Lotronex (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, 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Lotronex was voluntarily withdrawn by GSK in November 2000 when the company and the FDA were unable to agree on a Risk Management Plan that would guide appropriate use of Lotronex without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.