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, 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.
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