# Reuters: Glaxo says Lotronex may return, but no blockbuster



## Jeffrey Roberts (Apr 15, 1987)

http://biz.yahoo.com/rf/011218/l18241095_1.html Tuesday December 18, 1:49 pm Eastern TimeGlaxo says Lotronex may return, but no blockbusterLONDON, Dec 18 (Reuters) - GlaxoSmithKline Plc (quote from Yahoo! UK & Ireland: GSK.L) said on Tuesday the group's controversial bowel drug Lotronex might go back on sale following its forced withdrawal last year, but it would never be a huge money spinner.``We are still discussing with the FDA (U.S. Food and Drug Administration) -- the ball is in the camp of the agency. I can't make a prognosis on what is going to happen,'' Chief Executive Jean-Pierre Garnier told Reuters in an interview.``It is 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to put it back on the market it would be under very cautious conditions,'' he added.The FDA requested the product be withdrawn in November 2000, citing three deaths as possibly linked to the drug. Since then the regulator has indicated it would consider its reintroduction if there was a way to predict which patients might be at risk.Lotronex -- initially touted as a potential $1-billion-a-year product -- was developed to treat irritable bowel syndrome which can cause disabling bouts of constipation, diarrhoea, abdominal pain and bloating.Copyright ï¿½ 2001 Yahoo! Inc. All rights reserved. Copyright ï¿½ 2001 Reuters Limited. All rights reserved.


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## Debbie Benning (Jan 25, 2001)

What does this mean? Should we be hounding the FDA again? This came out of the blue just when it seemed that it was lost cause. I hate to get my hopes up yet once again only to be sorely disappointed again. What should our next step be? I am going crazy with this hole thing. It has been over a year now and nothing even comes close to the relief Lotro provided. Not even Zofran. Jeff, what should we do?


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## LotronexLover (Jan 10, 2001)

A week ago. janet (FDA) told me that we would hear "something" in the next few months. I am guessing that maybe things are going well for us. (for once). I am reading positive things into this. I wrote to Janet again today.


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## LotronexLover (Jan 10, 2001)

Ok, Janet (FDA) just wrote to me. This is the low-down. "Glaxo has just made the first step this is what he is refering to. There will be other steps. Hopefully these steps will be made public."Can someone please pass this along to the Lotronex Action Group. I would but I am swamped with work. If someone can call Glaxo that would be great too.


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## Jeffrey Roberts (Apr 15, 1987)

Will do.Thanks!Jeff


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## DigestDan (Nov 30, 2000)

I am (cautiously) heartened by this news. I just E-mailed Janet W. (again) to give some support. I urge others of you to do so. Maybe we are close....after so long....Dan


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## Lisa K (Jan 2, 1999)

Thanks Jeff, and Everyone here....aaahhh for the Love of Lotronex! Music in the making!!! no more rumbly tummies?! Yes I will also write Janet tonight, she has been the most expressive and as supportive throughout this entire Lotro -tug-o-war.... I am also delighted (on tippy toes!) to hear of prospective lotro comeback at whatever market distribution. Once we hear of the further GSK steps, we can plant our feet firmly on the ground and smile, one long over due sigh of Gastro RELIEF. WE DESERVE something positive finally!Take Care everyone.will post her response as I receive it.Thanks again for making me SMILE today folks





















Lisa K


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## DigestDan (Nov 30, 2000)

Response from Janet W. (I think I like her more than George W.):"Thank you for writing. We are working hard on this and hopefully will beable to update the public on this matter. Your experiences echo many othersI have heard from. I recognize that there are not good treatmentsavailable, and that people have to try drugs that have been studied andapproved for other conditions."Sounds a bit positive. Let's keep writing her with our Christmas wishes...My wish is for something small, blue, goes good with food, and certainly fits in a stocking....Dan


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## VernaEileenR (Feb 23, 2001)

For fear of upsetting the applecart I'm trying to be "quietly" (for me) optimistic.







verna eileen radcliffe in michigan, usa http://petitiononline.com/LOTRONEX/petition.html


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## Kitty Kat (Jun 26, 2001)

Hi AllHave been lurking, not posting, since Lotronex seemed to be doomed. Taking Zofran 2-4mg/daily with good results, but was better with the old stand-by Lotronex. Can I really hope with REAL hope? Like all the rest of us, I am breathing a bit easier with some hesitation, but want so badly to believe the impossible only a few weeks ago is now possible. Thank you for your hard work and keeping us updated on any little sliver of hope. Pray its true!!!!!!! Kitty Kat


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## MALI (Jul 8, 2001)

All i want for Christmas is Lotronex!!! MALI


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## Debbie Benning (Jan 25, 2001)

Here, Here! Mali. I will consider myself the luckiest person in the world if this were my gift.


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## Blueroses (Dec 23, 2001)

Reading that news release, I have to say my heart really goes out to Glaxo, et. al., since Lotronex won't be a big "money spinner" for them, and that it won't be a big deal to them whether the drug comes back on the market or not. Hmmm. As one of the millions who may be compelled to use the drug if it does come back, I will regret every penny that goes to that company and its shareholders. A shameful display of greed and insensitivity. Shame on them.


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## LotronexLover (Jan 10, 2001)

Personsally, I think we should give ol' Glaxo a call. They keep track of the call volume & I think they need to know that many people are still interested in taking Lotronex. I called on Friday & it seems that they haven't been receiving many calls lately regarding Lotronex.


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## Blueroses (Dec 23, 2001)

Hi all,I think a message I posted was deleted, or I'm looking in the wrong place (paranoia), but I wrote my gut reaction--pun intended-- to that Glaxo news release. Is anyone else angry that Glaxo puts out such an insensitive and obviously money-hungry statement? (Lotronex is not a "Huge money spinner" and whether or not Lotronex goes back on the market is not a "major event" for the company). This is from the Chief Executive of the company! As one of the millions who may be compelled to take the drug if it comes on the market again, I will regret every penny that goes to Glaxo and its shareholders. I will try to be positive and hopeful with the rest of you, but I will remain angry that such a statement was released.


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## Debbie Benning (Jan 25, 2001)

I agree. I am angry and I thought the statement was low life.


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## Lubner (Feb 20, 2001)

I did e-mail Janet Wood**** asking if this was generating false hope. Her reply, " No, this is not false hope, forward steps are beingtaken." I remain hopeful for the New Year.


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## maumie (Jul 29, 2001)

Very well said, blueroses. I agree with you 100 percent. Could that company sound any more callous and hard-hearted? Shame on them.


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## Lubner (Feb 20, 2001)

Got another stupid form letter from Glaxo suggesting that I contact my doctor for alternative treatments to Lotronex. What a joke! It makes me so mad that I wrote them a not so nice note back:Your form letter is not very encouraging that your company has the capacity to empathize with the concerns of those of us with IBS that have indeed benefited from Lotronex. Your suggestion to contact my health professional for other treatment is absurd. Of course we can ask for other treatment, but as you well know there is no other treatment like Lotronex. Until Glaxo is willing to put Lotronex back on the market or another company develops a new version, most of us are s### out of luck! Thanks for nothing. I'm trying to be optimistic here, but the level of indifference on their part is sooooo irritating!


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## AliceAllen (Mar 20, 2002)

When Lotronex was taken from the market, I called GlaxoSmithKline and talked to them They said that the people who died could likely be a coincidence that they were taking Lotronex when they died and not the cause of death. I then called the FDA and he told me that they did NOT take Lotronex from the market, that gGaxoSmithKline had done so. He also said that if it were to come back it would have to be prescribed for IBS-D from a doctor that deals with gastrointerologist disorders. So here I am waiting for its return.


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## reeree (May 7, 2001)

Alice Allen, I too am waiting for Lotronex to return. I felt like I died and went to heaven when I started taking Lotronex. My confidence in myself returned and I got around so much more. I've had IBS with D since I was 18 years old. I'm now pushing 53. I'm used to everyone telling me it's all in my head. Is there any campaign to get to Glaxo to try and influence them since that meeting is coming up April 23rd......ReeRee


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## Oksana (Dec 11, 2000)

Glaxo is not "heartless" they are just a big corporation out to protect themselves from our (America's) litigious society.What killed this drug for Glaxo...Why they have NOT fought the FDA is all the lawsuit-happy attorneys who jumped on the SUE GLAXO BANDWAGON when Lotronex was withdrawn by the FDA! If you did a web search at that time on LOTRONEX, what it lead you to was a website owned by a large law firm in SF that was beating the bushes to get more "victims" to sign up to sue the hell out of Glaxofor causing them harm by producing Lotronex.I took it for 7 months and it was a GODSEND. It also gave me the proof that my IBS w/ D of 26 years is NOT due to my "nerves", "stress" or being a woman. I can now tell people it's because I produce too much Seratonin-5. Lotronex cured me within a few weeks... And it stopped all those "helpful" friends who assume it's due to a mental problem rather than a real physiological one.So, just to clarify, WE are suffering because malpractice attorneys are making millions suing Glaxo and other drug makers, for developing new drugs, some of which cause side effects. Until people in the US take responsibility for their own health and stop blaming others for their problems, we will continue to have effective medicines taken off the market due to FEAR OF LITIGATION. IMO, smokers who get lung cancer and sue are a classic example. No one forces anyone to smoke and anyone that doesn't know that smoking causes lung cancer must be from another galaxy!And, just to add more fuel to the fire.. There are numerous vaccines and medicines that are not sold in the US but that are sold in Europe, Australia, etc, and they are NOT sold here because the pharmaceutical companies fear lawsuits. There's a Japanese Encephalitis vaccine that is not available in the US and it's been widely available for almost a decade elsewhere. The drug maker refuses to sell it here for fear of lawsuits due to reactions. This is also why the lyme disease vaccine is being taken off the market. So, please don't beat up on Glaxo for covering their butt... because that is what they are REALLY saying. They were making millions on Lotronex, but the lawsuits due to the 3-6 deaths will cost just as much... So they are loathe to reintroduce Lotronex because they are afraid of someone else dying (who should not have been on the drug in the first place) and their family suing for wrongful death. It's all about profit and they develop new drugs to make profits... but if the new drugs cause lawsuits then that cuts into profits. I DO think pharaceutical companies need to put out safe drugs, but I don't think people should have the right to sue for hundreds of millions of dollars when they CHOSE to take Lotronex or they chose to smoke cigarettes for 20 years. The reason they want to make a profit is so they can spend millions researching and developing NEW drugs. It's capitalism at it's finest, whether you like it or not, that's the real reason they're not chomping at the bit to bring Lotronex back.


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