http://dailynews.yahoo.com/h/nm/20001113/s..._drug_dc_3.html Monday November 13 12:18 PM ET Meeting Addresses Bowel Drug Side Effects NEW YORK (Reuters) - Glaxo Wellcome Plc (GLXO.L) said it was meeting with the U.S. Food and Drug Administration (news - web sites) on Monday to discuss Lotronex, its recently approved treatment for irritable bowels which has been linked to severe constipation and other serious side effects. Lotronex has been linked to reports of a bowel condition called ischemic colitis, which restricts blood flow to the colon. The condition was identified as a possible side effect in human trials before the medication hit the market in March. U.S. regulators also have reports of severe constipation among Lotronex takers. The U.S. Food and Drug Administration in August toughened the drug's warning label. The drug was approved in February and about 300,000 people had taken it, the company reported in October. ``We are watching closely the use of Lotronex,'' said Glaxo spokeswoman Ramona DuBose. ``The FDA is monitoring it closely as well, and we are in ongoing discussions about the use, the adverse events, and all of the data that we see on the drug and we're trying to make the best decisions that we can to ensure the prescribers and patients know as much about the profile as they can,'' she told Reuters. The consumer group Public Citizen has called for the drug to be withdrawn from the U.S. market. A Glaxo spokeswoman on Monday said the FDA must look at that request as part of its discussions of the drug. FDA officials could not immediately be reached for comment Monday. Last month, the FDA said it was evaluating how many serious adverse events may be related to Lotronex. Glaxo said Monday's meeting is part of ongoing discussions regarding the drug. ``When you have a new drug on the market that's a whole new class, the FDA looks more closely at the drug and its use and its potential unexpected adverse events,'' DuBose said.