex users.The Lotronex Action Group (LAG) was seeking access to the medicine Lotronex (alosetron hydrochloride). LAG ultimately seeks permanent access and safe distribution of the medicine to those diagnosed with IBS-Diarrhea.The Lotronex Action Group believes the medicine to be safe, if dispensed properly, and that the benefits of Lotronex far outweigh the potential risk for adverse side affects.About the Irritable Bowel Syndrome (IBS) Self Help Group:The IBS Self Help Group is the premier internet self help health site about Irritable Bowel Syndrome, with more than 15,000 members.The IBS Self Help Group (ibsgroup.org), formed in 1987, is in support of those who suffer from IBS, those who are looking for support for someone who has IBS, and medical professionals who want to learn moreabout IBS. The IBS website was launched in May 1995. The IBS Self Help Group website provides access to bulletin and chat boards, book list and store, medication listings, diagnosis and treatment, clinical study listings and support groups.###Contact:Irritable Bowel Syndrome (IBS) Self Help and Support GroupJeffrey Roberts, President and Founderjeffrey.roberts###ibsgroup.org416.932.3311, fax,416-932-8909www.ibsgroup.orgIrritable Bowel Syndrome Associationwww.ibsassociation.orgLotronex Action Groupwww.lotronexactiongroup.org


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## SLBEL3 (Jun 1, 2000)

so does that mean it's back now or are we still waiting on a release date?


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