# Death Reports Prompt Another FDA Probe of Bowel Drug (Lotronex)



## JeanG (Oct 20, 1999)

The URL for this article is: http://my.webmd.com/content/article/1728.62866 Death Reports Prompt Another FDA Probe of Bowel Drug By Lauran Neergaard AP Medical Writer Reviewed by Dr. Michael W. Smith Oct. 31, 2000 (Washington) -- Five women reportedly died after using a popular new treatment for irritable bowel syndrome that can cause severe intestinal side effects, Food and Drug Administration records show. FDA officials cautioned that it's too early to know if the drug Lotronex was to blame, or if other illnesses contributed to or caused those deaths. But the agency is investigating Lotronex's safety, even as a consumer advocate renewed calls Monday for the drug to be banned. Lotronex is the first new therapy in decades for irritable bowel syndrome, a mysterious disorder that affects up to 15 percent of Americans, mostly women. IBS involves chronic or recurrent abdominal pain, the sudden and urgent need to go to the bathroom and either frequent diarrhea, constipation, or both. The FDA has repeatedly warned women and their doctors that Lotronex can cause some serious side effects: a potentially life-threatening intestinal inflammation called ischemic colitis, and constipation so severe that some patients have needed surgery to unblock their intestines. Consequently, Lotronex is never supposed to be taken by women who are constipated or have had severe constipation or certain other intestinal disorders in the past. Just last August, the FDA gave the unprecedented order that manufacturer Glaxo Wellcome Inc. attach to every Lotronex bottle a plain-English pamphlet explaining those risks to patients. Then, the FDA cited 33 reports of severe side effects. Now, the FDA has received a total of 49 reports of ischemic colitis among Lotronex users, including three women who died, said Dr. Victor Raczkowski, the FDA's deputy chief of gastrointestinal drugs. It also has received 21 reports of severe constipation, including 2 deaths. The FDA hasn't finished investigating the reports to see if Lotronex is to blame, Raczkowski cautioned. "We're still re-evaluating the risks and benefit of this drug. We are very concerned about these serious adverse events," he said. But Glaxo medical officer Dr. Eric Carter said at least two women weren't still taking Lotronex at the time they died, and a third had suffered ischemic intestinal disease in the past. That means "she should not have received Lotronex," Carter said, stressing how important it is for doctors not to give Lotronex to the wrong patient. Carter said overall Lotronex is a safe and effective drug, noting that side effects have been reported in only a small fraction of the 300,000 people who have taken the drug. But Dr. Sidney Wolfe of the consumer advocacy group Public Citizen again petitioned the FDA Monday to ban Lotronex. "Why continue to endanger the health and lives of tens of thousands of people ... until a 'sufficient' number of hospitalizations and further deaths occur for you to finally take action?" he wrote FDA Commissioner Jane Henney. Glaxo currently is negotiating with the FDA over whether it can launch a major consumer advertising campaign, including TV ads, for Lotronex. A key issue is how the company would explain the side effects.


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## luckylou (Sep 22, 1999)

Thank's for posting this article Jean.


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## Guest (Oct 31, 2000)

Wow... this is scary. Took them years to get Cisapride off the market, I hope they move a little faster with this, if it is, in fact, dangerous.


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## Guest (Oct 31, 2000)

Thanks Jean,Pretty scary







Best RegardsMike


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## JeanG (Oct 20, 1999)

This is the first report I've seen today, and it is pretty scary. It will be interesting to see if the women who died were not strictly D when given the medication.JeanG


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## moldie (Sep 25, 1999)

Oh my gosh Jean, that is an awfully scarey Halloween post. Seriously, it goes to show you that doctors need to obtain better info on their patients, as well as the drugs themselves, before prescribing them. The consumer also needs to investigate the drug and its side-effects and talk it over with their doctor/s before accepting any prescription med.. The doctor and patient communication needs to be better on the follow-up too. It is often not stressed to the patient enough to report specific side-effects promptly, and when they occur, some people go into denial or don't want to bother the doctor about it. I am certainly guilty of not being dilegent enough in the past about searching for the various side-effects so that I could recognize and report them effectively, and intend to play a more active role in the future in my own health. (I'll let someone else go into the drug companies, as well as the responsibility of the FDA approval and testing standards).


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## Mike NoLomotil (Jun 6, 2000)

More news of better life through chemistry.MNL


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## moldie (Sep 25, 1999)

Thanks Jean, I posted my response on the News/Abstracts/Research BB.


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## Mike NoLomotil (Jun 6, 2000)

Fortunately the aggregate mortality rate of directed dietary manipulation, cognitive-behavioral therapy, hypnotherapy and yoga for this "mysterious disorder" is about zero if I am not mistaken.Better life through chemistry.MNL[This message has been edited by Mike NoLomotil (edited 10-31-2000).]


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## partypooper (Mar 22, 2000)

There is a similar repost on the CNN website. Pretty scary and obviously dissapointing for many with IBS-D.However, I am sure that they will be able to develop a better and safer drug in the future.


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## Guest (Nov 1, 2000)

Thank you Jean for the article. Very scary, very scary indeed, and sad.







CB


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## Pokey (Oct 31, 2000)

I hope that they never take Lotronex off the market. Doctor's just need to learn the right people to prescribe it for. I've been taking it for 5 months now and can't imagine life without it. I am pretty much IBS free because of it. I love it and would feel like dying if the FDA took it off the market.


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## Homebound (Jan 27, 2000)

Thanks Jean! That is really scary! I was going to ask my doctor about getting that, but I think I'll hold off and wait. I'd rather be alive and suffering with IBS then be dead after taking that! I hope they find out for sure soon, as it may save lives!Jennifer


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## zigmissus (May 19, 1999)

I read this info earlier today, and was very thankful that the Lotronex samples the dr. gave me are still on top of my dresser unused. I'm MOSTLY D, but am C about 10% of the time, so this drug probably isn't for me.


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## Stace (Sep 20, 2000)

My ob/gyn gave me Lotronex samples for IBS. He told me only to read the insert only if I wanted to "scare myself." I always read EVERYTHING...and it's a good thing I did because I am a C. I have had it with doctors who just throw pills at you and don't even bother asking the necessary questions. It would have only taken him a moment to ask whether I was C or D. Needless to say, he is another doctor I won't see again.Stacey


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## Miss Patience (Oct 23, 1999)

Thanks for your posting, Pokey. I've been on Lotronex since March, and it's given me my life back. I'm practically in tears, thinking about losing it. Then my life will go back to the way it was, which was getting to be unbearable.I asked my dr last week about the risk of Lotronex. She said "it's really very small. If you're constipated, stop taking it". She also told me that for impaction to happen, or a blockage, I'd probably be constipated for a couple of WEEKS, not just a couple of days. One would hope I'd have the brains to seek assistance before then.I'll be frank. I'm disappointed in people on this board who are so quick to deem Lotronex "unsafe" and do that "phew, dodged a bullet" thing. We all know the suffering that IBS causes, and that it's a real problem. To wish that a treatment which has given many people their lives back would be taken away is, well, certainly less than supportive.I don't want to live my old IBS life. I don't like obsessing about bathrooms and wondering if every morsel I put in my mouth is going to be the one that starts the bout of D. I like having my life back. I'm sure further investigation will reveal that many of the folks with bad complications had contraindications. People die from penicillin. People die from Prozac. And it makes me angry that I might lose what I've gained because some people, doctors and patients alike, are too stupid to do what my mom always told me....follow the directions.I'm sure there ARE people who DID follow directions and had problems. But I'm also sure they are far rarer than the folks who shouldn't have had the drug in the first place, or should have stopped taking it sooner than they did.Colleen


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## Mannie (Jan 17, 2000)

I posted a few months back about dangerous side effects reported for Lotronex. The article basically stated that if you are on it, report all possible side effects to your doctor. I don't know if anyone read that post though.


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## Guest (Nov 1, 2000)

If Lotronex is taken off the market, there is already an alternative; Remeron. Remeron works very similarly to Lotronex, by blockade of the 5-HT3 receptor. Remeron has *not* been associated with ischemic colitis, and, unlike Lotronex, works equally well in males. Like Lotronex, Remeron should not be prescribed to patients who are IBS-C.


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## JeanG (Oct 20, 1999)

The article says that the FDA isn't finished yet investigating the reports to see if Lotronex is to blame. Hopefully they'll find out it isn't.JeanG


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## zigmissus (May 19, 1999)

I just had a horrible thought--I hope the women who died weren't members of this BB. Not that it isn't tragic enough, but it would be even more awful if it were someone we knew....As for condemning Lotronex, I don't necessarily hear that in this post. It undoubtedly is a godsend for many, but it sounds as if doctors aren't being very careful about whom they prescribe it to. They just hear "IBS cure" and start passing it out like candy.


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## Nath (Jan 5, 1999)

*news flash*FDA is investigating the link between 5 seperate motor vehicle related deaths of women taking Lotronex...With the amount of people taking lotronex now their are going to be all kinds of things happening to minorities of patents, Im not saying its not serious or should not be looked into, but its a bit early to jump to concusions. I mean that article contained almost no information on how these women died.Should they overreact and ban lotronex? no.Should they make a quick and thorough investigation to determine the safety of the drug? yes.


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## RumbleGirl (Feb 1, 2000)

I became a believer in alternative medicine because of things like this. So many people assume that just because something is prescribed by a doctor - that it's good for you. I am lucky that I have become symptom-free thru diet alone (following a low-carb way of eating) and it saddens me when so many people who are sick - with IBS and other illnesses in general, are afraid to even do something so simple as change their diet or take a supplement. They prefer to wait for a pill because they think it's safer.I'm certainly not suggesting people try every cure they hear about... just that I wish more people would have an open mind that perhaps prescription drugs are not the answer to everything.


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## georgeb (Jun 5, 2000)

Here's a tip,If you don't poop for a couple days, stop taking the medication. And go SEE A DOCTOR! DUH!This is stupid. I take Lotronex, and it ROCKS! I would HATE to go back to the way things were, I'd risk my life to avoid it. If it was taken off the market, I would definately try to aquire it illegally. People die in cars every day, but no one's paying much attention to that.


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## Miss Patience (Oct 23, 1999)

GeorgeB, your post made me laugh. That's it in a nutshell. It would be nice if people would use some common sense and tone down the Chicken Little stuff....Colleen


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## Homebound (Jan 27, 2000)

I have days without taking any medication where I don't go to the bathroom. I suppose I should rush to the nearest ER? To me if I took this and didn't go to the bathroom for a few days it would be rather "normal" for me. And I could see where other people would think the same thing.Hey I'm not saying they should take it off the market. I think it's gonna be a more personal choice of if they trust this stuff or not. And whether you trust your doctor that they are making the right choice by offering it to you. Personally I would rather suffer from IBS then be dead from a medication they are obviously to me playing "guniea pig" with the people. They obviously don't know enough about this drug, and they are just waiting to see how many people die from it before pulling it. I'd rather continue to look for safer methods to help my symptoms then take such a risk. Some people are still swearing by the Phen-Phen drug, even though it's been proven to cause major problems and death. Just because it works doesn't mean it's safe. To me nothing is worth risking my life. There is safer methods in my book. But hey what you do with your body is your own business. What you are calling chicken little to me is just common sense. To each their own I suppose.Jennifer


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## Miss Patience (Oct 23, 1999)

Homebound said: "I have days without taking any medication where I don't go to the bathroom." Then my guess is that Lotronex would probably be contraindicated in your case. You probably shouldn't take it. I strongly believe it will be found that there were contraindications in the cases of many folks with the unfortunate complications. We have people on this very board who are C type whose DOCS gave them Lotronex. That's wrong. And that's why there are package inserts. I always read mine. I believe in your right to decide something is too risky for you. But please don't use your criteria to decide what's too risky for me. Some parents believe vaccinating their kids is too risky. Should everyone's child be denied vaccination? I know someone dear to me who almost DIED from a bad reaction to anti depressants. I don't think they should be taken from the market. There are risks and rewards in all areas of life. A quarter of a million people have taken Lotronex. Perhaps one hundred have had problems. Those are good odds.They always tell you about the plane that crashes....not about the thousands of planes that make it safely every day....Colleen


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## Homebound (Jan 27, 2000)

Where did I ever say you shouldn't take it? Read my first post on this thread, you'll see I said I hope they find out for sure soon, as it might save lives! No where did I say people shouldn't be taking it period.You seem very hostile that some people don't feel this is a safe drug. It's a NEW drug, sure many people are taking it. And some people are dying from it. It's not a drug that's been on the market for ages, and that only a handful of people have died from. It's too new to say it's safe for most people. I think something needs to be done about that. Maybe not banning it right away, but they need to make sure this is a safe drug for the majority of the population to use. Since you know nothing of my IBS I will tell you that I am IBS-D 100% of the time. I do have good days where I don't go at all though. So yes I do fall in the catagory of people that would be offered this drug. So just telling someone that if they don't go for a day or two they need to rush to the ER to make sure they aren't having a major complication of this drug, well that doesn't say much for this drug! Sounds darn right scary to me! Believe me I don't care if you take it. I would never make a choice like that for anyone else. But I think comparing this drug to flying in airplanes is like comparing apples and oranges. Anti-depressants have been around a lot longer then this drug. So again that isn't a very good comparison. As well as vaccinations. I won't give my 2 year old the chicken pox vaccine as I don't feel we know of it's long term results. The others he has had since it's effects are more well known. And the risks are known on the others as well. They don't really know how risky this drug is for sure. Some risks just aren't worth taking in my opinion.I find is selfish that some people would want to continue it being on the market regardless of who it kills. That's sad. Sounds to me like another phen/phen case in the making. But like I said to each their own! If you want to take it and it works for you great!! For ME personally I just won't be a human gunuea pig! I'll stick to my safe calcium thanks! We all have to do what we feel is best for ourselves. So don't worry about what other people think. This is just my personal opinion, and I'm not imposing it on anyone else.


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## Bud (May 16, 2000)

I'm a believer; it's not the lotronex so much as doctor knowledge and common sense. The message is loud and clear .... If you have "C" don't take it and if you've started taking it and have abnormal symptoms, call you doctor for advice and stop taking it if your doctor doesnï¿½t get back to you right away. Sorry, but it seems that simple.We have to all understand that most drugs can have negative side effects. Just listen to the numerous drug commercials on TV. This drug is god send for many and when most negative reports can be attributed to uninformed doctors and poor judgment by the user, it's not time to pull the plug on a drug that's done so much for so many.


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## Miss Patience (Oct 23, 1999)

Homebound, my apologies for misreading your posts. I stand by my comments, but only if they're directed at those who want the drug made unavailable to all of us because of the difficulties of a few people. As for the airplane comment...I wasn't comparing the drug to flying, I was pointing out that the media (of which I am a member) likes to tell us the bad stuff. They aren't going to do a news story that says "A hundred thousand women say they have their lives back, thanks to a new drug", but they sure as heck will jump on the bad reaction stories. And I don't think it's always in the interest of warning people....I DO think media likes to scare people. That's why I just ask for perspective. I would hate for someone in my situation to be too scared to try this drug which may not work, but may truly change her life. Educated decisions, that's all.Colleen


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## Homebound (Jan 27, 2000)

Colleen- I apologize if I came off hostile myself. I guess I was taken back by some of your comments but I see your mainly upset by people who want to ban something that is really working for you. Boy, can I understand that. We suffer so greatly with this, if you find something that helps then it's considered a real life saver to you. Honestly I am afraid to take it. I was even going to ask my doctor about it, but when I read that some people have died I backed off. Now that is only cause it's still a pretty new drug. I used to take birth control pills, and probably will again. And we all know they can cause death in some people. But it's on the rarer side. If that is proven to be the case with this drug I'll probably give it a try. I just wish they would find all this out BEFORE they released it to the people. I mean they take so many years to give it to us, and even then they don't know if it's really safe or not? What's up with that? Anyway I hope there's no hard feelings. I understand where your coming from. And if it is a case of where people just need to be more careful of the way they take it, and the doctors being more careful of who they give it to, then I really hope they keep it on the market for people that it's really helped like you. And I agree the media is a circus, it's hard to believe much of what they say too. Which makes deciding what you should and shouldn't take all that much harder!Jennifer


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