# Reuters: Controversial Glaxo bowel drug may make comeback



## Jeffrey Roberts (Apr 15, 1987)

http://biz.yahoo.com/rf/010517/l1641998.html Thursday May 17, 7:01 pm Eastern TimeControversial Glaxo bowel drug may make comebackLONDON, May 18 (Reuters) - U.S. regulators may be about to let GlaxoSmithKline Plc's (quote from Yahoo! UK & Ireland: GSK.L) controversial bowel drug Lotronex back on the market, after its withdrawal last year following five deaths, a top medical journal said on Friday.The Lancet said a Food and Drug Administration advisory committee meeting was planned for June or July to consider reintroducing the medicine as a treatment for irritable bowel syndrome. The drugmaker confirmed discussions were continuing with the FDA but declined to comment on the timing of any decision.``Both the FDA and ourselves are trying to find a resolution that will benefit and protect patients,'' Glaxo spokesman Martin Sutton told Reuters.Lotronex was touted as a blockbuster with potential annual sales of over $1 billion when it was launched in March 2000. But it quickly ran into controversy as reports surfaced of patients experiencing severe constipation and ischaemic colitis, a serious condition that restricts blood flow to the colon.The product was finally withdrawn from the U.S. in November and Glaxo abandoned plans to sell it in other markets.The Lancet's editor, Richard Horton, said many within the drug watchdog now wanted to bring Lotronex back and he accused the FDA in an editorial of becoming ``the servant of industry'', alleging private communications with Glaxo had subverted official procedures.``We regard the editorial as misleading. There have been discussions between FDA and GlaxoSmithKline officials -- these meetings have all be conducted according to usual regulatory and industry practices,'' said Glaxo's Sutton.A spokesman at the FDA said he could not comment on the editorial but added that the agency was formulating a response to the allegations.Glaxo Chief Excecutive Jean-Pierre Garnier said in April he believed the odds were low that Lotronex would be reintroduced, because of the difficulty of identifying the small minority of patients who might be at risk.But industry analysts who have met with R&D head Tachi Yamada more recently told Reuters the company now appeared to be more optimistic about a Lotronex relaunch.U.S. consumer group Public Citizen, which campaigned vigorously for the drug's withdrawal last year, has urged regulators to resist pressure to put it back on the market, arguing that new data had reinforced the dangers.Public Citizen said in April that reports to the FDA up to the end of 2000 showed there were 141 cases of severe gastrointestinal complications in patients who took the drug -- twice as many as in early November, before it was withdrawn.Copyright ï¿½ 2001 Reuters Limited


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