# Glaxo Withdraws Lotronex Bowel Drug in U.S. Over Safety Concern



## Jeffrey Roberts

11/28 13:26Glaxo Withdraws Lotronex Bowel Drug in U.S. Over Safety Concern By Kim Dixon and Kristin ReedWashington, Nov. 28 (Bloomberg) -- Glaxo Wellcome Plc said it would withdraw Lotronex, a drug to treat a bowel disorder, from the U.S. market after it was linked to serious gastrointestinal side effects.Glaxo said it withdrew the drug at the request of the U.S. Food and Drug Administration. The company and the agency had been in discussions over whether the bowel treatment could be marketed safely orshould be pulled from pharmacy shelves.Even though the company strengthened warnings on the drug's label in August, reports of abdominal problems persisted, prompting Public Citizen, an advocacy group founded by Ralph Nader, to petition for the drug's withdrawal.Lotronex was the first drug designed to treat irritable bowel syndrome, which causes abdominal pain and diarrhea, constipation or a combination of the two. Lotronex treats the form of the disease that causes diarrhea.Since its approval in February, the drug has been linked to ischemic colitis, a condition characterized by abdominal pain and rectal bleeding, and to constipation, sometimes so severe that hospitalization has been required.[This message has been edited by Jeffrey Roberts (edited 11-28-2000).]


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## Jeffrey Roberts

Tuesday November 28 4:22 PM ET Glaxo Pulls Controversial Drug Lotronex By Ben Hirschler, European pharmaceuticals correspondent LONDON (Reuters) - Drugs group Glaxo Wellcome Plc (GLXO.L) on Tuesday withdrew its controversial treatment for irritable bowel syndrome, Lotronex, from the United States and abandoned plans to sell it in other markets. The withdrawal was made at the request of the U.S. Food and Drug Administration (news - web sites) (FDA), which had voiced deep concerns about the product's side effects. An FDA official said on Tuesday three deaths were ``possibly'' related to Lotronex. The company said it did not agree with the FDA's interpretation of data from patients treated with Lotronex, but said it was complying with the request nonetheless. ``We greatly regret this outcome and believe that Lotronex is effective, that its side effects are manageable, and that the benefits of the product when treating IBS (irritable bowel syndrome) outweigh the risks,'' said James Palmer, Glaxo Wellcome director of medical, regulatory and product strategy. Glaxo -- which is in the process of merging with SmithKline Beecham Plc (SB.L) -- said it discussed a range of initiatives to educate physicians about managing potential side effects, including label changes, but the FDA had found them inadequate. Lotronex has been linked to reports of a bowel condition called ischemic colitis, which restricts blood flow to the colon, prompting the U.S. consumer group Public Citizen to call for it to be withdrawn. Some Lotronex users also reported severe complications from constipation. Three Lotronex users died after having ischemic colitis or severe constipation, leading FDA officials to conclude their deaths were ``possibly'' related to the drug, Dr. Victor Raczkowski, deputy director of the FDA division that reviewed Lotronex, said in an interview. Also, 49 patients taking Lotronex had ischemic colitis, and 21 had severe complications from constipation, Raczkowski said. Knowing that irritable bowel is difficult to treat, the FDA suggested keeping Lotronex on the market with restrictions to try and make sure the drug was used safely, Raczkowski said. ``We were trying to come up with other options'' besides removing the drug, Raczkowski said. But Glaxo's offer to provide additional education and update the drug's label was ''insufficient,'' he said. A Commercial Flop A total of 500,000 prescriptions have been written for Lotronex since the product became available for treating women with diarrhea-predominant irritable bowel syndrome in March. That was well below expectations, making Lotronex -- initially touted as a ``blockbuster'' drug -- a commercial flop. Analysts had forecast peak sales for Lotronex of up to one billion pounds ($1.42 billion) but the number has since come down to around 300 million pounds. Sales from mid-March to the end of June this year totaled 19 million pounds and analysts expect year sales of around 50 million. Nigel Barnes of Merrill Lynch said the loss of Lotronex was a blow to sentiment but would not significantly affect the fundamentals of the merged GlaxoSmithKline, which will be the world's largest pharmaceuticals group by market share. ``It's important to keep this in perspective. In 2004 we are looking for a combined revenue base for the new GlaxoSmithKline of 25.9 billion pounds -- and this is a product we were expecting to have revenues of 267 million in the year, or just marginally over one percent of the total,'' he said. Another analyst said Glaxo's literature for doctors did not adequately explain the risks of the drug. ``It wasn't the best job in launching the drug. They should have done a better job in the literature (drug label) so doctors could understand the proper use of the drug,'' said Henry Thompson, senior vice president of Fiduciary Trust Co. International in New York, which manages $50 billion in investments. Lotronex is also approved but not yet marketed in Mexico, Argentina, Brazil and South Korea and Glaxo has over 30 regulatory submissions pending around the world. The company said it now planned to relinquish licenses where granted and would withdraw all regulatory submissions. Lotronex is the first of several drugs being developed for IBS. Switzerland's Novartis AG (NOVZn.S) said earlier on Tuesday it had collated new trial data showing its rival product, Zelmac, provided rapid and effective relief. Novartis will present its findings to the FDA next month and hopes to launch Zelmac in the U.S. by mid-2001. It has signed a co-promotion deal with Bristol-Myers Squibb (NYSE:BMY - news). ($1-.7036 Pound) (With contributions from Lisa Richwine in New York)


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## Jeffrey Roberts

Glaxo Wellcome to withdraw Lotronex from the U.S. marketDecision follows in-depth discussions with FDARESEARCH TRIANGLE PARK, N.C. (November 28, 2000) - At the request of theU.S. Food and Drug Administration, Glaxo Wellcome Inc. announced today thatit will voluntarily withdraw its prescription medicine, Lotronex* (alosetronHCl) for the treatment of women with diarrhea predominant irritable bowelsyndrome. While the company disagrees with the FDA's assessment of thesafety profile of the product, Glaxo Wellcome will cease distribution ofLotronex immediately.Glaxo Wellcome took this step after in-depth discussions with the U.S. Foodand Drug Administration about gastrointestinal side effects that occurred inassociation with the use of Lotronex. There have also been rare reports offatalities from complications of gastrointestinal events although a causalrelationship to Lotronex has not been established. Glaxo Wellcome hasproposed a range of elements that the company believed would adequately andeffectively address these risks. These have included further labelmodifications, restricted distribution, on-going patient education, newclinical and epidemiological research and use of an independent medicalreview board. The FDA, however, disagrees as to the adequacy of theseproposals and has requested that Glaxo Wellcome voluntarily withdrawLotronex from the market. "We greatly regret this outcome and believe that Lotronex is effective, thatits side effects are manageable, and that the benefits of the product whentreating IBS outweigh the risks," said James Palmer, M.D., Glaxo Wellcomeplc Senior Vice President and Director, Group Medical Regulatory and ProductStrategy. "Thousands of women are benefiting from Lotronex, and withoutthis medicine, many of these women will have to resort to therapies that didnot adequately treat their symptoms in the past."Palmer said that Glaxo Wellcome takes a different view from FDA on theability to educate physicians and patients about the management of potentialside effects and benefits of Lotronex. Irritable bowel syndrome is a chronic, recurring condition that affects anestimated 1 in 5 Americans. Although the cause is unknown, IBS ischaracterized by multiple symptoms that include chronic or recurrentabdominal pain and discomfort and irregular bowel function. Lotronex received FDA approval for the treatment of women withdiarrhea-predominant IBS in the U.S. on Feb. 9, 2000. It is the firstmedicine in many years proven in well-controlled large clinical trials toaddress multiple symptoms of the condition. More then 450,000 prescriptionshave been written since the drug became available in March 2000. In line with the company's practice, Glaxo Wellcome has closely monitoredthe safety profile of Lotronex since its introduction. In cooperation withthe FDA, Glaxo Wellcome has provided updated and extensive information onappropriate use to both health care providers and patients. Glaxo Wellcome representatives will immediately contact health careprofessionals to advise them of the discontinuation of distribution andmarketing. Physicians will then begin contacting their patients to discuss aplan to transition them to alternative therapies.For more information, health care providers and patients may call 1-888-TALK2 GW (1-888-825-5249)# # #


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## Guest

Jeff,Words cannot describe my anger and sadness at the news of Lotronex being withdrawn from the market. The FDA and Sidney Wolf are out of control! They obviously don't suffer from IBS. This drug has changed my life - guess I'm back to Bentyl and Immodium. YUCK! I have been so ashamed to admit that I have IBS and now it has taken an event such as this to bring me to a support room. God help us all,tommom


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## LUCIA

Will Lotronex still be available in Canada, Mexico or any other country? Will somebody please check and let me know?------------------


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## Guest

Hi:I've been reading the BB for a long time, but have not posted. I feel I have to now because I don't know what we are going to do without Lotronex. We have to do something. I have been on Lotronex since March and it is the only thing that has given me some relief. Please! Is there any where we can write or call to have the FDA change their minds. Maybe if they know how many people have been helped and haven't had any problems they might reconsider. If anyone has any suggestions, please let us know.


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## Anxious

Wow! Isn't this a shocker?! I'm sorry to all who have been helped by this drug. What a disappointment this must be. I was afraid to try Lotronex for this very reason - side effects.


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## Guest

Remeron (Mirtazapine) remains a viable alternative. Remeron works in part by the same mechanism as does Lotronex (blockade of the 5-HT3 receptor.) Unlike Lotronex, Remeron has *not* been associated with ischemic colitis, and is effective for both men and women.


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## JJKWright

I listened to Dan Rather in disbelief tonight when I heard him announce that Lotronex was being withdrawn. I was hoping this was another of Dan Rather's "premature announcements." As I raced to my pharmacy, I choked back tears as I remembered what life was like before Lotronex. Now the uncertainty of whether I will be able to hold my job, go to the mall, eat out, even talk on the phone, is becoming a reality once again. Sure there are people out there who shouldn't take Lotronex. That's true with every drug. But, for the 300,000 of us that are on it, it has been worth the risks, which I believe are ever so slim. The Ralph Naders of the world should get a life, or just one attack of IBS would probably do the trick. So, where do we go from here?


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## jenEbean

The drug rep came to our office shortly after 12:00 noon today to let us know that Lotronex has been stopped. Talk about ironic, there I stood literally flushing samples of it down the toilet. Broke my heart. I am going to hang on to my couple of pills left to take on vacation with me in January.


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## Guest

What a nightmare! Lotronex was the best help I have had in 29 years of IBS. I hate the idea of going back to the way my life was before Lotronex.


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## Kimmie

How can they do this to us??? My life will be in the toilet! No PUN intended! People have died from using tampons and they are still being sold! People die in cars...but we still drive them! I am in shock!...tears! I can't go back to how I was!! I just can't! Isn't there something we can do?


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## Miss Patience

Me again. Still upset. I called in a refill of my Lotronex as soon as I heard the news, and was able to pick it up from the pharmacy. If I take one pill per day instead of two, I can go two months. I hope one pill works.But then what? I went to a party this weekend and ATE for the first time in YEARS. I had thanksgiving with my Beloved's family and was able to eat dinner. NOW WHAT? My old life of anxiety attacks and isolation? Of never/rarely eating in public? Of what should be wonderful times ruined by an attack? I'm scared of what this is going to do to my relationship with my boyfriend. He says not to worry. But don't worry, IBS isn't life threatening.I think what is so upsetting is the feeling that this was done TO us, the folks for whom this drug WORKS, with no problems. No one asked US if we've had problems, or what the benefits have been.I guess I'll tell the Beloved to buy me a case of Immodium for Christmas.Colleen


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## Guest

The do-gooders have helped us out again. Saint Ralph Nader saving us from ourselves.I guess it's back to Imodium and Lomotil.I have friends who live in Mexico for the winter, maybe they can get it for me.


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## Guest

This is not the first or last time the FDA has done this. Remember...they know what is best for you....not you, not your doctor.Makes you sort of appreciate the Libertarian philosophy.


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## vikee

I was shocked also. You can read more about this at: http://www.safetyalerts.com/recall/f/004/lotrnx.htm ------------------vikee


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## DGGinNYC

It saddens me so much to see so many of my friends in distress. I know there are trials of other drugs going on. Maybe this move will press those companies to get the lead out.Those of you who found relief in Lotronex, you are in my thoughts. There is more help on the horizon. Try to stay strong.-------------------Dan


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## JeanG

This is so sad. I know Lotronex has helped so many of you, and I hope and pray something else can be done. JeanG


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## Guest

this is horrible. what are we going to do? i was almost forgetting that i had ibs. thank you to the government for helping us all!!!


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## John

My sincerest sympathies for those who have had great success with this medication. I hope and pray for those individuals that something else will come to their rescue. Luckily for me, Effexor XR 75 mg/daily (an antidep) has been a godsend for me. Guy has also mentioned Remeron (antidep) in the past for those with D. To those individuals who are unfortunate enough to be taking the Lotronex and are now finding out the bad news. My prayers are with you. *SincerelyJohn*


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## echris

I'm one of the many who did benefit from Lotronex, so I'm not very thrilled by big brother. I've searched all of my data bases and still can't find much on Remeron. On PDR (Electronic) it doesn't even mention GI indications for it, although constipation is a reported side effect for 13% of the patients who have taken it in studies. Hope that my GI doc has some good ideas. I'll see if I can get a refill in the morning.


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## JuliaNYC

I can't even begin to express how upset and depressed I am by this news. As one of the thousands who was given back her life thanks to Lotronex, I can hardly believe that Dr. Wolfe and the FDA have taken that away from me! Remeron may not cause ischemic colitis, but since its PDR indications are for depression (which I don't normally have), I have my doubts that my insurance will pay for it for IBS. I have enough Lotronex to last for a month; after that I don't know what I'll do! I can't go back to the virtually homebound life I had before. I will be discussing this with my gastro in the a.m. She and I have been discussing the possibility, and I wrote letters to both the FDA and Dr. Wolfe while the controversy was going on; needless to say I didn't even get replies to the letters. Obviously no one involved in this decision has ever had IBS.


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## Guest

I just got a phone call from my father telling me the sad news about Lotronex. I too have experienced a most amazing and positive change in my life because of the success of this drug. Now I will join others like tommom. It's back to Bently and Immodium (and getting up a half hour to 45 minutes earlier for work). This sucks more than words can express. I did read that there is a new drug "Zelmac" on the way (unless they find that too risky too).


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## Guest

I guess I should have done my homework before posting. Zelmac is for those with constipation. Sorry. I too am going to try half doses. I tried it before and wasn't too successful but I don't know what else to do.


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## Guest

Basically, the FDA, still smarting from the Phen/Fen fiasco, is protecting the handful of doctors who wrongly prescribed Lotronex. Another drug, Cilansetron, which works similarly to Lotronex, is currently in testing.


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## eric

Here is some more info.. http://biz.yahoo.com/rf/001128/l2827826.html http://biz.yahoo.com/rf/001128/l2814772_2.html http://biz.yahoo.com/rf/001128/l2814772_4.html ------------------ http://www.ibshealth.com/ www.ibsaudioprogram.com


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## Homebound

When I saw this on the news I automatically thought of all of you. My heart just broke for all of you that has been helped so greatly by this drug. If it's so risky why don't they find these things out before they put it on the market? What do they do when their TESTING these drugs?? Not much obviously. I just wanted to express my deepest sympathy for all of you, and I can only pray these idiots get us something that they consider safe and that WORKS. Not too many of the remedies they offer work, and the one that does they pull. Ugh, just makes me so sick. (((HUGS))) to all of you!Jennifer


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## Clancy Garner

I just can't believe this.... talk about depressed!!! Maybe my drug store hasn't heard yet and I can get one last refill.I guess I'll try to get into the study on the new prescription and hope I do not get the placebo!!!!


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## IBS2

To Jeff, Is there any way you could forward responses posted on this board to the FDA, or give us a contact person email to send our objections?Tom


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## Kimmie

This was the only place that I found where I could leave a comment on how I feel. Here's the address if anyone wants to check it out. http://www.fda.gov/cder/comment/commentdrug.htm


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## NancyCat

This is just awful news for the many people who have really benefited from Lotronex. I heard it on my local news and on CNN this am. All you can do is try and refill your prescriptions (call your DR's and have them call in as much as they can legally)BEFORE the FDA OFFICIALLY puts out a notice to pharmacys. Theres a chance that it wont happen for a few days/I'm not sure what the legal time constraints are. Many years ago my Mom was on a birth control pill that was taken off the market rather abruptly because the FDA said it caused cancer in dogs. She called her DR who gave her all the samples he had as well as gave her several prescriptions for multiple pharmacies so she was able to get about a years worth of the medication. If your DR's dont object perhaps people who are getting relief from Lotronex could do something like that. This news totally sucks







------------------Nancy


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## catherine

I heard this sad news this morning on the radio and like others, instantly thought of all of the people here. I'm so sorry you all are going through this and it's the first time I've been moved to tears on this board. My prayers are with you all.------------------C-Type IBS (slow motility)


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## Rose

To those of you who have been helped by Lotronex, if I were you, I would NOT take this lying down. I would start making some BIG NOISE....to the FDA, to Glaxo and to the media, if necessary. MY heart goes out to all of you.------------------"Remember To Stop and Smell the Roses"Rose (C-type)


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## echris

bump


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## Guest

What now?Someone please tell me where do we go from here?I beg you not to say life before Lotronex,I didn't have a very good quality of life before this miracle drug.Also,why couldn't I log on,I had to re-register!------------------gypsy-D


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## Kimmie

The more I think about it the angrier I get! The FDA doesn't give a hoot about so many other things...such as dibutyl phthalate, or DBP that is found in beauty products that can cause birth defects to unborn children and other problems. Why do they have to pick on Lotronex??? Why do they turn a blind eye on other things and pick on this! I just can't bear the thought of going back to life before Lotronex! I feel so helpless!


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## Benjamin

This is such upsetting news. The last few months I actually felt like I had my life back. Went to dinner on my birthday for the first time in many years and enjoyed myself.It is sad for all of you who have been helped by lotronex as I have. Waiting to talk with my Dr. This news had made me so sad.Thoughts to everyone. Mary Jo


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## Bud

This pisses me off so much. This drug was the only med that has been effective for my wife. After living for 9 months in agony and fear of crippling cramps, and I do mean CRIPPLING, and explosive uncontrollable "D", this drug eliminated 95% of the "D" and 60%, at the least, of the suffering. For nine months, she couldn't come close to functioning as a normal human being. Since starting lotronex (July 17) she's gotten the biggest part of a normal life back and she's even attempting to go back to her part time work.Because of other's ignorance and stupidity, now she will be the one that is punished along with all the others that this med has helped. It's pure BS!


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## Clancy Garner

Well... since we lost Lotronex I have decided to participate in the new study on Cilansetron!!The current study is to try and find optimal dosage. There will be a 16 mg dose, a 2 mg dose and a placebo..... so I guess you have a 2 in 3 chance of getting the right stuff. I have been accepted into and just have to do the paper work.... let's hope it is as effective as Lotronex was!!


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## georgeb

Write to "Public Citizen" herehrg1###citizen.orgHere's what I wrote:Well, I see in the headlines today that Glaxco is pulling Lotronex. I'd just like to say thank you. Thank you very much for deciding for me that the only drug that have ever given me hope, allowed me to go outside without being afraid, and has effectively treated the cause of unspeakable amounts of pain in my life, is too dangerous for me. Thanks for being Big Brother.I'm sure that if any of you had this disease, you would not have pushed as hard as you did. You suck, and have brought pain and absolute agony back to my life,Sincerly,George BIBS-D Sufferer with no apparent hope for relief anytime in the near future.


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## Jeffrey Roberts

http://www.glaxowellcome.co.uk/cgi-bin/fra...ase/mn_PR975485 699.html[/URL] 28 November 2000Glaxo Wellcome withdraws Lotronex from the US market Glaxo Wellcome plc announces that, at the request of the US Food and Drug Administration (FDA), it will voluntarily withdraw Lotronex, its treatment for irritable bowel syndrome (IBS), from the US market with immediate effect. This step has been taken after in-depth discussions with the FDA about the interpretation of data relating to gastrointestinal side effects which have occurred amongst patients treated with the product. These have included rare reports of fatalities, although no causal relationship with Lotronex has been established. During its discussions with the FDA, Glaxo Wellcome has proposed a range of initiatives to educate physicians and patients about the management of the potential side effects and benefits of Lotronex, including further label modifications and patient education programmes. The FDA has indicated that it does not believe these proposals to be adequate, and has requested the voluntary withdrawal of Lotronex from the US market. Although the company disagrees with the FDAï¿½s assessment of the safety profile of the product, Glaxo Wellcome will comply with that request immediately. ï¿½We greatly regret this outcome and believe that Lotronex is effective, that its side effects are manageable, and that the benefits of the product when treating IBS outweigh the risks,ï¿½ said Dr James Palmer, Senior Vice President and Director Group Medical, Regulatory and Product Strategy, Glaxo Wellcome plc. ï¿½Thousands of women who have benefited from Lotronex will have to resort to therapies which did not adequately treat their symptoms in the past.ï¿½ Lotronex received FDA approval for marketing in the US on 9th February 2000 for the treatment of women with diarrhoea-predominant IBS. It is the first medicine proven in well-controlled large clinical trials to address the multiple symptoms of the condition. Approximately 500,000 prescriptions have been written since the drug became available in March 2000. Lotronex is also approved but not yet marketed in Mexico, Argentina, Brazil and South Korea and there are over 30 regulatory submissions pending around the world. Discussions are being initiated with regulatory authorities with a view to relinquishing licenses where granted and withdrawing all regulatory submissions. Glaxo Wellcome is a research-based company whose people are committed to fighting disease by bringing innovative medicines and services to patients throughout the world and to healthcare providers who serve them. Lotronex is a trademark of the Glaxo Wellcome Group of companies.[This message has been edited by Jeffrey Roberts (edited 11-29-2000).]


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## Guest

This is what I wrote to the FDA http://www.fda.gov/cder/comment/commentdrug.htm As an IBS sufferer of over 12 years, I feel the need to express how disappointed I am in your efforts to protect me from myself by forcing Lotronex to be pulled from the market. As a commercial pilot, IBS symptoms are not very compatable with my life. Additionally, the accompanying anxiety and (often) sense of panic impacts not only my professional, but private and public activities.Lotronex gave me, for the first time in my adult life, the ability to work and live worry free. Being able to eat in public, plan a long drive in a car, or enjoy a meal in someone's home may seem trivial to you, but to me was a new pleasure I've not been able to enjoy before Lotronex.Now, through your efforts, I'm forced to go back to my old lifestyle while searching for alternative treatments.Thank you again for your work...I'm sure you're very proud.Sincerely,Chris Rucci32 yo male IBS sufferer


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## Jeffrey Roberts

Glaxo Wellcome Canada writes:


> quote:I regret to inform you that further to the FDA request for voluntarywithdrawal of Lotronex (alosetron hydrochloride) in the U.S., Glaxo Wellcomeis initiating discussions with regulatory authorities to relinquishlinsenses where granted and to withdraw submissions worldwide. We willtherefore initiate discussions with Health Canada to end the review of ourLotronex submission.It is the view of Glaxo Wellcome and of expert counsel from a number ofGastroenterologists that Lotronex has an acceptable risk/benefit ratio.Since Lotronex was launched in the US in March of this year, it has givensignificant benefit to thousands of women. The FDA's request leaves thesewomen with few options but to resort to therapies that are largelyineffective or unproven.


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## Guest

This news is the worst! My husband who has suffered from IBS induced D for over 20 years has called Lotronex the Miracle Drug. It has changed his life and that of our whole family. So often he would have to stay home or cut outings short. He would have trouble getting to meetings and flights for business trips. I saw the article in this morning's USA Today. My husband happens to be away on business. I immediately ran to the pharmacy to get "one last refill". The pharmacist went to fill it and it was when he submitted to the insurance company he got the news. He came over to me and said he hadn't gotten a notice so i said well since you technically weren't informed, can you give it to me anyway? He asked me to sign a waiver of liability and then asked him that since we were going "off the record" could he give me a "double refill". He only had 40 pills in stock but he sold them to me! Of course no insurance so it was over $100 but well worth it. I feel so bad for those at the mercy of the insurers. Ino sooner got home and had a call from my husband who had just read the same article and was happy to report I had obtained a supply for him.One thought he and I had on the whole Lotoronex thing- is that maybe some people are taking too high of a dosage. What my husband found is that the pills have an almost immediate effect within minutes. It also seems to have a lasting effect. He used to have a "problem" at least 3 or 4 mornings a week now he can pinpoint triggers (usually having to be somewhere at a specific time and early in the AM)or travelling. He will take one pill on an as needed basis. He only takes a few pills a month. We happened to go away for a week and he took the pills as prescribed for several days in a row and got severe painful constipation, something he never had in his life. He went back to selective usage and is literally "cured" of IBS with no ill side effects. Granted his IBS is probably no where as sever as some of you but maybe this is a dosage thing and then again, maybe people should be able to decide for themselves whether the risk is worth it or not. After all they still sell cigarettes!I think we need to protest VERY loudly to FDA and Glaxo.


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## WellWisher

I, too, am dismayed and upset that Lotronex is being pulled off the market. I heard it on the news when I woke up this morning and have been shedding tears every since.I still have 90 pills on hand and since I only use them on a "need" basis I figure I'll be okay for many months. But then what? Imodium may be an answer, but it's only a limited choice.Does anyone know if Solvay (I think?) is still developing that Lotronex-clone drug. Maybe that will provide some hope.My prayers are with each and every one on this board who found relief and a new lifestyle when they benefited from Lotronex. At least we still have this board to comiserate on!


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## Jeffrey Roberts

Glaxo Wellcome's formal press release http://www.glaxowellcome.co.uk/cgi-bin/fra...R975485699.html 28 November 2000Glaxo Wellcome withdraws Lotronex from the US market Glaxo Wellcome plc announces that, at the request of the US Food and Drug Administration (FDA), it will voluntarily withdraw Lotronex, its treatment for irritable bowel syndrome (IBS), from the US market with immediate effect. This step has been taken after in-depth discussions with the FDA about the interpretation of data relating to gastrointestinal side effects which have occurred amongst patients treated with the product. These have included rare reports of fatalities, although no causal relationship with Lotronex has been established. During its discussions with the FDA, Glaxo Wellcome has proposed a range of initiatives to educate physicians and patients about the management of the potential side effects and benefits of Lotronex, including further label modifications and patient education programmes. The FDA has indicated that it does not believe these proposals to be adequate, and has requested the voluntary withdrawal of Lotronex from the US market. Although the company disagrees with the FDAï¿½s assessment of the safety profile of the product, Glaxo Wellcome will comply with that request immediately. ï¿½We greatly regret this outcome and believe that Lotronex is effective, that its side effects are manageable, and that the benefits of the product when treating IBS outweigh the risks,ï¿½ said Dr James Palmer, Senior Vice President and Director Group Medical, Regulatory and Product Strategy, Glaxo Wellcome plc. ï¿½Thousands of women who have benefited from Lotronex will have to resort to therapies which did not adequately treat their symptoms in the past.ï¿½ Lotronex received FDA approval for marketing in the US on 9th February 2000 for the treatment of women with diarrhoea-predominant IBS. It is the first medicine proven in well-controlled large clinical trials to address the multiple symptoms of the condition. Approximately 500,000 prescriptions have been written since the drug became available in March 2000. Lotronex is also approved but not yet marketed in Mexico, Argentina, Brazil and South Korea and there are over 30 regulatory submissions pending around the world. Discussions are being initiated with regulatory authorities with a view to relinquishing licenses where granted and withdrawing all regulatory submissions. Glaxo Wellcome is a research-based company whose people are committed to fighting disease by bringing innovative medicines and services to patients throughout the world and to healthcare providers who serve them. Lotronex is a trademark of the Glaxo Wellcome Group of companies.


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## Pat_H

Those of us who benefited from Lotronex with no problems must respond to Glaxo and the FDA. I tried all the recommendations on this BB, from Caltrate, diet modifications, corn starch glop ( I made it but couldn't bring myself to actually eat it) to Metamucil and Citrucel. None worked like Lotronex! This is a very sad day!


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## Guest

Lotronex is the first drug that has given me almost 100% relief from IBS. With its withdrawal I will be virtually house bound. I am most unhappy with this decision. Thanks for the various posts here.


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## Sherree

I have e-mailed the FDA, but I'm sure not much will come of it. I had just asked for a refill Monday, hadn't yet picked it up at the pharmacy. Now they won't let me have it. Bad timing on my part! I am down to 10 pills. Now it's back to Immodium and Caltrate, tho I have been taking the Caltrate anyway. Guess I will call the Dr. for Bentyl. If there is anything we can do, I will be happy to volunteer - whatever it takes! Now we all have to hope we can continue to manage our IBS, try not to get thrown into a depression, and hope for a new drug therapy, perhaps Zelmac...


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## Guest

Hi. I'm new here. I just wanted to add my 2 cents. I've had IBS most of my adult life. In recent years, it has become increasingly worse. When Lotronex came along, I felt like I'd been saved. I could go out again, I could go shopping, take long car rides and flying was no longer a nightmare. And more importantly, that horrible cramping and D was completely gone. I've only got about 2 weeks worth of pills left. After that, I don't know what I'm going to do. The talking heads and pundits who state, "IBS won't kill" should have to live with it. It won't kill, but you feel like it will.I called Glaxo this morning, and the rep I spoke with said the company was trying to work out some sort of solution. She said Glaxo has been inundated with calls pro-Lotronex, and they are going to work with the FDA to some end. She said possibly doing more studies, to a possible reformulation of the drug. I hope the rep wasn't just blowing smoke up my skirt, because I don't know what I'm going to do. I've tried so many other meds with no success. I guess its back to Immodium. May as well get some stock in that company.


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## mysteri

I did not even know til I was at the pharmacy and they told me I could not get a refill because it was withdrawn. I began crying in the pharmacy, sobbed through the store and all the way to the car and have not stopped yet. I have not cried like this since a family member died. I hope I can slow down before my immediate family gets home. They will think I am a nut. I have a call into my doctor but she has not called back yet. Maybe she has enough samples to get me through the holidays before I have to return to the Hell that will again be my life. Life if that what you call it - exisistance is more like it - a diarrhea making machine that sometime gets to go to work and sleep a full 8 hours. I took 2 pills a day everyday since June and did not have a C problem. God, I am so depressed . . .


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## Missycat

What bugs me about it is that it *can* be safely used, *in the right patient population!*. My understanding is that it should never be used in people that have any kind of constipation, as those people are much more at risk for serious side effects. Glaxo worked with the FDA to get this information sent to doctors and pharmacists, and they either refused to pay attention to it, or they didn't read it. I work in the pharmaceutical industry, and my *Number 1 Gripe* is that doctors do NOT read the package inserts!







The PIs contain vital information related to dosing, side effects, indications, etc., and physicians simply do not read them. This drug withdrawal, in my opinion, is simply because doctors are not prescribing the drug correctly and not monitoring their patients. The FDA had no choice but to recommend the withdrawal, because they've al already tried to educate the professionals and it failed.







There! I've got that out of my system. Grrrrrr........







------------------Fear can hold you prisoner.......hope can set you free.*Missycat* >^.^<


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## JJKWright

When I woke up this morning, I had that feeling of impending disaster that I couldn't pinpoint until I got my bearings together and remembered that yes, Lotronex was pulled off the market yesterday and, no, it wasn't a bad dream I was waking up from. My co-workers are already thinking that I am probably going to have to quit my job because of this. I just hope Glaxo comes to the rescue before that happens. We have a daughter in college and if I ever needed to work, it's now. We are all in so much danger with everyday risks like driving a car, breathing second hand smoke, chemicals and preservatives in food, pollution, weapons, etc. etc. that by comparison, the risks of Lotronex are miniscule. What's wrong with them anyway? We don't need them to decide for us. Wonder if the FDA will be willing to pay my bills, do my household errands, work my job, and pay my daughter's college tuition for me, now that all of that is seriously threatened? We've got to kick and scream loud about this. I've called Glaxo today and e-mailed them. I'm suggesting everyone do something to help us be heard.


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## Libbys

My sympathies to all Lotronex users! I started it this summer, then heard about the first "cases" and stopped.. then just got it again last week and now this! Let's hope one of the initiators of pulling the drug gets a bang-up case of IBS d; is forced to stay in his or her lab near the john to work MADLY on another drug!


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## Guest

My Doctor's office called me this morning to tell me the news and I join the rest of you in proclaiming this a very very sad day. I broke out into tears. I've been using Lotronex successfully since last March and it's depressing to think of going back to the way life was before Lotronex. Just last week I was at the Dr's office for a check-up and was telling him how GREAT everything was. Even he and the Physician's Assistant were feeling really bad that they had to call me with the news. At least I'm one of the lucky ones who has a Dr. and PA that know this is a real problem and will be willing to work with me on what to do next. As for the social ramifications of the lack of Lotronex, it brings tears to my eyes just to think about it. Hopefully there will be something else SOON!! A new drug would be a nice Christmas present....until then I except there will be immodium in my stocking!Best of Luck to you All!


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## Missycat

Hey everybody - let me suggest one thing here - *protest* to the FDA - they're the agency that asked Glaxo to pull Lotronex from the market. Send your *support* to Glaxo, who all along has said that this drug is safe when prescribed to the right patient population and used properly.From working in the pharmaceutical industry, I know it's not Glaxo's fault Lotronex was pulled. It's the FDA's inability or refusal to work with Glaxo. Glaxo wanted to keep it on the market and make sure it was given to the people who needed it most, but the FDA wouldn't go for it. Glaxo should hear your stories to understand how important Lotronex is and how much it has changed your lives. It might help them fight the FDA and show them that there are severe cases where Lotronex is needed, and safe to use. Maybe then the FDA might agree to it being reintroduced in a limited patient population.Oh - and during clinical trials, you're dealing with a vastly smaller subset of patients who are using the drug properly, compared to when the drug is on the market and possibly being used in inappropriate cases. It's a hard fact of life, but a pharmaceutical company cannot see all possibilities of adverse events with a product until it has been on the market, because the numbers of people using it are greater, and all sorts of other confounding factors are introduced in the general public that are not present in clinical trials. Clinical trials are controlled; postmarket use is not. Everything went according to plan here; except for the FDA not being willing to see that Glaxo could market this for limited cases, and closely monitor them to ensure safety.If you really want to protest, go protest to Raplh Nader's watchdog group; the FDA listened to them more than they listened to Glaxo.All the appropriate links to all of these groups are somewhere in this thread. Go to it!------------------Fear can hold you prisoner.......hope can set you free.*Missycat* >^.^<


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## Guest

Hello All,I feel like I am going to get eaten alive when I say this but, I am thinking about the women who have DIED. Thousands are using it successfully - does that mean we disregard the people who have died and required hospitilazation and surgery? I just want to say I am a Lontronex user. I feel for all of us - really I do - but I can't help but to wonder if these women died in vain. Don't their deaths mean anything? Perhaps it will come back on the market once all these deaths and problems are cleared up? Just a thought.


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## zigmissus

Amen, Missycat. You're right on the money about the problem being that doctors aren't reading product inserts and prescribing accordingly. My doc prescribed Lotronex to me, despite the fact that I told him I had constipation about 10% of the time, which always ends in explosive diarrhea. It was on this BB that I learned that this is probably a contradiction to taking Lotronex, so I never filled the prescription. (Wish I had, so I could send it to some of you guys!) I'm sure my dr. assumes I'm taking it, but unlike (lucky) BQ's physician, he hasn't contacted me. My heart goes out to all of you who are being deprived of an effective drug. As so often happens, people who use a product responsibly are penalized in the name of protecting the careless and the ignorant.


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## lilymaid

Hi all,I was really happy to hear that Lotronex had worked so well for people-- but I'm reading these posts because now Lotronex is unavailable!!!! I feel for all of you that have been on it and have had success.I wonder if the FDA is taking into consideration that perhaps the gastros that prescribed Lotronex did so without enough knowledge, or if the women ignored warning signs and continued to take it even though they shouldn't have.In any case, I've had a bout of D that's lasted for two months now. About two weeks ago, the gastro wanted to put me on Lotronex even though my history is clearly IBS C/D, emphasis on the "C" until recently. But I declined and decided to try Immodium. Although IBS makes me miserable, I am NOT experiencing D to the level that many of you have mentioned.Dear God. Are we ever going to come up with a good solution to this????? (sigh!)Regards (and best wishes to all), Lilymaid


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## Guest

I called in a refill yesterday as soon as I heard the news with not much hope. The pharmacist called today to tell me it was pulled, but that he would give it to me because I called in before he was informed.I had cut down to 1/2 3 times a week, but I may try twice a week or maybe cut them into 1/3. Anything to make them last as long as possible. I've been taking it since May with no side effects except the initial C before I regulated my dose. I will join the rest of you and make calls, send E-mails whatever might help.debbie


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## Loraine

I have been on Lotronex for only a month, I was just getting the dosage for my body regulated. Now this! I called my doc as soon as I heard it on the noon news, he said no just keep taking it, I was reading the paper this evening and it said what I thought it said, that it had been pulled from the market. I went to my pharmacy asap..they gave me a refund(which was nice of them) and I had to refill my old script of hyoscamine which worked when it felt like it...Now what? I was really looking forward to some relief with this new drug. And another thing, when they refer to IBS as a not life threatening problem, I beg to differ with them, sometimes I can't imagine another 9 years of this, I often wonder why me..or if i'm gonna die from this someday. They really need to take this more seriously and consider IBS as a disability not a disorder. I can't work, or go to functions at my kids school, shop with friends and go to lunch like normal people... I hate my life sometimes!!! thanks for listening...after i got the news of Lotronex being taken off the shelf I instantly got "D"..now what?[This message has been edited by Loraine (edited 11-29-2000).]


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## Guest

I want to say I'm very sad for those of you getting relief with Lotronex. I was just diagnosed with IBS and doc gave me 2 weeks worth to start on last week. I had to stop over the weekend because of constipation and worse pain - I actually ended up in the E.R. So this was not a medication for me, but if there was one that helped me, and I couldn't take it anymore, I would be so upset.


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## JuliaNYC

Well, I've called Glaxo and been told they've gotten thousands of pro-Lotronex calls. I've written to the FDA (but I did that before, during the controversy, and got no response). My e-mail to public citizen brought me a form reply directing me to their petitions (now successful) to get rid of Lotronex. I feel like no one outside of the BB wants to hear of success stories with the drug. My mail order pharmacy plan cancelled the prescription they had pending for me, so when the 80 pills I have left are gone, that's it! I can't imagine going back to the way my life was before Lotronex, so I will keep writing in protest to all possible sources. My doctor has been trying to contact Solway about their progress with Cilancitron, but the phones have been busy all day, not surprisingly. The last time she was in touch with them a few months back, they were estimating 2 years before Cilancitron is available outside of clinical trials. All in all it's been a very depressing day.I second the note from Tom above. Can we somehow get all of our postings to the FDA?


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## Guest

It's certainly a sad day.I agree we need to do everything we can to get this med back on the market. I can't imagine going back to the way it was.


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## Jennifer7

Let's get organized about this! Anyone haveany suggestions on what would be an effectiveway to go about it?


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## Kimmie

I got an email today that I would like to share:Hi. I am a reporter for The News & Observer in Raleigh, NC, and I amworking on a story about the withdrawal of Lotronex from the market. Iam interested in talking to people upset about this, and saw your poston a bulletin board. If you would be willing to talk to me and be quoted(by name), please call me today.....He gave me his number and I got the email too late to call today but I emailed him back and I will be calling him tomorrow. Did anyone else recieve an email like this???


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## Jeffrey Roberts

I received that email message Kimmie.I called and we spoke for about 10 minutes.Jeff


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## JJKWright

Yes, I got that e-mail too but too late to respond today. Glaxo has heard from me by phone and e-mail today. In response to what Brittany said about the women who have died -I was thinking about the millions who have died from smoking related illnesses yet the FDA allows that stuff to still be sold. What about toxic shock syndrome??? The cause of that is still being marketed. People have to take some responsibility for their own bodies and have sense enough to know if something is going wrong. I can't believe these few people just fell over dead from taking Lotronex without some warning signs.


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## Guest

I took Lotronex for a couple months and it worked great - but my insurance wouldn't pay for it. I am on Questran now with great success, but Lotronex was always my ace in the hole if it didn't work.I am devastated for all of you that are affected by this loss. I wrote a letter of protest using the link to the FDA that Kimmie posted. My heart breaks for you.


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## Persistance

Yes, this must be devastating to those of you for whom Lotronex was a godsend. I have not gotten around to trying it because other medical problems got in the way. But take heart, as DGG and Vikee and others have said -- there are other drugs being tested and hope on the horizon. For one thing, from my reading, I know that the 90's were the first decade that researchers began to take this condition seriously and there is work being done in many areas of the IBS puzzle involving serotonin and the mind/body connection. Cilansetron -- hopefully -- will finish its endless trials and be out one of these days soon. And there's more.


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## Guest

I am new to your bulletin board. I am a 25 year old female who has been suffering with irritable bowel syndrome since feb 1997. I was started on Lotronex after trying multiple of drugs. I found that Lotronex was the best thing to happen to me. Mind you I did become severely constipated twice but was able to care for it myself and since then I have been able to control it by just taking half a dose twice a day instead of a whole pill twice a day. I was devastated when I heard the news over the radio on my way to Christmas shopping (I usually spend most of the time in the bathroom before Lotronex). I wanted to cry. I saved all my tears until I came home and found out it was true. What am I going to do? I have a very stressful job and usually don't get a chance to take a break to go to the bathroom. I am a nurse and can't tell my patients and their families to excuse me as I got cramps. What am I going to do?


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## Jeffrey Roberts

I have received an unprecedented number of email messages about the withdraw of Lotronex. The activity on the BB yesterday was more than double an average day. This is obviously an important issue to many people.I am preparing a Press Release as to everyone's concern and hopefully it will get picked up by the press.Will keep you posted.Jeff[This message has been edited by Jeffrey Roberts (edited 11-30-2000).]


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## echris

bump to top


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## jenjen

this is all so sad. i am trying to remain hopeful. i am thankful that there is a place like this to hear from other sufferers, and to support one another. i have had IBS for 20 years. nothing worked until Lotronex. after i found i couldnt fill my script yesterday, i cried as if a life had been lost (which is really how it feels). my last dose was yesterday morning, and i'm anticipating that first D. i dont want to live like that again. I was grateful every day to have normal bowel movements. i took one Lotronex twice a day and had only minimal 'C' once in a great while. no biggie! in fact, it was a pleasure experiencing it - i'd never been C'd before!i wrote to the FDA and Glaxo, both jointly responsible for the withdrawal. the more they hear from us, the more chance we have to get lotronex back on the market. its encouraging to hear of everyone's efforts. stand up and say, "hey, we dont need this s**t!" (literally)


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## SteveE

I'm rather amazed at the out-pouring of sadness here. I mean...I guess I didn't get the impression that Lotronex was helping that many here. As a Lotro-outsider, I guess I have mixed feelings. My doctor offered it to me, but I was (yeah, you guessed it) skeptical and wanted to wait and see. When I first heard the alleged horror stories, I was glad I declined to take it. Now I'm just confused. But I certainly understand the positions I've read here...especially the one relating to smoking. That stuff is clearly responsible for sapping this country of precious medical resources and driving-up insurance rates while our politicians debate how to save medicare (hmm). Yet you have drugs that help people which may or may not have negative consequences that have to pulled from the shelves??? Sounds like Glaxo is covering their collective butts...too bad we couldn't tobacco companies to cover THEIR butts so I don't have to breath it everytime I walk between buildings!


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## Throne King

I'm with you all on this.Right now I'm looking into how to contact the FDA and Glaxo by email.I spoke to Glaxo earlier by phone and they are swamped in calls with 50 people manning the phones.Dreading my return to the porcelain prison.------------------King of the Throne


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## JuliaNYC

Jeff, thanks so much for doing the press release. I hope the media will pick it up; our (the successful Lotronex users) side of the story has been missing from every print and TV/radio article on the Lotronex withdrawal. Lotronex gave me my life back, and from what I've been reading here, I'm not the only one.


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## trbell

seems to be a lot of energy generated here but maybe it should be focused on the real problem - profit motive in health care:Money May Taint ResearchPolicy Loopholes Don't Protect Patients in Clinical Studies headline from abc news from the associated press from the New England Journal of Medicines study of drug trials - this whole thing was a mess from the start


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## Guest

I just wanted to respond to the many posts from individuals who are so upset about this withdrawal. I'm one of those people who thought Lotronex was a miracle. I had diarrhea for 40 years....not D & C, not C, just D. I was the perfect candidate for Lotronex. I took it for almost three months and was in heaven. Because it did have a tendency to be constipating, I took only 1/2 tab once or twice or day. I had no problems that I knew of with the drug. It was wonderful (I thought), until I ended up spending a night in the bathroom with debilitating cramps, no BM, a high fever, chills, and non-stop vomiting for about five hours. At that point, I called my GI doc who advised going to the ER. I was hospitalized for several days.Exactly one year before I had had a colonoscopy....no abnormalities. In the hospital I had another colonoscopy which showed numerous ulcers and clear signs of Ischemic Colitis. I had been to the doctor on Friday...we both thought my response to the medication was great....I was hospitalized early Sat. morning. The reason I'm reporting this is to emphasize that it wasn't a matter of having problems with the drug and not being smart enough to stop it. I did not know that anything was wrong in my response to the medicine until I was in very serious trouble. As you no doubt know, Ischemic Colitis is the result of the bowel being deprived of blood flow and it dies. Gangrene then develops, and the outcome if not caught in time is death. I had many problems while I was taking the medication, but because they were seemingly unrelated to IBS, I had no idea (and neither did the four doctors I saw) that the medication was causing the problems. I had daily migraines, chest pain and back pain (which resulted in hospitalization 10 days before the IC hospitalization), a cough when I ate and tried to sleep, and erratic blood pressure.....on one hospitalization it was 209/94. My typical blood pressure all my life has been 120/70. Again, I saw multiple docs and specialist during this two month period and none of them realized it was the Lotronex even though they all knew I was taking it! Since stopping the Lotronex, all the above symptoms have gone away. My blood pressure is still a little higher than normal (###145/81), but not a problem.One of the things I've noted on the various boards over the past two months is a seeming tendency by other IBS sufferers who love their Lotronex to blame the patients who have had problems with Lotronex. I have received very hostile e-mails from people who me and/or my doctor for taking the medication inappropriately. For someone like me, who is intelligent, educated (Ph.D.), and informed, it is insulting to be blamed for taking the medication irresponsibly or to having been prescribed the medication inappropriately. This absolutely was not the case. Anyway, sorry to be so long-winded. I just felt you might need a few more facts before assuming that Lotronex is really that miracle drug we all want. Faith


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## Missycat

Thank you for posting, Faith. Your story is one that we all need to see. We've never heard it from the side of someone who was taking Lotronex responsibly, being monitored for it responsibly, and still ended up with unforseen problems.------------------Fear can hold you prisoner.......hope can set you free.*Missycat* >^.^<


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## Guest

Faith:Thank you!!!!LOLTake Care,Julia41


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## babydoc_au

I'm sorry to hear that so many people have been deprived of a treatment that appeared to be working safely and effectively for them. This situation reminds me a little of a situation that occurred with a drug for schizophrenia called clozapine. It was first released about 20 years ago, and was found to work in treatment resistant schizophrenia, with less side effects than other anti-psychotics. It was the only drug in its class, not unlike Lotronex. Then a number of deaths occurred which were directly attributed to the drug. It caused problems with the white blood cells, called agranulocytosis, which reduced the bodies potential to deal with even simple infections. Anyhow, the drug company withdrew it, but kept working on it. It was able to be re-released years later under strict protocols. This includes prescription only by psychiatrists to ensure it's given to those best indicated for it, careful blood monitoring and regular medical reviews. Also, education to the clients to identify warning signs of serious side-effects. This drug makes a vast difference to the lives of many people who don't respond to other anti-psychotics. It is possible that GlaxoWellcome will be able to find a safe monitoring method in time to check for early signs of ischemic colitis.Since clozapine was re-released other companies have formulated similar drugs that work in a similar way but with less potential for the serious side-effects. Hopefully this is what we will see with Lotronex.So it's not all bad - try to stay positive until new drugs appear, and keep writing to the FDA.GOOD LUCK


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## DigestDan

I am new to the board, and just sent my concerns about the withdrawal of Lotronex. I am the first individual quoted in Mr. Roberts' press release.I have been upset and disappointed about the sudden withdrawal of Lotronex. I have a limited supply, and am thinking that I will continue with it, perhaps cutting down my dose, until my supply is gone. Hopefully, another alternative will develop in the next few months.I have taken the following steps, and urge everyone reading this to do so:1. Registered and posted to this board2. Called Glaxo Welcome by phone to register my feelings. They took my name, number,and said they have been getting many, many calls.3. E-mailed to the FDA at:jhenney###oc.fda.gov4. Called my own doctor. (He didn't have any great ideas or suggestions, besides switching me to Librax....)I am hoping that working together we can at least show our concern. Perhaps we can prompt either limited approval of Lotronex or at least show the need for quick approval of some related substitute.


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## Joanie65

You can add another person to the list of unhappy people. Lotronex has been a miracle for me. I am dreading the last day of taking it knowing there is no more available. I too have sent an email to FDA and also to 20/20 and have friends sending emails for me also. Yes, I am saddened at the people that have had complications and have died. That is terrible!! But, and this has been said before, not all medications work for everyone. There are other medications on the market that have caused complications and even suicide and those prescription medications are still on the market. Now what is the difference? I don't understand. You can count on me to continue to try and get Lotronex back on the market. Good luck to us all!


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## BQ

Faith, Ok, you're scaring me now. I am taking the Lotronex for the very same type IBS symptoms, in very small doses(1/4 of 1mg)just like you were, it was & is working like yours was. Let me review those IC sypmtoms one more time; migraines, elevated BP, coughing when eating or sleeping, back and/or chest pain. Have I got it right? Cause I will definitely be looking out for those symptoms if I continue to take it. I'm not so sure I should now that I've read your story. Thanks so much for sharing your experience with us. Who knows how many people you may be helping by telling us just how fast IC can show up. I was under the mistaken impression that it would be Obvious if one had IC. Evidently that is not necessarily so. You are the evidence of that. I can't thank you enough for your post. Maybe I shouldn't take any chances and stop taking it now, especially since I was putting up with a bad gall bladder for at least 18 mos. until it too was gangrinous. Dr.s didn't think I fit a bad GB profile and misdiagnosed my pain as back spasms. Anyway you have given me serious food for thought and I thank you again.So glad you are alright. BQ


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## Guest

You're welcome. I simply feel that there needs to be a voice from someone who experienced problems. I have been in e-mail contact with many, many women who have had problems. One woman's Mother died as a result. You have listed the problems I had correctly. There have also been reports of serious bladder infections which I did not have. I agree with the respondent who discussed clozapine. Perhaps refinements can also be made to Lotronex to make it a safer product. As happened to me, you can be very sick and not even know it. Many women I have heard from took the medication happily and thankfully for several months before becoming seriously ill. I would probably have been one of those people petitioning to keep it on the market if I hadn't suddenly ended up in the hospital. That is the most frightening aspect of this whole controversy over the withdrawal. I am just afraid that many others are sick right now and don't know. Faith


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## Bud

Faith, thanks soooooo much for your post. I wasn't sure how it would be received when I saw it earlier today, but as always, the members came through again with words of praise which is what you deserve. Actually, it felt good to hear from a real person about the problem side of lotronex because it gives more credibility to the problem than all the articles I have read, which always seem to be biased. Your message has also given us (my wife's the one with IBS) a keener awareness of the possible problems.On the flip side, I offer to you that lotronex has been god send for many suffers. Also, I'd like to believe that most users are aware of the risk. And, given the risk versus reward, they have chosen the risk, with the key word being chosen. You see, for my wife and probably most others, a handful of strangers who most likely have never suffered from IBS have made a decision to take away our right of choice and that's what's appalling.Please don't think I'm attacking you because that's not my intent. I am very sincere in thanking you for bringing forward your experience. All I ask is that you try to understand that for many/most, lotronex has given them back their lives and that our argument is about choice .... Our choice.As a final note, my wife has been cramping big time every since she found out about the withdrawal yesterday and she hasn't had steady cramps for two days since she started lotronex. She's scared .... Really scared of what lies ahead. And I've read many posts relaying the same fear and it's tearing my heart out.I hope that you will understand.


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## trbell

rather than blaming I wonder if something constructive can be made out of this. I don't see how the FDA could be blamed except for releasing latronex too soon and letting it be given without safeguards. This will probably affect the release of Zelmac - which is the one I'm waiting for.tom


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## kati

Faith,Your experience with Lotronex was scary. My doctor gave me Lotronex several months ago and I used it for a month and it didn't work for me. I was wary of it anyway, knowing it was new to the market, but was willing to try it to alleviate my D-problem. It is sad that several people have died as result of taking this medication. And I sympathize with the people who have been taking it with good results and know how very upset they must be to have the medicine taken away. [This message has been edited by kati (edited 12-01-2000).]


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## Guest

I agree with you that many women seem to have been greatly helped by this medication. I would have classified myself in that group not too long ago. What I cannot understand is Glaxo Wellcome's unwillingness to accept a compromise to allow this drug to continue to be used by people who are severly impaired by this drug. On the LA Times web site there are three articles written today and yesterday. Following are a couple of quotes:. "At a Tuesday morning meeting, FDA gave Glaxo the option of restricting Lotronex sales to just a few women with severe IBS who are treated by specialists, said FDA's Dr. Victor Raczkowski. Such restricted sales are used with a few other risky drugs, such as thalidomide and Accutane, notorious for causing birth defects. Glaxo's chief medical officer Dr. Richard Kent called the option unworkable, and said FDA's response was then to order Lotronex banned. Raczkowski denies that, calling the withdrawal of the drug Glaxo's own decision." .......A second article stated: ï¿½"The end for Lotronex came Tuesday during a 2 1/2-hour meeting convened privately at the FDA's headquarters in suburban Rockville, Md. According to those familiar with the session, Glaxo executives, led by company Chairman Robert A. Ingram, reiterated their position that the risks of Lotronex could be managed adequately through revised labeling and other measures. Agency officials recommended that Glaxo either withdraw the drug or agree to controls that would restrict sales of the pill, once regarded by Wall Street as a potential blockbuster. ï¿½ï¿½ï¿½ï¿½ï¿½"We said to the FDA, 'Look, these [proposed controls] are no-gos. We believe you're asking us to remove the drug,' " said Dr. Richard S. Kent, Glaxo's chief medical officer and vice president. " 'So, we are going to remove the drug.' " ï¿½ï¿½ï¿½ï¿½ï¿½This compromise offer makes sense to me....does it to anyone else??Faith


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## Miss Patience

Faith--thank you for your story. I'm sorry you had to go through that. However, I would also like to agree with Bud. Life is full of risks to take, and this is one I was and am willing to take, because for me, the reward is so great. Even though the complications are serious, the chances of having them are relatively small. Smaller than the chance of being in a wreck on the way to work, probably. I know it doesn't seem like a small risk to you, and I'm sorry for what you went through. Is having NO risk an attainable goal? I don't know. I don't believe it is.After reading all the press releases, with the different sides to the story, I have to believe profit is behind this, to at least some extent. Glaxo decided they couldn't make enough MONEY with the restrictions, so it was no longer worth it to them. As patient, I would have jumped through the hoops, seeing a specialist, etc, etc. But IMO they decided it would hurt their bottom line. And that's too bad.Colleen


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## JJKWright

I'm trying to look at all sides of this too. Surely if a drug company can create a drug like this, they are capable of reformulating it so it is acceptable and safe for everyone concerned. I have felt from the beginning that it is a very powerful drug. After all, nothing else has worked in the 19 years I've had IBS. I still believe the problem is in who it was prescribed for and in the correct dosage.


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## Missycat

JJKWright - I work in the pharmaceutical industry, snd it is darned near impossible to retool a drug to "make it safer." In most cases it can't be done. Even if Glaxo went back to the drawing board, they would have to go through drug development, Phase I, Phase II, and Phase III trials and FDA apporval all over again, which takes years. If Glaxo has disappointment over low revenues with Lotronex now, they would never go through all of the millions of dollars to bring another Lotronex-type drug to market, because it doesn't make economical sense for them.There's a lot more going on here than whether or not FDA and Glaxo could accept each other's proposals.........------------------Fear can hold you prisoner.......hope can set you free.*Missycat* >^.^<


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## Guest

I am sitting here in tears as I read about everyone this drug has helped, including myself. I just can't believe that the one thing that has given so many people relief is gone. I have tried several different drugs to no avail. Lotronex has been the only thing that has allowed me to reclaim my life. Since none of the other IBS drugs has worked my Dr is now starting to see if anti-depressants will help. I am very discouraged and very angry over this development.


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## Guest

Faith:Thank you so much for your post. I read it with great interest.Lotronex has worked so well for me, I can't imagine going back to life before it. But unfortunately, after several telecons with Glaxo and my doc, it appears that's inevitable. As much as it pains us all to go back to the daily struggles of dealing with IBS-D, if we keep telling ourselves it could be worse, perhaps, somehow we'll get through each day.I will, however, continue to do whatever I can to get Lotronex back on the market, as nothing has worked better for me in over 20 years.Thank you all for your posts. Staying educated on this matter can only help us.Take care.One Day At A Time------------------Female (IBS-D)- On Lotronex since 3/00 - current dosage 1/2 pill daily - Doing great!!!


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## bobk

I can't beleive that it has been taken off the market. I do not know what I'm going to take in place of it. I got a call from two pharmacy that I filled Lotronex at. I got a call my Gastro Dr today to tell me to stop taking it. I take 1 pill a day and I have a lot of pills still left. This is the only thing that has helped me for the last 20 years. I was in the trials at the end of last year and have been on the drug for almost a year now.


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## jackson

For all of us who were helped by Lotronex, there are things we can to do make our voices heard.The phone number for Glaxo Wellcome is 888-825-5249. They are logging phone calls from Lotronex users.The people to contact at the FDA are - Jane Henney, M.D., Commissioner, FDA Janet Woodcock, M.D., Director, FDAFDA - Dockets Management BranchDepartment of Health and Human ServicesRoom 1-2312420 Parklawn DriveRockville, MD 20857You can also write the following people at the Public Citizen Health Research Group who are greatly responsible for the FDA's decision to remove Lotronex from the market:Elizabeth Barbehenn, PhDResearch Analyst Peter Lurie, MD, MPHDeputy Director Larry Sasich, PharmD, MPH, FASHPResearch Analyst Sidney M. Wolfe, MDDirectorHealth Research GroupPublic Citizen1600 20th St. NWWashington, DC 20009Please take the time to let these people know how they have affected the quality of our lives and how we will suffer because of their decisions on this issue.


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## Guest

I have just read the news about lotronex on the BB this morning, we in the UK have been waiting (im)patiently for the licence to be granted to allow marketing in Europe for lotronex, which is obviously not now going to happen.I am not a conspiracy theorist, but a review of the FDA and Glaxo's press releases (both of 28 Nov) seems to reveal that the FDA were prepared to let Glaxo continue marketing lotronex under strictly controlled conditions, but Glaxo weren't prepared to play ball if they couldn't have full approval. To quote Glaxo: "Glaxo Wellcome takes a different view from FDA on the ability to educate physicians and patients about the management of potential side effects and benefits of Lotronex"... clever use of language. My guess is Glaxo knew the hysteria that would result now that people are now psychologically dependent on lotronex, because of the horrible anti-social nature of this illness. Not surprising, given that only 70 'adverse events' (FDA description) have arisen out of 450,000 prescriptions (Glaxo statistics) ... not to mention the reactions on this BB of those for whom lotronex has literally been a life saver. Faith's story is disturbing, of course, but she also recognizes that lotronex did not need to be removed altogether.For the rest of you, my heartfelt wishes that this situation will be satisfactorily resolved in the very near future .. ideally by a drug company who develop a medication that they won't try to hold people or government agencies to ransom over.Good luck allKari


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## Calle

I am new to this web site and I have been reading all of the posts out there from everyone like myself that is outraged over the FDA pulling Lotronex. I have e-mailed Glaxo Wellcome and received their response. I have e-mailed the FDA and I will e-mail ABC news and whoever else I need to, to get the word out. I am so proud to see the team work going on right now to do something about keeping this drug on the market. It will take this kind of pressure from us for the FDA to listen. I talked to my Doctor and my pharmacist and they do not agree with what the FDA did. My God, there are so many drugs on the market that can potentially have serious side effects, like the birth control pill to some people and they don't take that off of the market. People have got to take responsibility when they take prescription drugs. It only takes common sense to cut back on the dosage if it's too much.We all need to stand together on this and I will do whatever it takes to help. I have suffered from IBS for the past 20 years and FINALLY a drug like Lotronex comes a long and changes my life. This isn't fair.God Bless all of you and lets fight the FDA on this until we get this back on the market!


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## Guest

You write, "My God, there are so many drugs on the market that can potentially have serious side effects, like the birth control pill to some people and they don't take that off of the market. People have got to take responsibility when they take prescription drugs. It only takes common sense to cut back on the dosage if it's too much." I want to reiterate that Lotronex appeared to be working for me with NO PROBLEMS as to IBS. I took 1/2 tab once or twice a day and none when I did not have a bowel movement that day. I was not IRRESPONSIBLE. However, your comments are the height of irresponsibility. Perhaps you could attempt to be more insightful and NOT blame people who have been injured by this drug. I realize it is difficult to be objective when you suffer from something as debilitating as IBS, but I must react to your unfair characterization of others.


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## Stace

This whole Lotronex deal reminds me of the Fen-phen deal a few years ago. I am wondering if they were ever able to bring that drug back in a formulation that was less risky? Does anyone know? If so, that would give one hope for the same to happen with Lotronex. My heartfelt thoughts are with all of you who will suffer from Lotronex being pulled off the market as well as those of you who suffered from the effects of this drug. Stacey


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## Guest

I'm male and had very limited success with Lotronex, but it seemed to be the only effective drug for me, even though only mildly helpful. It can work on men and I wonder how may male fatalities or complications have been recorded. Probably not many. I do take comfort in the fact however, that I'll be keeping that $130. I was spending every month. I too am surprised by the number of BB'ers who had success with this drug. I don't remember seeing posts of this much praise when it came out.brian


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## Guest

Faith's right. It was one thing when they said Lotronex could cause problems in people who have or had ischemic colitis. That would be a responsibility issue. But the fact that it could cause that disease, I don't think any drug is FDA approoved if prooven to be the cause of the problem.brian[This message has been edited by bkritter (edited 12-02-2000).]


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## jackson

Faith,While I understand that you would blame your problems on Lotronex, it is not clear, at least through your post, that it was proven with certainty that Lotronex was the cause. I doubt that it could ever be substantiated and that, of course, must be frustrating to you. It is obvious that you would not choose to resume taking Lotronex. However, you can see how the vast majority of people who have taken it with little or no side effects, and likely would have none in the future, would feel otherwise.


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## Jeffrey Roberts

For anyone who didn't see my posting I have created an on-line survey about Lotronex.You can find it on www.IBSwatch.com


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## Guest

Faith,Thank you for your helpful posting. I certainly do not put any blame on you or others who have reported what appears to be significant side effects of Lotronex. Even though not proven by large numbers or a study, the side effects that you believe were a result of Lotronex are certainly impressive, and in the case of the colon lesions, terrifying. It is equally impressive that the symptoms all disappeared when you stopped the Lotronex.What impresses me is that you had so many significant sounding symptoms and nobody wondered if your new medication (on it 3 months) was related to any of these. It is very common to develop side effects after several months or longer, of a drug; it doesn't have to happen immediatly on starting the medication. Would it have been a big deal to stop the medication for a few days, or even a few weeks, to see if these new symptoms that you had would resolve? Was Lotronex the only drug you were taking?I'm quite interested as I have a supply of Lotronex (which has worked well for me, a man) that I intend to use. Certainly if I have any significant symptoms of any kind, even different from yours, I would suspect Lotronex and discontinue it.


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## Guest

Faith:I read with interest your post and incident. May I ask your age? (I know it's not polite to ask a woman her age, but am curious as you said you had IBS for over 40 years.) If you're uncomfortable answering, please excuse the question.Does anyone know if we can get specifics about each of the incidences that the FDA is referring to? For example, what was the exact cause of death, how old were the patients involved, how long had they been taking Lotronex, what were the symptoms leading up to their hospitalization and eventual death, why the FDA believes their deaths are associated with their taking Lotronex, etc. I would like to know the same about the people who had incidences but only required hospitalization or surgery.After talking to Glaxo several times and reading the posts here, I agree with another earlier post that Glaxo is worried about their bottom line. If the FDA truly did not want Lotronex taken off the market but wanted only more restrictions placed on the drug, then Glaxo withdrawing the drug from the market was probably due to the fact that they would not make much money on it with those restrictions, therefore, why bother. Maybe they're hoping with all the hoopla about the withdrawal, the FDA may back down and allow its use under less stringent restrictions. Who knows, really. I get different stories from each end.Anyway, I digress. It would be very interesting if we could get specific information on the patients who were adversely affected, although I don't know how to go about doing that, or if it's even possible due to patient confidentiality reasons. If anyone can answer, I'll look forward to your response.------------------Female (IBS-D) - Think Positive!!! It could be worse!!!


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## Guest

Thanks for the positive responses. As to the question of stopping the medication. My immediate response to Lotronex was so positive and the other problems I was having were seemingly so unrelated to IBS and its symptoms, that no one--including the four docs or me--tied it to Lotronex. Think about it.....if you have a history of migraines (which I do because of a car wreck) and they increased for no apparent reason and the Imitrex which had been helpful was not as effective....resulting in migraines coming back in the afternoon, you would see your primary and likely a neurologist....I did that. The approach there was to change my migraine medication. Every doc I saw knew I was on the Lotronex. My primary physician spent hours on line trying to figure out why I was so sick all summer. I went to the GI doc following up twice in the three mos I was on the Lotronex. (I am a long-term patient with this physician.) He thought the cough (after eating and at night) was GERD. He gave me medication for GERD and it did not help. He ordered an endoscopy--but I was hospitalized before it was scheduled to occur. I started having chest and back pain and was hospitalized, and the diagnosis was costcochondritis (inflammation in the sternum)...I have arthritis in other areas so that did not seem unreasonable...At the time of that hospitalization, my BP was 209/94....they thought it was so high because of pain. Later it was 170/100 when I was attending an art festival and felt "odd." I went back to the doc and it was not as high...so it was still assumed that it was caused by pain. When I was hospitalized with IC, the blood pressure was 194/94 and they assumed it was pain related again. Within 2-4 weeks of being off the Lotronex, all these symptoms are resolved. Ok....since hindsight is 20/20, the picture is now clear....but I was doing GREAT on the Lotronex. I loved it! Maybe I should have been cognizant of the tie-in, but I wasn't. Perhaps everyone else would have been, but I suspect that those of us who have had IBS for most of our lives and having taken every drug imaginable for the symptoms would have just been thrilled with the Lotronex and never suspected it. I tried to correspond with Calle off the board to let her know of my reaction to her "blaming the victim" approach. Unfortunately, the response was as follows:"I am not the only one that feels this way. There have been other posts on the IBS board that have expressed the same feelings as mine. I can't help it that some people are not better monitored by their doctors when taking prescription drugs. I also had problems when I first started taking Lotronex. I cut back on the dosage and I go some days without even taking it and that seems to work out fine for me. So now I have to pay for what happened to the other people that had the serious side effects from this drug. I am sorry that people were hospitalized and some people died from this drug, someone needs to take responsibility for this...is it the Doctors, the FDA, Glaxo Wellcome? What about the people that truly benefited from this drug. I guess so what for us? As a grown adult I take responsibility for my own health. If you feel I demonstrate ignorance to this situation, I guess that is your problem and your opinion!"Oh, well, ignorance is bliss, I guess. It must be nice to feel so confident. I do not blame my doctors. They are competent, caring, and were very involved in my care. Again, I apologize for being so long-winded, but was trying to clearly answer your question. Hope that has been accomplished.Faith


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## Guest

To: One Day at a TimeThe answer regarding my age is 58. I have had the symptoms of IBS since I was a teenager. Of course, back then it was not called IBS, but for many, many years now that has been the diagnosis. I do not have problems with constipation....just diarrhea that usually occurs for 4-5 hrs in the morning--this was very fortunate for me professionally. When I was working (I'm a Clinical Psychologist), I would get up very, very early and would not schedule patients before 11 a.m. and then would work til 7-8 at night. That way I was able to function professionally. Of course, with IBS, an "attack" can strike any time, any where...so that was a problem, but you learn to just cope. Hope this answers your questions. Please fill free to correspond with me by e-mail if you wish.Faith


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## Guest

Just a thought. I am in correspondence with many women who have suffered greatly as a result of taking Lotronex. They are extremely reluctant to go public because of people who blame the patient for taking the medication incorrectly or irresponsibly or the doctor for not properly monitoring the drug. They are fearful for me because I have "gone public" and used my name. Maybe they're right to protect themselves from attack. I have also received extremely hostile e-mails attacking me for being such an "idiot" and for "trying to take away other's Lotronex." For those of you who are more rational, I hope you realize that my goal is to just provide more information and perhaps a different point of view. Faith


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## BQ

Faith, You go girl!!!! I don't know about anyone else, but I DO hear what you are saying. I was in the same position with my gall bladder in March. I went to my physician who I trusted & still trust with this severe "back spasm" several times over a 18mos to 2 year period. I had vomiting with these attacks and he knew that. But with two school age kids in the house who sometimes were sick while I was having these attacks, of course it was easy to assume it was a virus or something else they brought home. There were so many things that masked this bad GB. He didn't catch it. I'm pretty stoic when it comes to pain and maybe I didn't express the pain clearly enough. But you know, if one hasn't had something like this happen to one, I don't think one can truly understand that SOMETIMES THINGS JUST HAPPEN. With the best Dr.s, the best technology, the best medicine, etc. things can still go wrong and illnesses can be missed. I don't blame my Dr. I don't blame anyone. Was I in serious trouble? You bet. The surgeon said I wouldn't have made it thru the night without rupturing. Yeah it was close. But eventually it WAS caught and taken care of in time, thank God! I harbor no ill feelings toward my Dr. and I still trust him. And yes, when it happened I told people what my symptoms were and two of those people had similar symptoms to mine and both of them had their GB out within 3 weeks of my surgery. So, things are missed fairly regularly but I don't think they are totally missed very often. When our bodies say something, we should listen and tell our Dr.s as clearly as we can. Help them help us. But no one is perfect and illnesses are not caught on the first try always. But that is life. All we can, anyone can do is their best. And still THINGS CAN HAPPEN, its part of life. Thank you AGAIN for sharing your symptoms, your story. YOU HAVE HELPED PEOPLE and I am grateful for you! BQ


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## Rosy

I am also someone who had adverse results with lotronex. However, I can't take penicillin either. I have allergic reactions to many things and my doctor thought I was having one to lotronex. I didn't expect to have such a reaction and the only way to describe it is I felt like I was going to die. It seemed to occur in my brain and to a lesser degree all over and I really can't describe the strange feeling but it only occured each time I took lotonex and I only ever took two tablets. I won't take another but I won't take penicillin either. Some people will always have have adverse reactions but then many others may be helped by the same med. We are all different and have to figure out what works for each of us. I only hope we can all find a solution to this baffling IBS.


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## Guest

Faith has shown tremendous courage by stating publicly that she has suffered adverse effects as a result of Lotronex. She is not alone. I am an attorney who has represented hundreds of people from across the US and Canada in prescription drug claims. While many of you have benefited from Lotronex, you must realize that many others have suffered. For those who I now represent and for others who will contact me in the future, you have a right to be represented if you suffered injuries as a result of taking this medication. For a confidential consultation, feel free to call me toll free at 1-800-500-0729


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## jobabe56

Faith, Sorry to hear you had problems while on Lotronex. I have a few questions as I too experienced the same symtoms as you but only twice during the first two months after starting Lotronex.Mine weren't as severe as I had a BM after an hour or so, although I thought I was dying at the time. Afterwards I was fine and haven't had an episode since. I have been taking 1/2 tab daily now for 8-9 months. I have quite a bit of medcation left which I have no intention of parting with, but I must admit your post has put somewhat of a scare in me. My questions: Did you take any kind of fiber? Did you have regular daily BMs?Are there any tests that can be done to monitor signs of Ischemic Colitis? Thanks for explaining what exactly IC is. I had no idea. I will appreciate your response. Good Luck to you. Jo


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## Guest

I never thought I could cry over something like this! If my husband wasn't here, I would have more than tears welling in my eyes. And, to read the other messages here makes me even sadder to see how many people this is going to effect.I have been taking Lotronex since it was available on the market. What do I do now? Life before Lotronex is not something I look forward to repeating. I didn't realize Lotronex was taken off the market until this morning. Not sure what hole I was hiding in to have missed it. (I certainly wasn't in the bathroom with IBS!) I put in for a refill at the drug store yesterday - guess that was useless (but I didn't know anything at the time).Lotronex was a godsend for me. It didn't cure me 100%, but it sure did make me feel a whole heck of a lot better than I did before I started taking it. So, now I need to call my doctor and see what I can take in its place. I already take Loperamide for those times when my IBS kicks in for a short visit. I did take Buspar in the past, but I'm not sure how much it helped. That was B.L. (Before Lotronex).I wonder what it will be like going cold turkey - stopping Lotronex immediately - I wonder how much "fun" that will be...


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## punkie19female

My life was great when I started using Lotronex. I have no idea what I'm going to do now. I cry just thinking of the pain I'm going to get again. I only have a month supply left. I just cry thinking of not being able to take Lotronex. This is going to ruin my life. This is so sad for so many people. I thought I was all alone until I met this website.


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## punkie19female

This is very sad news for many people,including myself. Lotronex has helped me so much the past six months. I cry just thinking what my life will be like without Lotronex. I only have a month supply left. My heart goes out to everyone.


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## Guest

This is a response to "jobabe56" above. I had a BM every morning....if I didn't, I just didn't take any L. until I did....all but the last time it was the next day. I have never done OK taking fiber....always end up with even worse cramping and did not take it while on Lotronex. Did not appear to need it. When I was discharged from the hospital, the doctor advised me to watch for bloody diarrhea and abdominal pain. The only way to really know if you have IC is to actually look into the bowel (ex. colonoscopy). The doctor advised to drink a lot of water....apparently staying well hydrated is very important. I hope this info is helpful. Faith


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## tracey

Here is the info as I have it so far. Lotronex is approved for marketing in Mexico, Argentina, South Korea and one other country I can't remember but (as per a Glaxo representative) they will never market the drug. So going to a foreign country is out. I have tried to obtain any I can via on line pharmacies as my pharmacy refuses to fill any more prescriptions but all the pharmacies I tried refused me. I feel like a drug addict counting my last pills with abject fear of the day when I have no more. I have e-mailed Dr. Wolfe with absolutely no replies. Does anyone wish to stop taking their lotronex and sell it? I will buy it. I hope Ralph Nader one day faces a horror in his life like what he has subjected me to.


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## Bean69

Tracey I feel the same way! I have only had the D-type IBS and Lotronex was truly a wonder drug for me. Ralph Nader's group is an idiot net. The safety warnings were clear. I am not against pulling a drug that may have risks, but this worked so well for so many people that you just know some folks were getting scripts with both types of IBS. The doctor's that prescribed should have known better!!


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## tracey

This is an additional message specifically regarding Faith and her reaction to lotronex. I am a doctor as well as an IBS sufferer. Listening to Faith's story initially made me think twice about continuing lotronex but then the medical side of my brain kicked in and I began to think about why she developed ischemic colitis. This disorder is believed to arise in areas of the bowel considered "watershed" - in other words not well perfused by collateral blood vessel circulation. That is why it is often a disease of the elderly with arteriosclerosis. Perhaps Faith had abberant GI perfusion - everyone's anatomy is different- this would not be picked up on GI testing - and that is why she suffered from ischemic colitis. Perhaps this contributed to her IBS symptoms as well. What I am trying to say here is that one person having an adverse reaction can mean that they fall out of the Gaussian distribution of normal for what ever reason. (for you statistics buffs out there). Even if 27 people (out of the 500,000 prescriptions that Glaxo claims were written since the approval of lotronex) had ischemic colitis, they would not represent the normal population. The FDA would not allow an independent group of researchers to examine the data (Glaxo specifically requested this). I think this is what we should push for and really need.


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## Guest

I have emailed both the FDA and Glaxo as well as called them.This is horrible news. I was able to take this medicine just fine by taking one tablet when I got into trouble.I finally had a life back!!Glaxo needs to work with the FDA to re-release this medicine!!!!!!!!


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## Bud

Tracey, thanks for your comments. I too read Faithï¿½s post and had to give some thought to the risks involved with lotronex. Hers was an eye opener with what I felt was a great amount of credibility. But, like you, itï¿½s an issue of risk versus reward as well as choice, or in this case, lack of choice.With regard to Glaxo, what you said about the FDA not allowing an independent group of researchers to examine the data is what Iï¿½ve gotten in a personalized e-mail from Glaxo (personalized, but a lot was cut and pasted boilerplate). They also stated that the FDA asked them to withdraw lotronex. Remember that the government controls and when they ask a company to withdraw a product, what they are really saying is that the company can do it voluntarily or they, the FDA, will do it for them by ordering mandatory withdrawal. If what Glaxoï¿½s saying is true, their voluntary withdrawal was the only intelligent business decision that could be made.Iï¿½m sorry, but I just donï¿½t trust government, but then I know thereï¿½s two sides to this story. The reality is, we are stuck in the middle with the powers-to-be treating us as the little people again while they shield themselves from us as if royalty while protecting us idiots from ourselves.[This message has been edited by Bud (edited 12-04-2000).]


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## Jeffrey Roberts

http://www.prweb.com/releases/2000/prweb20780.htm IBS Self Help Group reacts to withdrawal of Lotronex by Glaxo WellcomeMany Lotronex users view the withdrawal as having a very negative impact on their livesTORONTO, Ontario, Dec 4 - The Irritable Bowel Syndrome Self HelpGroup, (www.ibsgroup.org), has received an unprecedented number ofrequests for help from Lotronex users due to Glaxo Wellcome'sannouncement that, at the request of the US Food and Drug Administration(FDA), it will voluntarily withdraw Lotronex, its treatment for irritablebowel syndrome (IBS), from the US market. Many have written thatthey have been driven to despair and cannot imagine going back to theway it was prior to taking Lotronex.A member of the IBS Self Help Group wrote "I am one of many peoplewhose lives were changed when I tried Lotronex. This is afterliterally 30 years with IBS. Nothing worked for me, and I had triedit all. I remember the feeling of let down I had every time I left thegastroenterology office, and I was given nothing knew. Lotronex radicallychanged my body and my life. I became more sociable and responsible atwork, enjoyed eating more, and had a rosier future when I planned tripsthat I would not have taken otherwise."Members of the IBS Group have written to the FDA and spoken directlyto Glaxo in an effort to tell them the positive effects of the drug.Many write that with the right adjustment to their own dosage of Lotronexthat they were able to prevent, or control, the primary side-effect ofconstipation. The Public Citizen, a nationwide consumer organizationwhich petitioned the FDA to remove Lotronex from the market, suggestedto the FDA that "the adverse reactions tip the risk-benefit equationagainst using the drug." They characterized IBS "as a poorly defineddisease although capable of causing significant distress in someindividuals," which upset many members as being very dismissive ofan illness which affects their everyday life.The IBS Self Help Group undertook a Lotronex survey on IBSwatch.com(www.ibswatch.com) to capture members experiences with the drug andtheir reaction to the FDA's request to have Lotronex withdrawn. Surveytakers overwhelmly indicated that they benefited from Lotronex andoppose Glaxo Wellcome's decision to withdraw Lotronex."I understand that expert counsel from a number of gastroenterologistsbelieved that Lotronex had an unacceptable risk/benefit ratio and thiswas taken into consideration by Glaxo prior to voluntarilywithdrawing the drug," said Jeffrey Roberts, President and Founder ofthe Irritable Bowel Syndrome (IBS) Self Help Group. Mr. Robertscontinues, "The withdrawal is a regrettable situation given the apparentthousands of women who have benefited from Lotronex. Safety is paramountand must always be considered, however, I urge the FDA and Glaxo tocontinue discussions about Lotronex and make decisions for or againstthe use of it in the face of further investigations."About the Irritable Bowel Syndrome (IBS) Self Help Group:The IBS Self Help Group is the premier internet self help health siteabout Irritable Bowel Syndrome, with more than 200,000 Bulletin Boardmember postings about the functional gastrointestinal disorder IrritableBowel Syndrome and largest provider of health related information forsufferers of IBS.The IBS Self Help Group (www.ibsgroup.org), formed in 1987, is insupport of those who suffer from IBS, those who are looking for supportfor someone who has IBS, and medical professionals who want to learnmore about IBS. The IBS website was launched in May 1995.The IBS Self Help Group website provides access to bulletin and chatboards, book list and store, medication listing, clinical studylistings and helpful information. All revenues from sponsorship,affiliation and donations go directly to funding the activities of theIBS Self Help Group. The IBS Group has several sponsors which assistin supporting the group's activities. Sponsorship information isavailable at http://www.ibsgroup.org/main/sponsor.html ###Contact:Irritable Bowel Syndrome (IBS) Self Help GroupJeffrey Roberts, President and Founderibs###ibsgroup.org http://www.ibsgroup.org[This message has been edited by Jeffrey Roberts (edited 12-06-2000).]


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## Guest

Hi everyoneI just received an email awhile ago from the Medscape people. I was doing the usual browsing and then I saw it. I saw it with my own two eyes. They took it away. After I get a wonderful job and everything is going great. After not having to run to the bathroom or be housebound from days to weeks etc. I am not sure what I will do. I'm not sure what any of us will do. But I am sure of one thing. We are all here and we'll get through together.-My thoughts are with all of youShell


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## Bud

There's been a black cloud around our house since Glaxo made their withdrawal announcement. I'm trying to get to the main players in this sad event in hopes that just one will begin to fully understand the impact of this withdrawal decision. I believe that there's always an open door out there and it's just a matter of finding it. As such, I've cut and pasted this entire thread to a word document (43 pages) and sent it to Glaxo and Janet Woodcock (Jeff, I hope that was okay). I'm telling you this not to brag or draw attention to myself, but because everyone of us has to keep trying to get the truth to the players because there is an open door somewhere and perseverance will be the thing that can find it.I hope that everyone of you will continue to keep trying with intelligence to find that open door.


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## JuliaNYC

Thanks Jeff for the new press release (and for all you do for us). Are you going to send the actual survey results to the FDA, and maybe more importantly, to Glaxo? Glaxo felt the compromise offered last week was unworkable, but I think our answers to question 8 show that the patients are willing to do the things that were recommended in the compromise. Maybe by "unworkable" they meant "unprofitable?"


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## Guest

I think we can at least partially blame lawyers for this, (no offense meant to those here that are honerable to the profession) I think Glaxo is terrified of a potential lawsuit. Did any of you see the posting form some lawyer fishing for clients who may have been harmed? Maybe we should contact that bozo and ask if he will instead take on a class action AGAINST the FDA and/ or Glaxo for their removal of Lotronex from the market and the harm that will cause!


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## JJKWright

I hate to rely on Bentyl, Immodium, and Valium for this problem. I worry a whole lot more about taking all of this than I ever did about Lotronex. Lotronex stopped the problem on the front end whereas, all of these just treat the aftermath. I have a job I have to function in and am not sure I'll be able to. Will Ralph Nader see to getting us all on disability paid for by the US goverment?


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## tracey

I have a real problem with the lawyer who posted a note on our website. Do you Mr. Lawyer have IBS? You are like a vulture who has barely seen the bison die before swooping in for the kill. This is why Glaxo is running so scared. I think more testing should be done on Lotronex and perhaps you lawyers should volunteer to be the guinea pigs. Oh wait, that certainly would not represent the general population, just a small subgroup of folks with DNA that is part shark, part rat. Lay off. You are the primary cause for all of this.


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## Guest

Yes, I've seen the posting from the lawyer. That probably is the main reason Glaxo withdrew Lotronex. They're afraid of a class action suit. I thought that lawyer's posting was in pretty bad taste, considering most of us here are mourning the loss of Lotronex.


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## Guest

Any more news on a Glaxo/FDA meeting this week due to the response they received from Lotronex being withdrawn from the market?


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## Anna2

I can't beleive the negativity towards Faith. She had enough courage to tell you her story, and some of the reactions are unbelievable. I can't beleive how harsh & rude people can get. You have to remember that there were quite a few people that had problems with lotronex, and they can't be blaimed for taking it wrong. I am to one of those people that had alot of poblems with it after being on it about 3 weeks. It was a horrible expierence and to think I could have died from it, but then again that would have been my fault! Think about it! That's how a lot of you have treated Faith, and alot of others!


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## Sherree

Well, since the withdrawal of Lotronex a week ago, I decided to quit cold turkey and hoard my 3 weeks supply for "special" occasions. This morning, my 7th day without Lotronex, I found myself in the bathroom 3 times with loose stools, a bit of a sense of urgency, and and an uncomfortable feeling. While not bad diarrhea, I still hadn't felt like that but only a couple of times in the last 6 months. I am taking 1 or 2 immodium pills a day, 2 caltrate a day, and a Bentyl every AM. I felt better later in the day, but I still had to leave the house feeling very uneasy. I am trying not to despair too much, but it's starting to get to me mentally, you know that sense of anxiety, and I don't like it. I was just starting to get over it, feeling pretty good, and doing "normal" things and enjoying it without fearing an attack. I have written to the FDA and Glaxo more than once, I know so many of you have done even more. Let's hope we are heard.


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## Gemgurl

I'm new to the group; driven here by the withdrawal of Lotronex. Lotronex was my "miracle drug." It enabled me to leave the house at will,to shop w/o checking out restrooms, to travel to visit my family,to watch my grandaughter perform in a play. They cured me and now tell me it was all a mistake? I'm angry and I feel betrayed.I can't go back to what life was before Lotronex. I had not one side effect from this medication! I was cured! I was leading a normal life for the first time in 12 years! Does Glaxo have even a glimmer of what they are sentencing us to? I just got off the phone to my daughter in Austin, telling her I can't come to her graduation. She says she "understands." I'm tired of hearing that; I want to participate in life, not just hear about it.I want to register my complaint with both the FDA and Glaxo.If somebody could post phone #'s, e-mail or mailing addresses, I would be grateful.


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## Jeffrey Roberts

http://www.fda.gov/cder/drug/infopage/lotr...sumerletter.htm Letter Regarding Lotronex from Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research The Food and Drug Administration (FDA) has received many letters about Glaxo Wellcomeï¿½s voluntary withdrawal of Lotronex (alosetron hydrochloride) tablets from the market. I would like to thank all who have written to FDA for sharing their thoughts and concerns regarding this action. Most letters have focused on the severity of some cases of irritable bowel syndrome (IBS) and the need for continued access to an effective treatment. I want to assure you that we at FDA are concerned about people suffering from IBS. We have heard from patients and health care professionals and are very aware that IBS can be a debilitating disease that greatly affects quality of life. FDA worked closely with Glaxo Wellcome both before and after Lotronexï¿½s approval on February 9, 2000, to evaluate adverse events reported with the use of the drug, and to develop ways to communicate the risks to health care professionals and patients. These included public discussions with FDAï¿½s Gastrointestinal Drugs Advisory Committee, updating the professional labeling of Lotronex and the development of a Medication Guide for patients. You can find more details about these actions and additional information on the Lotronex Information Web Page. After approval of Lotronex, FDA had to weigh the benefits experienced by many users of the drug against the serious adverse events experienced by others. This risk benefit evaluation was difficult because we were aware that many users of Lotronex did not experience these adverse effects. However, FDAï¿½s view that unrestricted marketing of Lotronex poses a significant risk to patients was based on a review of the severity and types of reported adverse events. As of November 10, 2000, we had received numerous reports of serious adverse events, including 70 cases of: ischemic colitis (intestinal damage resulting from reduced blood flow to the intestine), severely obstructed or ruptured bowel (complications of severe constipation), and death. As we reviewed these reports, we discussed our concerns about patient safety with Glaxo Wellcome on numerous occasions. As a result of these discussions, FDA offered the option of a restricted distribution program to Glaxo Wellcome, as an alternative to marketing withdrawal. A restricted distribution program would have permitted the product to remain on the market under closely monitored conditions. The goals of a such a risk management program include: safer use of Lotronex in appropriately informed patients continued access to Lotronex by severely affected IBS patients under closely monitored conditions continued clinical studies of the benefits and risks, and safe use of Lotronex. After the discussions, Glaxo Wellcome chose to voluntarily withdraw Lotronex from the market. However, FDA is ready to work with Glaxo Wellcome, as with any sponsor, to develop risk management plans to ensure appropriate patient access to medically important, effective drugs. Be assured that FDA is committed to working with pharmaceutical sponsors to facilitate the development and availability of treatment options for patients with IBS. Janet Woodcock, M.D. Director Center for Drug Evaluation and Research


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## JeanG

Thanks for posting this, Jeff. Six of one, half dozen of the other.JeanG


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## Andie

I can't believe that all these people have this problem! After 45 years I got to live the "Life of Riley" for a couple of months! It changed my attitude on just about everything. Then, like a lightning bolt, they took Lotronex away. I really believe we are paying the price for people who weren't very bright in the way they took the medication. Duh..if you are constipated for a week, shouldn't you back off and wait? Now I'm back to being afraid I'll have an "accident" because I've had years of them. Should have bought stock in Pepto-Bismol, Immodium, Lomotil and Tincture of Opium. May everyone in the FDA get it for a week!


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## Jeffrey Roberts

http://www.fda.gov/bbs/topics/ANSWERS/ANS01058.html FDA Talk PaperFDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding withconsistency and accuracy to questions from the public on subjects of current interest. Talk Papers aresubject to change as more information becomes available.T00-65 Print Media: 301-827-6242November 28, 2000 Broadcast Media: 301-827-3434 Consumer Inquiries: 888-INFO-FDA GLAXO WELLCOME DECIDES TO WITHDRAW LOTRONEX FROM THE MARKETGlaxo Wellcome, of Research Triangle Park, NC, has informed FDA that it will voluntarily withdraw Lotronex(alosetron hydrochloride) tablets from the market. Lotronex is a prescription medication approved to treatIrritable Bowel Syndrome(IBS) in women. The FDA is advising patients taking Lotronex to contact theirhealthcare providers to discuss treatment alternatives.The companyï¿½s action follows a meeting held earlier today with the Food and Drug Administration (FDA) wherethe agency discussed with Glaxo Wellcome risk management options that included restricting the distribution ofthe drug or marketing withdrawal.Todayï¿½s action follows FDA analyses of the post-marketing reports of serious adverse events, which included 5reports of death in patients taking Lotronex. Specifically, FDA has been concerned about reported cases of intestinal damage resulting from reduced bloodflow to the intestine (ischemic colitis) and severely obstructed or ruptured bowels (complications of severeconstipation).As of November 10, 2000, FDA had received and reviewed a total of 70 cases of serious post-marketingadverse events, including 49 cases of ischemic colitis and 21 cases of severe constipation. Of the 70 cases, 34resulted in hospitalization without surgery, 10 resulted in surgical procedures, and three resulted in death. FDAhas received two additional reports of death that the agency did not classify as being cases of ischemic colitis orsevere complications of constipation.FDA has been closely monitoring the drug since approval on February 9, 2000. Prior to approval, four cases ofischemic colitis were observed in clinical studies and were discussed at a November 1999 meeting of FDAï¿½sGastrointestinal Drugs Advisory Committee. These cases were transient, mild-to-moderate in nature andreversible upon discontinuation of the drug. Between approval and June 1, 2000, FDA received seven post-marketing reports of serious complications ofconstipation. This resulted in the hospitalization of six patients, three of whom required surgery. During the sametime period, FDA received eight post-marketing reports of ischemic colitis. This resulted in four hospitalizations,four endoscopic procedures, and no surgeries.On June 27, 2000, FDA convened a public advisory committee meeting where risk management options inresponse to the serious adverse event reports were discussed. No deaths were reported up to that date. Theconsensus of the advisory committee members was that both physicians and patients must be informed of thepotentially serious adverse events associated with Lotronex.Following the meeting, FDA updated the healthcare professional labeling for Lotronex and required the drugï¿½ssponsor, Glaxo Wellcome, to distribute a Medication Guide that warned patients directly about the risksassociated with the drug. In addition, at the request of FDA, Glaxo Wellcome issued "Dear HealthcareProfessional" and "Dear Pharmacist" letters to advise these groups of the important new information.FDA continued to receive severe adverse event reports of ischemic colitis and complications of constipationassociated with Lotronex. In addition, FDA received reports of death and more serious complications of ischemiccolitis that required blood transfusion or surgery. Upon completing its recent analyses of the 70 cases, FDA's view of the options included marketing withdrawal ora restricted drug distribution program. The restricted drug distribution program would provide: (1) safe use ofLotronex in appropriately informed patients, (2) continued access to Lotronex by severely debilitated IBS patientsunder closely monitored conditions, and (3) continued clinical research into the benefits, risks, and safe andappropriate use of Lotronex. FDA recognized that the other available treatments for IBS may offer inadequaterelief from a condition that can be severely incapacitating for some patients. At the conclusion of todayï¿½s meeting, Glaxo Wellcome informed FDA that it will voluntarily withdraw Lotronexfrom the market.For more information on this subject, visit the Lotronex Information web page created by FDAï¿½s Center for DrugEvaluation and Research. The URL is www.fda.gov/cder/drug/infopage/lotronex/lotronex.htm.


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## Guest

I was wondering, how long does it take for Lotronex to leave your system. I'd guess it'd vary from person to person, however it's been a week since I took my last pill and I was curious.I'm waiting for the inevitable return to the Way Things Were.I'm also glad that people have posted about the not-so-good side effects Lotronex has had on them. It seemed to work wonderfully for me, but I am very concerned about having side effects and not even knowing you had them. I'm pretty sure I don't have any, I've only had colds since I've been on it, but now I'll double check with my doctor, just in case.


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## Jeffrey Roberts

This letter will be in the January 15, 2001 U.S. News Magazine in the Letters to the Editor: http://www.usnews.com/usnews/issue/010115/15lett.htm


> quote:Letter to the EditorRe: A pill turned bitter by Joseph P. ShapiroMany former Lotronex users have been driven to dispair as a result ofGlaxo Wellcome's decision to withdraw Lotronex. Even with the knowledgeof the "drug's dark side" users maintain that they would gladly take therisk in order to free themselves from the daily grinds of living withIrritable Bowel Syndrome. The withdrawal is a regrettable situation andone which questions why dollars and cents seem to continue to controlthe quality of life for sufferers so dependent on the pharmaceuticalsdevelopment of new drugs.Jeffrey RobertsPresident & FounderIBS Self Help Groupibs###ibsgroup.org http://www.ibsgroup.org


[This message has been edited by Jeffrey Roberts (edited 01-08-2001).]


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## Nath

i think the probem is that people are so desperate for lotonex to work that they ignor e the warning signs and continue to use the drug no matter what. I know if it did not work for me I would be bitterly dissapointed.Take the contipation issue, common sense dictates that if you dont have a bowel movement for a couple of days when usually your in the toilet several times a day, then you should consider dropping you dosage or contacting your docot for advice. However people obviously continue on hoping that everything will sort itself out.I think the desperation that drives us to dispare at the removal of lotronex from the market is the same desperation that drove people to push themselves and the drug beyond their limits.FYI Im male and experienced servere constipation (I corked up after my first tablet) but it was easly managed with fibre supplementation, and within a month i was taking double the dosage (as the recommended did not seem strong enough) and went from 5-10 motions a day before to 1 or 2 with zero pain.


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## Guest

I know that all these posts are the same but here is another. I am so upset! I started taking Lotenex for only 2 days and saw the difference! THen since my mom works for a Dr. called Galaxo to get some stock bottles and found out the news. SO now I have stopped taking it for 5 days and have called in sick one day and have been dieing the rest. I had stopped taking it during that time. WEll I only have a few days left and I am taking the rest so I can at least function! This is so upseting. People should have monitored there doses better not complained about the drug! I really hope this decision is changed!!!!


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## Guest

I just posted under another topic about how Lotronex has helped me. it has been approved in mexico, Argentina, Brazil and South Korea, but not out yet. If anyone is interested I can post email addresses for folks to contact at the FDA and Glaxo Wellcome. I've been visiting another msg board for IBS and everyone there is writing to them, as well as state senators, etc. I think someone even posted the email for Dr. Wolfe (quack). Let me know if you want the info.


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## LotronexLover

Are there any Lawyers that read this bulletin? Can't we (Lotronex Users) have a class action law suit against Glaxo for taking a pill off the market in bad faith? Punitive damages (mental distress)? They had the option to monitor us (compassionate drug distribution) and decided not to because it is not in their best FINANCIAL interest. Glaxo doesn't care about the mental & physical well being of its consumers. They only care about the money & their reputation. They blame everything on the FDA. Playing victim. Yes, it is the FDA's fault too. BUT the FDA gave the go ahead to Glaxo which refused the offer for compassionate drug distribution. The FDA said to Glaxo ..."If you monitor your patients then you could keep Lotronex on the market." Yes, this was confirmed by Glaxo to me to be true. I say we get off our toilets & fight for what we need!!! I wrote to all of the above but I think we should take further action. Hey, maybe I'll write to 20/20 or something next. I think there was another drug that had a similar situation (Prupolcid?) Where the consumers faught the Company & WON! By the way, Lotronex will not be available in ANY country, I already talked to them about it. Again, if anyone knows a legal action that could be taken against Glaxo...let me know. Class action law suit needs 15 people I think? How many Lotronex users that benefitted from the product are out there? 200,000? Like that would scare Glaxo into Compassionate Drug Distribution!


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## Jeffrey Roberts

A class action law suit is not the avenue that we recommend at this stage.The Lotronex Action Group is actively engaged in discussion and letter writing.I suggest you join the Lotronex Action Group and join the campaign. Refer to the link at http://www.ibswatch.com for more information.Jeff


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## Jeffrey Roberts

http://www.med.ucla.edu/ndp/Winter2000Msg.htm The Inside TrakChronic Gastronintestinal Disorders News from the UCLA/CURE Neuroenteric Disease ProgramWinter 2000 - Vol 4 Issue 1A Message from the Director It has been close to one year since our last edition of the Inside Trak Newsletter. Many things of considerable importance have happened during this time, the most important one being the "rise and fall" of the first true irritable bowel syndrome (IBS) medication, Lotronex. Since the issues around this drug are of great importance to many of our patients (and readers of this Newsletter), I want to dedicate this column primarily to the events involving Lotronex. Lotronex, a 5-HT3 antagonist, had been developed by Glaxo Wellcome, Inc. (GW) for the treatment of diarrhea-predominant IBS. Several large scale national and international studies demonstrated an effectiveness of this drug over placebo, comparable to the effectiveness of many other successful drugs, which treat other conditions such as ulcers, migraine headaches, and pain. Initially, it appeared that the only potential side effect of this drug was the development of constipation (seen in about 25% of patients), a complication easily managed by either decreasing the dose, taking additional fiber or in some cases stopping the drug. Later, a very small number of patients on the drug (approximately 1 per 1000 patients) reported increased abdominal pain and rectal bleeding. In these patients, endoscopic examination of the colon showed changes consistent with decreased blood flow to the inner lining of the colon (the mucosa). This complication is referred to as ischemic colitis. Ten patients (out of a total of 300,000 patients) were reported to have developed serious complications with the drug requiring hospitalization, and surgery, and three patients were thought to have died from such complications. While the relationship of Lotronex with the side effect of constipation was clearly established, the relationship with the rectal bleeding (ischemic colitis) was less clear, and a thorough review of the serious complications showed no causal relationship with the drug. However, under pressure from the consumer advocacy group Public Citizen and its spokesperson Dr. Sidney Wolfe, and from a series of articles in the LA Times, the Food and Drug Administration (FDA) requested additional measures from Glaxo Wellcome to minimize the risk of side effects. Ultimately, and sadly, it appears that the FDA sided with Public Citizen in the assessment of the situation as follows: 1) IBS is not a serious disease and does not warrant a drug with any side effects, 2) Lotronex shows only minimal effectiveness and 3) Lotronex is a dangerous drug. We firmly believe that all 3 assumptions are wrong. Many suggestions by Glaxo Wellcome to improve the regulation of the drug were rejected by the FDA, leaving Glaxo Wellcome no choice other than to withdraw the drug from the market. If you are suffering from diarrhea-predominant IBS and particularly if you suffer from the additional complication of fecal incontinence, this is very bad news. The thousands of patients who have contacted Glaxo Wellcome, or unsuccessfully tried to contact the FDA are a testimony to the fact how valuable a drug Lotronex had become. It will be some time before another drug will make it to the market. The criteria established by the FDA in the case of Lotronex (see above) will make it increasingly difficult to get any drug approved any time soon. *It is our firm belief that the decision by the FDA (not to mention the one-sided LA Times coverage and the assessment by Public Citizen) was wrong. Many other options were available to assure maximal protection of patients from rare serious side effects. There are many drugs in common use which have a much higher risk of serious side effects. We believe that Lotronex was a perfectly safe drug, provided it was prescribed by a physician familiar with IBS who took the time to inform patients about the possible side effect of constipation and who was responsive to questions by the patient. Not a single case of a serious complication in connection with Lotronex was observed by physicians at UCLA Medical Center during the 8 months when the drug was available.* We hope there will be other drugs for IBS available within the next two years. These medications include Tegaserod (Zelmac) which also acts on the serotonin system but is different from Lotronex. It is a 5-HT4 agonist which has been found to be effective for the treatment of constipation-predominant IBS and will hopefully be available in 4-6 months. There is another 5-HT3 receptor antagonist (Cilansetron) which is presently undergoing clinical investigation for the treatment of diarrhea-predominant IBS. And finally, there is a substance P (neurotransmitter involved in pain transmission) antagonist for the treatment of IBS which is also undergoing investigation through clinical trials. We will keep you informed about the progress in this development. In the current issue, we deal with several other important topics for our patients: We provide you with additional information about our ongoing non-medical treatment option, the IBS Class. We had intended to start a research study, evaluating the likely additional beneficial effect of the IBS class in IBS patients taking Lotronex. Unfortunately, due to the withdrawal of the drug from the market, we will have to go back to the drawing board and redesign the study protocol without the new medication. We also have produced two articles dealing with the stress response. Rapid scientific developments are beginning to shed light on how stresses in our lives can affect our health and cause disease, including functional GI disorders such as IBS. Finally, we will give you some update on the ongoing research program with another 5-HT3 antagonist, Cilansetron. No serious side effects have been reported with this compound in extensive clinical testing and this drug may in the future take the place of Lotronex in clinical management of diarrhea-predominant IBS.[This message has been edited by Jeffrey Roberts (edited 03-27-2001).]


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