# Lotronexï¿½ Tablets now available



## Jeffrey Roberts (Apr 15, 1987)

http://www.gsk.com/press_archive/press_11202002.htm Lotronexï¿½ Tablets now available for women with severe diarrhea-predominant irritable bowel syndrome Research Triangle Park, NC, November 20, 2002 - 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."We're entering a new era for pharmaceuticals in the U.S.," said Peter Traber, M.D. Senior Vice President and Chief Medical Officer at GlaxoSmithKline. "The industry, the Food and Drug Administration, 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 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 1,000 developed ischemic colitis over six months.Irritable bowel syndrome is a chronic, recurring condition that affects an estimated 18.5 million Americans, approximately 67% (12.4 M) of whom are women. Although the cause is currently unknown, IBS is characterized by multiple symptoms that include chronic or recurrent abdominal pain and discomfort together with irregular bowel function, such as diarrhea, constipation or alternating diarrhea and constipation. Approximately 30% of women with IBS have diarrhea-predominant IBS (3.7 million). Lotronex is indicated for women with severe diarrhea predominant IBS and the severe form of IBS is thought to affect up to 5% of this population.Lotronex 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. Now, Lotronex becomes available to patients today.London-based GlaxoSmithKline, with U.S. headquarters in Research Triangle Park, NC, and Philadelphia, is one of the world's leading research-based pharmaceutical and healthcare companies.Enquiries: GlaxoSmithKline Ramona DuBose (919) 483-2839 Updated November 20, 2002 - ï¿½ 2001-2002 GlaxoSmithKline - All Rights Reserved


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## Jeffrey Roberts (Apr 15, 1987)

Additional InformationLotronexï¿½ (alosetron hydrochloride) Tablets will be available again to certain patients under a restricted use program. Among the elements of that program are a Risk Management Plan and Phase IV study commitments. Below are some details. For more information, contact Ramona DuBose.Risk Management PlanThe risk management plan approved by the FDA includes, among other elements:ï¿½	Updated warnings in product labeling, including a Medication Guide for patients that explains to patients what to do if they get constipated or have signs of ischemic colitis.ï¿½	A lower starting dose than previously approved.ï¿½	A Prescribing Program for Lotronex for physicians to be enrolled into, based on the acceptance of certain responsibilities.ï¿½	A Patient-Physician Agreement to signed, attesting that patients are informed about risks and benefits of using Lotronex and agree to follow directions that are elements of the plan. ï¿½	Stickers affixed on all prescriptions for Lotronex to alert pharmacists that the prescribing physician is enrolled in the Prescribing Program for Lotronex (PPL).ï¿½	Directions to prescribers for active follow-up and management of patients.ï¿½	Measures to actively monitor and evaluate the plan. Continued ResearchGSK has committed to post-marketing (Phase IV) studies that include (among other requirements):ï¿½	Randomized, double-blind, placebo-controlled studies in women with severe diarrhea-predominant IBS that would evaluate the safety and efficacy of lower doses of Lotronex and of taking Lotronex on an ï¿½as neededï¿½ basis.ï¿½	Studies to investigate the etiology of ischemic colitis and small bowel ischemia.ï¿½	A patient survey to evaluate the use of Lotronex in clincial practices called the Follow-Up Study for Lotronex. The survey is important to monitor the performance of the Prescribing Program and the way Lotronex is being used. Physicians will encourage patients to enroll by providing them with the Survey Enrollment Form. The same form also will be including in the packaging of the medication that is given to patients when they get their prescription filled.


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## Jeffrey Roberts (Apr 15, 1987)

GSK has re-launched http://www.lotronex.com with information about the Prescribing Program.


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## Jeffrey Roberts (Apr 15, 1987)

Understanding the Risks and Benefits of Lotronex: http://www.lotronex.com/download/understanding.pdf


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