# US FDA sets April 23 meeting on Glaxo's Lotronex



## Jeffrey Roberts (Apr 15, 1987)

http://biz.yahoo.com/rf/020114/n14210783_1.html Monday January 14, 6:03 pm Eastern TimeUS FDA sets April 23 meeting on Glaxo's LotronexBy Lisa RichwineWASHINGTON, Jan 14 (Reuters) - U.S. advisers will meet in April to discuss GlaxoSmithKline Plc's (quote from Yahoo! UK & Ireland: GSK.L) irritable bowel treatment Lotronex, a drug pulled from the market in 2000 over safety concerns, regulators announced on Monday.The Food and Drug Administration has scheduled a joint meeting of an advisory committee on gastrointestinal drugs and a newly formed panel on drug safety for April 23 to discuss ``risk management'' of Lotronex, FDA spokesman Jason Brodsky said. He said he could not provide any additional details.Patients with irritable bowel have lobbied the FDA to bring the drug back, arguing it is safe if dispensed properly.GlaxoSmithKline spokeswoman Ramona DuBose said only that the London-based company was continuing discussions that began a year ago with the FDA over Lotronex.The company withdrew the drug from the U.S. market in November 2000 after reports of serious intestinal problems and deaths in patients taking Lotronex. At the time, the FDA said three deaths were possibly linked to the drug.GlaxoSmithKline Chief Executive Jean-Pierre Garnier told Reuters in an interview last month that his company was in talks with the FDA about possibly reviving the drug with restrictions.Lotronex initially was touted as a potential billion-dollar-a-year product, but Garnier said it would not be a big moneymaker if it returns.``It's not going to be a major event for GlaxoSmithKline one way or the other, because if we were to put it back on the market it would be under very cautious conditions,'' he said.Irritable bowel syndrome affects millions of Americans, mostly women, and available treatments offer limited relief. The disorder can cause disabling bouts of constipation, diarrhea, abdominal pain and bloating.Lotronex had been approved for treating women whose main symptom is diarrhea.Consumer group Public Citizen has urged the FDA to keep Lotronex off the market, saying it is impossible to predict which patients are at risk for ischemic colitis, a potentially serious condition that restricts blood flow to the colon. Copyright ï¿½ 2002 Yahoo! Inc. All rights reserved.Copyright ï¿½ 2002 Reuters Limited. All rights reserved.


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## Jeffrey Roberts (Apr 15, 1987)

Here are some additional details about the FDA Advisory meeting on April 23, 2002.The meeting has been assigned docket #12538 and #12539.It will occur at:Holiday Inn Select8120 Wisconsin AvenueBETHESDA, MD 20814Local Phone: 1-301-6522000Reservations: 18778883001The meeting runs from 8am-5pm. Public statements are slated to be from 11:30am-12:30pm.An indication of interest to be on the agenda must be sent to the FDA by April 15.The agenda will be available 24-hours prior to the meeting.When available, the agenda can be found at: http://www.fda.gov/ohrms/dockets/ac/acmenu.htm


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## LotronexLover (Jan 10, 2001)

Happy Birthday to me!!!!!! (4/23/72)Jeff, can anyone attend? Or behind closed doors? Are these the same docket #'s from 6 months or so ago?


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## Lisa K (Jan 2, 1999)

Happy Birthday LotronexLover!I sure hope your birthday will bring lotronex back to all of us







Jeff, Thank you for this vital information, I am very much interested in attending this DC meeting. Will respond to your other posting for attendant listing. Take care all, Lisa K


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## Kitty Kat (Jun 26, 2001)

Happy Birtday to me, too. and you too, Lotronex Lover!! Unlike you, I'm 54!! Wanna trade? We got back from Cancun last nite--I switched back from Zofran to the last of my Lotronex for the trip--didn't want to go due to fear of diarrhea--the Lotronex worked like a charm--It was wonderful!! Of course, I watched what I ate, but did so well, it gave me more resolve than ever to try to help in any way I can to get this back on the market. I took the Zofran today, and have been MISERABLE--lots of BM's, gas, some lower abd pain--sort of what I had when I first started the Zofran. I will e-mail any body and everybody and give them my opinions. I am about 8 hrs from Bethesda, so I will be unable to attend, but I would give such a passionate plea to get that back. I find the solution easy--no BM, no pill that day. If you have a BM, take the pill--don't just take it every day, 2x day, without going to the BR!! You have to be smart about it, and it works for the majority of us. Thanks for all the work you guys do, I for sure appreciate it. Good luck. I also got the e-mail. Kitty


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