# Glaxo, U.S. Regulators Meet to Discuss Bowel Drug



## Jeffrey Roberts (Apr 15, 1987)

http://dailynews.yahoo.com/h/nm/20001113/s..._drug_dc_2.html Monday November 13 12:16 PM ET Glaxo, U.S. Regulators Meet to Discuss Bowel Drug 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 The consumer group Public Citizen has called for the drug to be withdrawn from the U.S. market.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.


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## Jeffrey Roberts (Apr 15, 1987)

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.


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## JeanG (Oct 20, 1999)

Thanks, Jeff. It will be interesting to see what comes of this. After listening to the people on the BB who have been helped by Lotronex, my feeling is they should not withdraw it, but emphasize to the doctors that it is not to be given to patients who experience constipation.JeanG


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## Jeffrey Roberts (Apr 15, 1987)

http://biz.yahoo.com/rf/001113/n13397552_2.html Monday November 13, 5:56 pm Eastern TimeGlaxo, U.S. regulators meet to discuss bowel drug(UPDATE: adds FDA comment para 7; updates stock price)NEW YORK, Nov 13 (Reuters) - Glaxo Wellcome Plc (quote from Yahoo! UK & Ireland: GLXO.L)(quote from Yahoo! UK & Ireland: GLXO.L) said it was meeting with the U.S. Food and DrugAdministration on Monday to discuss Lotronex, its recently approved treatment for irritablebowel syndrome 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 (FDA) in August toughened the drug's warning label. The drug was approved inFebruary 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 allof the data that we see on the drug and we're trying to make the best decisions that we can to ensure the prescribers andpatients know as much about the profile as they can,'' she told Reuters.An FDA spokesman said late on Monday there had been no change in the status of Lotronex. The spokesman said theagency does not comment publicly about private meetings with drug makers.Last month, FDA officials said they were evaluating how many serious adverse events may be related to Lotronex.The consumer group Public Citizen has called for the drug to be withdrawn from the U.S. market. A Glaxo spokeswomanon Monday said the FDA must look at that request as part of its discussions of the drug.Glaxo said Monday's meeting was 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 useand its potential unexpected adverse events,'' DuBose said.


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## Guest (Nov 14, 2000)

I totally agree with the Big C with this drug. I was in phase II trials for it back in 1997 and went from uncontrolled D to totally locked bowels. Anyone taking this should really be careful.


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## JuliaNYC (Apr 20, 2000)

Thanks, Jeff, for keeping us informed. As one of the thousands of women who has been helped by Lotronex, I am very much hoping that it will remain on the market. In fact I don't even want to think about what will happen to me if it doesn't. I recently wrote to FDA Commissioner Henney, because I don't see anything in the many media reports that remotely speaks to the interests of those of us who have been helped. All of that said, I cannot emphasize enough how inportant it is to stay in close contact with one's prescribing doctor and report any unusual symptoms immediately.


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