[DeDe]

Hello, I read the article yesterday in the LA Times regarding the possible return of Lotronex. Since it was so detailed some questions came to mind that I did not know. I was only on the drug for 11 weeks, but it was truly a miracle! I had a normal life during this time and I felt great! I cried the day it was withdrawn.While reading it and other recent articles,they stated that people that were on the drug for 3 months or longer develped severe ischemic colitis, needed to be hospitalized, needed surgery etc. The people that experienced constipation for four days was a prelude to ischemic colitis. The clinical trials were only for three months(which does not make sense to me). My understanding is that clinical trials last much longer than that. I remember that I was constipated for the first four days that I was on the drug. I was very uncomfortable but I wanted to give myself an adjustment period.Finally, I had normal bowel habits and from then on I felt wonderful. How long were some people taking the Lotronex, and did they experience any days of constipation? My dream was for Lotronex to come back for all that need it. I am worried that what If I was on the drug for three months or longer that I would have developed the more severe problems? I pray that the drug does come back but I am still worried that after the three months of taking it the above could happen.Thanks!

 

[Debbie Benning]

I took Lotronex for almost 8 months. I was constipated for the first few days also. Took Metamucil and everything went back to normal. From then on for the enitre 8 months I felt great and was never constipated and had the first normal daily BMs I had had in almost 25 years! It was a mircale for me and I cried as well when I heard the news of its withdrawal. The doctor warned me about the constipation and I knew what to do about it. As far as I know, only a few people (out of several hundred thousand prescriptions) bacame ill with ischmic colitis. I understand also that at least some of those that became ill had constipation to begin with which would lead one to believe that the doctor had no understanding of this drug and mis-prescribed it to his patient(s).

 

[LUCIA]

HI. I also read the article.I noticed the Lady that got seriously ill took Lotronex twice per day. That was extremly too much lotronex. I don't think people should take it as prescribed by doctors. Lotronex works the same day. It doesn't need to build up in your system. Most all of us on this board who took Lotronex took according to what worked for us. My doctor had warned me about the constipation problem.So, I would not take the next dose until I had a B.M. That's how it worked for me. I would only take 1/2 tablet. I think Glaxco should do a new study and cut back on the doesage. Maybe 1mg per day? Some of the people who participated in the lotronex study also were not honest about cutting back on the doseage on their own and not telling the Research Co. because they would have been eliminated from the study group. I don't blame them since it was working for them.If lotronex comes back I plan to buy it again. But I plan to take only for emergencies.

 

[LotronexLover]

I was on Lotronex for 1 year & 1 month. I was completely constipated taking 2 pills a day. So I cut the dosage down to 1/2 pill daily (1 whole pill when stressed). They state on the label "As soon as you start to experience any constipation stop taking the medicine & contact your doctor." As soon as I got contipated that's what I did. I think in most of the surgery cases they got constipated & kept taking it...causing complete blockage. My doctor said when taken properly it is completely safe. I never had any other problems with constipation after reducing the dosage.

 

[taffy]

I was on the lotronex for about 9 months. I did not have any problems. I have very severe "D" and lived every day on Imodium. I had a very concerned DR and I think that many were taking it with out having the watch eye of a concerned DR. you would be suprised how many Drs give a patient something just because they want it or demand it. That is why we are having problems with antibiotics. They have been perscrible when it was not neccessary but the patient demanded it. Now we have antibotics that are no good because they have been over used and the germ is resistant to the antibiotics. And also there were people taking Lotronex that were not "D" only. The drug was designed for "D" ONLY. Not alternate "D" and "C". I feel there in lies some of the problem. My warning letter on Lotronex said that if you become constipated for more then one day don't take the med till you have a normal BN.I started out with 2 a day and with in 2 weeks I was able to take a lengthy trip by plane. No way would I of gotten on the airplaine if I had not of had the lotronex. I had a wonderful time with my Grandchildren that I had not seen for 5 years. I ate out and I had not been able to do that for a good 6 years. My DR had been informed of the possible dangers of the drug and even though I was having no problem he ordered a colonoscopy. I came theough with flying colors. The drug was pulled off the day I had my colonoscopy. By that time I had been only taking 1 tab a day. I felt as good on 1 as when I was taking 2. There were days of slight constipation but was very aware of my systyem and did something about it right away. I think that anybody that lets them self go 4 days with no bowel movement was not in tune with their system and or very foolish. I used Metamucil fiber wafers or eat something that I knew would break it loose(Usually chocolate or some peanuts).I think that it is very important also to keep a record of your BM,s. I didn't trust my memory as to how many days I had been with out a BM. I also kept a record as best as I could of what I ate. I'm very excited about the possibly about it coming back. I talked to my Dr and he said he would relate to the company that I was one who did not have problems with the med. He said it will be released possibly on a very restricted basis and possibly not even become aviable to the general public with out a Dr's statement to the company. I understand that it will be possibly only released first to thoes that were on it before and had no problems. I have some pills left that I was saving in case I was to take a trip but I have permission from my Dr to go ahead taking one a day if I wanted to. I hope that I have enough to hold me till it comes back.Taffy[This message has been edited by taffy (edited 05-31-2001).]

 

[Guest]

There were many trials. Not just three month trials. There was at least one trial that was at least 12 months long. You can't believe the media's account of the Lotronex ordeal. The issue is much more complex and balanced then many of the one sided media accounts. Many of these articles are not fair and balanced accounts of the facts. Some of these articles clearly have an agenda...additionally many of these articles are poorly researched. One of the problems is that the media is relying on many "non-experts" as sources for their material. They are not doing their homework and getting to the heart of the real issue...an issue that, if I wasn't personally invested in, is a pretty intriguing and closely balanced (ie risk vs. benefit) issue.I'm not sure if the main problem with some of these articles is that the writer's are unintentionally sloppy and are generally incompetent...or that they are hyping the situation in order to magnify the controversy and make the story more dramatic and compelling. In either case there is some pretty poor examples of "journalism" out there. An internal UCLA medical center newsletter (intended audience the medical center's doctors) indicated that the LA Times initial article was both one-sided and biased. The LA Times author avoided contacting the people in the "know" ie practicing GI's...and instead focused on quoting "political" players. The success of a drug is ultimately determined by both healthcare providers and patients. The "political" players, and I'm referring to the FDA, consumer "advocacy" groups, the drug companies, the media form their opinions by standing on the sidelines watching the action through binoculars. If you want the real story ask the people getting bruised and dirty on the playing field....not the commentators sitting up safe in the play by play booth.

 

[Ugh]

I found this board after the whole Lotronex thing. I am wondering about a few things.First, what was the method by which this drug worked? Also, my GI mentioned that when it was available he refused to give it to his patients. Were there some warning signs early on? What were the side effects? Was colitis caused by simply being constipated, or some other mechanism?Lots of questions, so if anyone can answer them or point me to a link that has info on it I'd appreciate it.[This message has been edited by Ugh (edited 06-01-2001).]

 

[Kathleen M.]

It interacts with a specific serotonin receptor that is in the gut and effects the motility of the gut.There was a 1 in 700 or so incidence of ischemic colitis in the clinical trials. Constipation doesn't seem to be a warning sign of ischemic colitis (note alot of drugs have been associated with this side effect including illegal drugs like cocain and OTC like ibuprophen). One of the concerns is that there isn't a good profile for who gets IC and who doesn't. It gets more common as you get older and why anyone gets it from whatever cause isn't well established. If there was a clear cut warning symptom in place it would help in getting it re-released, but so far it's kind of a mixed bag. IC is when the blood flow to part of the colon stops. Most of the time it is reversable if you stop taking whatever drug your taking when the bleeding starts, and get thee to a medical facility for care. Sometimes surgury is needed to remove the damaged portion of the colon, but that is in a small % of the people who get IC. A very small percentage of people can die from IC.Some doctors don't like to prescribe anything that is new because sometimes there are problems that aren't seen in the trials, but are seen once tens of thousands or millions of people take them. Kinda like don't buy a car in the first year of production kinda thing...K.------------------I have no financial, academic, or any other stake in any commercial product mentioned by me.My story and what worked for me in greatly easing my IBS: http://www.ibsgroup.org/ubb/Forum17/HTML/000015.html [This message has been edited by kmottus (edited 06-01-2001).]

 

[Ugh]

Kmottus, thanks so much for the info. I guess I was wondering about the Lotronex because my doctor seemed pro Zelnorm (although this was a month ago) but also had refused to give people Lotronex. Like he had heard bad things about it before it's release.you said: "It interacts with a specific serotonin receptor that is in the gut and effects the motility of the gut."Is this the same method as Zelnorm?

 

[Kathleen M.]

Yep,But different serotonin receptor.Different ones have different roles. SSRI antidepressants act on a different serotonin receptor.Most of the neurotransmitters are used for alot of different roles and its what receptor is being triggered by the neurotransmitter and which particular nerves are stimulated that causes the different effects.And alot of them are not limited to nerves.Histamine in your brain is involved with alertness.In the tummy it is involved in signalling the release of acid,And in your nose, lungs, skin, it's used by the immune system to trigger an allergic response.K.------------------I have no financial, academic, or any other stake in any commercial product mentioned by me.My story and what worked for me in greatly easing my IBS: http://www.ibsgroup.org/ubb/Forum17/HTML/000015.html

 

[Oksana]

I was on Lotronex for 7+ months and it was a godsend to me. My GI gave it to me, and only casually mentioned constipation. I went from 6+ loose movements a day to 2 firm ones and all my cramping/urgency disappeared within 2-3 weeks. My energy level tripled. I have a genetic muscular disease and I was feeling stronger and even walking more steady! I was constipated 1 DAY. So, I ate a salad and a large peach, and no more constipation. I had mild constipation a few other days on it, but I only 1 day where I did not go at all. I never lessened my dosage. Lotronex enabled me to meet friends in restaurants and actually eat, instead of having a cup of tea and watching them eat (for fear of an accident). Lotronex enabled me to eat salad (I love romaine) with raw veggies and actually DIGEST the salad, instead of finding it in the toilet the next morning! Lotronex gave me a summer of eating peaches everyday w/o have D the next day! It was wonderful! I cried for days when I was unable to renew my Rx. So, I weaned myself down to 1 pill per day and was fine for a month. Within 2-4 weeks of stopping, ALL my symptoms returned. Now, I go 4-6 times every morning, I have terrible urgency and I am paranoid about finding bathrooms when out in public. It is HELL all over again.I KNOW that MDs wrongly Rxed Lotronex because I have a galpal who has Spinabifida and a paralyzed bladder/colon. Sometimes she is constipated for 14 days and must go to the doctor for relief! Her GI gave her Lotronex! When she told me, I begged her not to take it, as I feared she'd get an impaction and rupture. She listened to me. My doctors told me I probably saved her life. She got a new GI and I got her Lotronex! My MD is a D.O. and board certified in gerontology and family practice and he said, "People over 65 spontaneously get ischemic colon all the time. A few of the Lotronex deaths were elderly people who shouldn't have been on it in the first place. A million doses were taken and 6 deaths is nothing. I think when they research the other complications they'll find that people were taking it that should never have been prescribed it in the first place." If they reintroduce it, I WILL take it. But, I will probably take 1 pill per day. The package insert said it was most effective on an empty stomach. That's how I took it, first thing in the morning. I found if I took it after a meal, it was not as effective. There are 5 kinds of seratonin in the body, one controls GI motility, Lotronex suppressed the production of that kind of seratonin. It did not cross the blood/brain barrier, and therefore, did not mess with your emotional state. I believe that people with IBS w/ D have too much of that type of seratonin. I also suffer from too much acid production and take Prevacid 30 mg. 1x per day.

 

[knothappy]

I agree with those who said when you get constipated--quit taking the pill until you have a bowel movement. It is common sense. My GI said you have got to take 2 a day each day--i reduced the amount myself down to 1/2 pill a day and I was in heaven. i could pretty much be a normal human being, now it is back to IBS hell. I think those who got sick listened to their Dr. and probably took 2 pills each day even they did not have a bowel movement for 2 weeks!! There are some people who will jump in a lake if their Dr. says so.I still have some rationed Lotronex and I save it for special occasions . Another thing that I think was wrong on this pill was that it had to build up in your system--It works the same day for me as some one else stated in another post. Well lets just hope and pray they bring it back!!!

 

[Guest]

dede and others, there is a lotornex forum and the LAG could use your insights I would think.tom

 

[Jennifer7]

I was in one of the 12 month trials. Un-fortunately I was on the placebo. I havebeen on it for 8 months and it has beenwonderful! I hope they put it back on themarket before I run out in August!

 

[KimNicole]

It doesn't make much sense how people with "C" would take the exact same medication for people with "D". I know I would have said something. And again, this isn't the first drug with side effects (fatal ones) that still made it on the market. More research, better screening before dispensing... come on now. It helped so many of us. Peole with this sickness for so many years. I am 32, and have had this (IBS D) since I was 8. The second time in my life where I had regular BM for more than twice a year. The only other was when I was pregnant.