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http://inq.philly.com/content/inquirer/200.../LOTRONEX24.htm The bowel-disorder drug was pulled due to side effects. The FDA is considering options for limited approval. By Kristin Reed BLOOMBERG NEWS LONDON - GlaxoSmithKline P.L.C. is talking with the Food and Drug Administration about ways to make Lotronex - an irritable-bowel-syndrome drug pulled from the market last year - available to patients again. The company, whose U.S. headquarters is in Philadelphia, withdrew Lotronex from the U.S. and world markets because of FDA concern about unexpected side effects. The withdrawal came less than 10 months after the agency approved the drug to treat bowel disorders. GlaxoSmithKline executives said Thursday that they were continuing to work with the FDA on potential options for Lotronex. "We're discussing ways to resolve the issues around that product," Tachi Yamada, GlaxoSmithKline's head of research and development, told a meeting of investors in London. Yamada said he had spoken to Janet Woodcock, the head of the FDA's drug evaluation division. Lotronex was considered a potential blockbuster drug when it was approved in February 2000 because it offered the first hope for relief from the symptoms of irritable-bowel disorder, which causes abdominal pain and severe diarrhea or constipation. The drug was withdrawn after it was linked to more than 50 cases of ischemic colitis, a dangerous intestinal condition marked by pain and rectal bleeding. FDA officials said they were looking at the "full range" of possible options for Lotronex. Those might include allowing the company to sell or provide the drug to a limited number of patients as part of a new research initiative, permitting restricted distribution of the drug so that it would be prescribed only for patients with more serious disease, or making it available under standard FDA rules for new drugs. "We are looking at the full spectrum of options, examining the pros and cons, but the FDA doesn't have a position on what is the best option," FDA spokesman Jason Brodsky said. "I wouldn't want to speculate on what the company would or wouldn't have to do." GlaxoSmithKline pulled the drug at the FDA's request in November, after more than five months of negotiating with the agency to keep the drug on pharmacy shelves. FDA officials said at the time that they had offered GlaxoSmithKline officials the chance to market the drug to a restricted group of patients. The company rejected the option, and instead withdrew the drug completely, FDA officials said. About 1,500 people - more than 1 percent of the 100,000 who used Lotronex - contacted the agency to protest the drug's withdrawal in the two weeks after the drug was taken off the market, an FDA spokesman said in December.
 
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