Zelnorm withdrawn

I have to say that I am not sure your information on Zelnorm is accurate. I am taking it and have been for a while now. Just stopping during my pregnancy. It was re-prescribed to me after I had my baby. Where did you get this info.

Lacy, the info is accurate - if you follow the links to Novartis or the FDA which I gave, they have both issued statements on the withdrawal of Zelnorm in the US. It has also been withdrawn in Canada now.

You may well have pills at home which you have already been prescribed, but the drug was withdrawn on 30 March and so no further prescriptions will be given after that time.

What are we to use? I do not want to use Exlax or any strong laxitive.
The Zelmac is the only thing I ever tried that works Every time! Just because a few had problems with it take it away from everyone!!
I hope they come up with something quick! I only have a few pills left that I am spliting in half!

For Chronic constipation, you may want to ask your doctor if Amitiza is right for you.

I never knew how debilitating IBS was until I started assisting Researchers trying to help those that suffer with IBS . I have their contact information for anyone that would consider being part of their research projects.

Liz - are these researchers based in the UK or US?

P.S. I live in the UK, where Zelnorm was never available, and anyway, I doubt it would help with my kind of IBS, which seems to defy categorization, but I do think that it's shocking that they've withdrawn it. It's terrible to think of people having to ration their last few pills, by splitting them in half, etc. When you've found something that actually works for you (for me that day has not yet come), it must be awful to have it suddenly snatched away from you.

I do understand that the medical establishment has to carefully balance the benefits of any medication against any possible risks or side effects, but in this case, like Sophie says, I think that this process may have been skewed by the fact that many doctors still do not appreciate quite how debilitating IBS can be. It's just not regarded as a serious illness, because it's not life-threatening, but, in terms of how it affects people's quality of life, its effects can be devastating.

My struggle with IBS, which came on mysteriously and suddenly a few years ago, has left me clinically depressed (I am on medication for this, which is helping a lot, thankfully. With the depression, NOT the IBS, I must stress - well, I know that you guys wouldn't for one moment suggest that the IBS was just a symptom of the depression, but, as you can imagine, this marvellously insightful theory has been suggested to me by plenty of well-meaning friends, relatives and acquaintances, even though it makes absolutely no sense, since the IBS preceded the depression by nearly a year, and it was only after trying one approach after another to no avail (at first I had the naive idea that I could be cured) that I finally succumbed to depression, which obviously hasn't really helped me to cope with the day-to-day struggles of living with IBS.

I often vaguely toy with the idea of suicide as the only failsafe IBS cure (don't worry - I wouldn't really do it), but if I (or somebody else) with IBS were to kill themselves (I'm not being over-dramatic - it's not completely outside the bounds of possibility, though I do admit that I have never heard of any such cases myself), then it would be the IBS that (in an indirect way, I admit, because it triggered off the depression that then caused the suicide) had contributed to their death.

And even if people don't quite go as far as killing themselves, that doesn't in any way negate their suffering (people with IBS do tend to suffer higher rates of depression than the rest of the population, as various medical studies have shown). So, when you look at it that way, you can see that maybe the medical establishment should have thought more carefully before withdrawing Zelnorm.

Well, I think I will stop now, but it felt good to have a rant! Thanks for listening, everyone. And thanks again, Sophie for your brilliant blog. You are a star.

I was on zelnorm for almost two years. I am now using Amitiza and it is horrible for me. I am bloated, with headache and eye twitching and have only been able to be on a liquid diet. I still can't use the bathroom. I am so hungry. My acid reflux is also back. I don't know what to do. I am facing a IPN unit on Tuesday.

I have had IBs probably 15 years. Often been told it was in my head or eat more vegetables. I took every concoction and fiber supplement that I could find. To no avail. Finally found a Doctor one month ago who prescribed Zelnorm. I felt better after two days. Now I Don't know what I am going to do...because I took the last one today. I already am stressed because I know what is coming.

How do we start the fight to get Zelnorm back on the market? I'm devastated. I was prescribed Zelnorm in January '07 after battling IBS for over 30 yrs. I got quality of life back. I still have about a month's worth left and will not stop taking it. This is inhumane. And the 13 people who experienced cardiac were men who are NOT supposed to be taking Zelnorm. This smells of something political to me.

My sympathies go out to everyone who is suffering because of the Zelnorm withdrawal. I'll compile some details about who to contact to try to get the drug back on the market - the main contacts would be the manufacturers Novartis and the FDA, I'll put their details in a new blog entry soon and on the Zelnorm page of my IBS Treatment site.

Just to say, Zelnorm was originally only approved for women with IBS, but it was then additionally approved for men and women with chronic idiopathic constipation.

How do I find your IBS treatment site?

Thanks.

Hi Susan - the IBS Treatment site is at www.irritable-bowel-syndrome.ws

FYI:

Zelmac (Zelnorm) is still approved for sale in Mexico. Now all I have to do is find out how to get it.

Susan

You can get Zelmac (Zelnorm) from medsmex.com. I am thrilled.

Here is an example of when the benefits outweigh the risks - how do you explain to a 90+ lady with dementia who doesn't really understand what IBS is - why she cannot have the one pill every other day that has kept her for the last 2 years of her life from being in fear of the constipation she has known for most of her life.
At least allow the person with the problem to make the decision - there is nothing else available!! At 13 to 11,000 odds - why can't we have the chance of having a "normal" life - free from the horrors of severe constipation - frequent enema's and several trips to emegency!!

I was glad i wasnt the only one wanting ZELNORM back, i to have been taking it for months after years of no hope and also suffered through depression cause of the bloating,acid reflex,fullness and so on.I love and miss it so,but recently before the recall i had been having chest pains and just shruged it off as stress but now i wonder? But anyway regardless if is connected to Zelnorm or not I am screwed again without it,i already started bloating,burping and crying cause one minute my clothes fit next i got to unzip.I wish they use me as a gunea pig for their new study ,i hope it comes back! In the meantime i surf the web for new hope.Thanks for letting me unload to someone who understands.

My order for Zelnorm (Zelmac in Mexico) has been shipped. They notified me by e-mail. I'll let the board know when it arrives.

I received my Zelnorm (Zelmac) from Mexico. It took about 2 wks. However, the cost is $80 including shipping for only 30 tablets. I don't think I can afford this. My doctor has written a prescription for Amitiza. Think I'll try that next.

My daughter is 8 and has been on zelnorm for almost 3 years now. It has done wonders for her but, now we are back to the old way of life, with her being doubled over every several days hurting because she can't go and now her doc says that she is going to probably end up going back into the hospital approx every 6 mos to have her stomach/bowels cleaned out.

How do you explain to an active 8 year old who does not eat much sugar, drink milk or any of the other things children do, since we have had to change her diet. That now that's just the way life is because some people who should have not even be prescribed Zelnorm had complications.

And now you see all these lawyers on the internet coming up with lawsuits, what a bunch of crap!!! I have thought about getting her medicine from mexico but it gets very pricey.

I have been on Zelnorm for 3 years now! My quality of life is fantastic! It is breaking my heart to hear that it has been taken off the market. I just called to get the prescription filled and they told me it was a no go. Too bad I didn't know how soon it was pulled off the shelves of I would have stocked up. I think that today or tomorrow is my last dose of it. What am I supposed to do? My body rejects food if I don't take this wonderful medication that we all know and love - ZELNORM!!!!!
Regarding Concerned Mom's comment, I know that it is going to be rough. I have had IBS since I was a baby. What a crappy thing to have to deal with, let alone as a child. You just need to help her find others with it and she will at least mentally feel a little better. I had no friends as a child that I could relate with illness-wise. Now, as a 26 year old, I have quite a few friends that IBS is how we found each other. She will feel out of place and unusual. All you can do is love her and be compassionate. I wish that I had more helpful advice but I don't. Sorry.
I also believe that this who taking-it-off-the-market is ridiculous! What on earth are those of us with no quality of life before Zelnorm, to do? Praying for all of you IBS friends!

Zelnorm is the only medicine I can take and live a almost normal life.I was in the hospital when the doctors put me on it a year ago.Life began for me after two days.Now I look like I'm going to have triples any day and I'm 60 years old.I really need zelnorm to live a life without pain.I have been to three doctors and they all say how sorry they are but there is nothing they can do.My body also rejects food after awhile and then I will end up in the hospital again and everything starts all over again.Not a good life!!

I searched online for fda.gov + zelnorm, went to a linked site and here it is: Question #11:

"11.  Will there be any way for patients to receive Zelnorm?

FDA will work with Novartis to open a treatment protocol (treatment IND) to allow access to Zelnorm for patients with no other treatment options where the benefits may outweigh the risks. 

In addition, FDA has indicated to Novartis a willingness to consider limited re-introduction of Zelnorm at a later date if a population of patients can be identified in which the benefits of the drug outweigh the risks.  Any such request for reintroduction would be discussed at a public advisory committee meeting before an FDA decision."

I called Novartis and was told our doctor must call 888-669-6682 and ask for a Medical Information Associate.

In addition to IBS I have scarring/adhesions on my bowels from surgery for ruptured appendix and have almost no peristalsis. I believe my case is an example of "benefit outweighs the risk." I have an appointment with my GI at 3:00 today and will bring this information along with my terrible constipation (even with Amitiza).

Would love to hear from someone who has adhesions - especially if fiber is good or bad for us?

Can someone help me in ordering Zelmac in Mexico??? I did go a month ago & get a month supply but it is very hard for me to make the trip....Thank you for your information...

See Michelle's comment above.

Michelle - I totally identified with what you said. Part of the misery of having IBS is the feeling of being the only one, and of having nobody to relate to, and my heart breaks when I think about Concerned Mom and her little girl, because when you're a child it's so difficult to deal with when there's something that makes you different from all the other children.

Sometimes I think (I do a lot of musing about IBS!) that if everybody in the world had IBS, and that was just the way the human body dealt with the whole digestion process, then it'd be easy to accept. It would just be how things were, and not taboo at all. Everybody would spend ages in the bathroom, have to watch what and when they ate, be in pain for a lot of the time, etc. And it would just be part of the general human condition.

If that were the case, I don't think having IBS would bother me at all - it would just be one of the many trials and limitations that come with being a human being, e.g. not being able to breathe under water, having to spend a good proportion of one's life asleep and the painful separation from loved ones when they die.

This may sound absurd, but imagine that everybody (except a small minority of people) didn't need to sleep at all. The people who did need to sleep would be at a terrible disadvantage - their lives would be limited and so would the activities they could engage in. There may be lots of jobs that they would be unable to do.

Some people would tell them that they didn't really need to sleep ('It's mind over matter. Just stay awake and you'll be fine!'). The people who needed to sleep would feel a little bit stigmatized (they might even be the butt of jokes) and sometimes some of them would force themselves to stay awake, just to be like other people, until they collapsed and realized that they would have to give in to their bodies' limitations to avoid even greater suffering.

But since, in the real world, everybody needs to sleep, nobody bats an eyelid, and nobody feels disadvantaged by not being able to stay awake all the time. So if everybody had IBS, that would be just how it was, and we'd all just accept it, not knowing that things could be any different.

Probably for me the most awful thing about IBS is seeing all the people around me going about their daily lives without having to worry about (or even be aware of) their guts, and feeling horribly disadvantaged in comparison. I guess that's why I am so glad that I live in a time when it's possible to connect to people over the internet. Since I found this cool website I have certainly felt comforted and less alone, and, like Michelle says, it's really nice to have people to relate to illness-wise.

Well, I hope at least someone out there didn't get lost reading my philosophical musings, and kind of identified with what I was saying. Reading over this post, I see that it is a little bit far out and bizarre!

I have read all the stories of people with IBS and I feel some may have Gastroparesis which has been misdiagnosed. I have gastroparesis which means paralysis of the stomach, intestines, and in my case the colon also.

I have one "big dead gut" the Doctor said, who specializes in this rather rare disease. Actually about 1 million people have it worldwide, about 1/3 being diabetics, but the other percentage from head trauma-concussion/brain stem/spine trauma like mine and also many have it for unknown reasons.

I am on a liguid diet, soy protein powder called Natures Plus, Spirutein soy powder, which I buy at Wild Oats or Health food stores. It tastes very good if mixed in a blender with water, a little apple juice & cran-respberry if you buy the Strawberry, Raspberry Royale & Nutty berry flavors.

Zelnorm helped me due to the BM help and the fact that it has a side effect that makes the stomach empty into the intestine and gives the intestines needed parastalysis which I do not have (contraction that moves food/nutrients along the GI tract).

Now I have to take Erthyromyacin (an sntibotic that has a side effect of giving you diahrea, but for me it only helps a little to give a BM due to my intestinal parastalysis. If this is your problem try it in 350 mg doses about 45 min before eating and it also helps the stomach to empty which is the main reason I take it.

But I used to take Propulsid and the FDA took that away & my symptoms have gotten much worse this past 2 years, in which I cannot eat even the limited things I could eat like whole wheat toast/english muffins or wheat/flax cereal with soy milk and some cookies and desserts which are easily digested.

I have constant vomiting, resulting in constant starvation and dehyration, and I am basically dying, too weak to do anything. I weigh 80 lbs. and I am 5'6". I also have complex medical problems from an accident which makes live painful due to the resulting chest pain from THO Syndrome (compressed artery causing neuropathy pain in my chest & left side)which in itself is debilitating, and pain from other neuro problems, & Fibromyalgia/Fatique due to the trauma on my body.

I feel sure that many patients that have IBS have Gastrparesis. If you feel bloated, nauseated, after eating, you probably have it. It varies from minor to severe cases. I am severe case. Look it up on the internet.

I am trying to make Gastroparesis known by the public so more research is done on it. It is much worse than cancer cause you suffer for eyars as in my case 42 years of vomiting and starvation and having only a little quality of life and then after my ascident I had absolutely no guality of life. It is a debilitating disease that interferes with everything you do & and sice socializing revlves around food, you cannot socialize, go out to eat or anythig and everyone wants to know why you are so skinny and are rude enough to ask.

I am weary of trying to explain and it also jurts very much that a lot of people think I have Anorexia, which is an emotinal problem where people refuse to eat to have some control over their lives, which hs nothing to do with a GI system that does not work!!

It is very frustrating that the medical community has ignored this disease except for a few Dr.'s that do research, but not much progress has been made and NO MEDS have ever come out strictly for Gastroparesis, we only get those drugs that have side effects of causing diahrea or gastric emptying, and Zelnorm helped and I could have a BM a lot of the time, the rest of the time I have to take a laxative.

If you need a good laxative that does not cramp you try Glycolax or Miralax. It is easy to take and clear in water. It helps and will really help for those who only have constipation. I hope you will bring this disease to your Dr.'s attention even though there is no remedy you will know if you have it. THeir is a device that can be implanted in the stomaach put out by medtronic, but only works for those who have some parastalysis.

I hope this info. helps some of you. I am a wealth f knowledge on this disease as I have been used on experimential drugs before they came out and of course none have worked. THe Propulsid helped, but was taken away by the FDA due to heart attack/stroke etc. like Zelnorm.

I've been taking Amitiza now that Zelnorm was pulled. I take it with breakfast and dinner and don't know why my doctor didn't tell me about this sooner. With zelnorm . . . sometimes it worked, sometimes it didn't, but Amitiza has worked the whole time so far.

I am looking to buy Zelnorm for Gastro paresis. I am hoping I can buy it over seas somewhere. I can't take Reglyn or erthyromyacin. I am incapacitated with stomach pain and nausea without it. Does anyone know a site to buy it from? My heart goes out to all of you and I will pray for you. Never give up and lose hope. There are miracles happening everyday. I believe that God is in this struggle with us. Also, Zelnorm made money for this company and money talks in our country. I believe some company will come up with an alternative soon or Zelnorm will be approved for limited use.

What countries are still selling Zelnorm/Zelmac besides Mexico?

At the moment I have only heard from people who have bought Zelnorm in Mexico, either through medsmex.com or in person. Although Zelnorm has been withdrawn in the US, Canada and Australia, and has never been available in the UK, I believe it is still available in some European countries, but I'm afraid I don't have a list of these (it was approved in more than 50 countries originally I believe).

I got my Zelmac from medsmex.com. Granted, it ends up being 4xs the cost I used to pay w. my insurance. But it works!

The only thing is, I was so afraid I'd get arrested at the post office when I went to pick it up!

My doc gave me Amitiza and I took it for about 5 days and had to quit because the nausea, dizziness, and bloating were AWFUL, even though I did have a light meal when I took it.

I asked my GI doc about an SSRI antidepressant to try (cymbalta or effexor - so as to avoid weight gain like w. prozac) He is considering this and will let me know if he wants me to try it. But then again, it might have bad side-effects, too.

I really hope the FDA re-approves Zelnorm for women or people with no CV risks or whatever. It totally changed my life. Now I'm back to the pain and straining I have had for 25 years.

My doctor also gave me an alternative with Amitiza just about 4 days ago never took it before, and I tell you I feel AWFUL with the nausea, dizziness and also blotting, not the same effect as Zelnorm at all. Amitiza to me personally is no more than another exlac with some other ingredients but it really doesn't control IBS.

I am taking Nexium to control the heartburn produced by the effects of my IBS and helped me tremendously... I also have the ability to contact an IG Doctor in Mexico so that he can get me the Zelmac he can get as mach as I need and the prize is almost the same as if I am paying here in the U.S. for Zelnorm with my Insurance I think this is a good way to go for the people that is trying to find a way out and get the quality life back once again like my self. But still I feel a little nervous about the side effects that the press or FDA is stating like heart problems etc. although I never felt any of these effects.

Does anybody know the statistics/ratio of patients that had this heart failures against the once that didn't had any of this problems.
Thanks

It was 13 out of 11,614 patients (or 0.11%) who experienced heart problems, and all had pre-existing heart conditions.

Zelnorm is not approved in the European Union and never has been. It was available under its other name, Zelmac, in Switzerland until May 31, 2007 when the Swiss equivalent of the FDA asked Novartis to pull it from the market. So it looks like Mexico might be our only option. I have read that it was originally approved in several Latin American countries, South American countries, the Phillipines and South Africa, but I can't find any detailed information about which countries or information about whether or not it is still available there.

Before I ran out of my last "legal" prescription of Zelnorm I tried Amitiza with disatrous results. It made me violently ill. So I'm now taking the Zelmac that I got from medsmex.com and life is beautiful again. It's worth the price and risk.

It is nice to know I am in such good company. I have never posted a comment on any web-site, ever. I had been taking Zelnorm for about three years...my miracle. When they pulled it off the market, I like many of you panicked. I gave it a go with nothing for a month, and ended up talking with my doctor about an alternative. He prescribed Amitiza, which was horrible. I took it for 6 days, 6 days with no relief, and nausea that was so overwhelming I could barely make it through the day. Now I am trying Miralax which is Ok at best. Things are moving, but my stomach looks like I am about 5 months pregnant...my pants are all to tight, and I find comfort only in getting home and putting on my pajama pants with the elastic wasteband!!! Bring ZELNORM BACK!!!

I too have been desperate since Zelnorm was taken off of the market. I am so desperate that I just ordered two months worth of Zelmac from medsmex.com. It is very pricey since through my insurace I only paid $10 for a three month supply of Zelnorm, but I just can't take it any more.

Susan, I ordered on blind faith after reading your post. My only disappointment was reading that it took two weeks to arrive. We have to do something to get Zelnorm available again in the US. I will continue to monitor this site, and if anybody finds out something we patients can do that would actually help expedite that, I will gladly join in.

People who have never suffered this way have no idea. I am a very fit and athletic woman in my late forties. Outside of this I am in great health. Why can't we just pass a physical or something? Why can't they just disallow it for men with heart conditions??

Barbie, I read your comment and decided to share my experience with you. I FOUND A SOLUTION THAT WORKS BETTER THAN ZELNORM FOR ME.

I have suffered with IBS since I was about 21. I'm 38 now and I am in the best shape of my life. I exercise daily for about an hour (weights, cardio, yoga - something different everyday). I eat real good icluding vegetables, bran muffins and other wholesome foods. Previously all this healthy living did not help my IBS. I had every test known to man and I checked out fine. I have tryed everything and nothing worked. Then I discovered Zelnorm and for the first time in many years I felt equalized. Then you-know-what happened. I was really bummed out about the ban. I read the others comments above and decided to go see my doctor before I ran out of Zelnorm (yes I'm a guy that was on Zelnorm - some of us need it too). I thought I would try Amitiza but my Dr would not give it to me. He gave me Lactulose Solution instead - a perscription liquid - I take 1 tbsp nightly before bed. It is not like a stimulant laxative. I feel very normal and regular. Then I eat 1/2 papaya in the morning along with a light breakfast. I also take one tablespoon of flaxseed oil (available at Tarder Joes). This combination works better than Zelnorm ever did and without the occasional gassy bloated side effects. For the first time since I was 21 I am as normal and regular as ever. I mean really good! I also feel better about not popping a pill. The Lactulose Solution is a pretty harmless liquid that just kind of passes right through you. I hope someone else can benefit from this as I have.

I received my second shipment of Zelnorm (Zelmac in Mexico) from medsmex last week. This time it took less than two weeks to receive. I ordered two months worth this time. When I went to see my doctor last week he was shocked that it was available in Mexico without a prescription. I told him Amitiza was a disaster for me and he agreed this was a good option for me considering the current circumstances of this drug in the US.

I'm just looking at this site for the first time today, and like the rest of you, I'm devastated over the loss of the one thing that worked for me after about 30 years of IBS. I used Zelnorm for three years, and it was a wonderful break from the misery. I'm really interested in joining the fight to get Zelnorm back. I just need to know the most effective way to accomplish that.

Thank God!!! Ordered Zelnorm from mexico online. Took two weeks to receive, but its here! Amitiza made me want to puke, and it would swell my legs up! Zelnorm is the only thing that works for me!

I had used propulsid years ago, and it worked wonders. After that was removed from the market, my symptoms were horrible again. I tried zelnorm, but that didn't work for me. What I use now is miralax, which used to be prescription but now is available over the counter. I take it every evening with 8 oz of liquid and it works great with no cramps or any other side effects for me. My doctor also said that it is safe to take long term, because it doesn't use stimulants to work.

i am terribly missing my zelnorm, has anyone heard if it may come back, my doc is trying (or they say they are} to get it for me on a compassoniate care basis as i have pancreatic cancer, and i have alot of stomach issues and zelnorm helped alot. i'm going to southern california soon and i wonder if i go over the border to tj if i could find it? any thoughts?
thanks for any help in advance
kathy

i went over the border and walaa, i got zelnorm with no hassle at all. $40.00 bucks for 30. thank god it works!! anyway if you live in california it was a breeze to go to tj. or even if you know someone who is going to mexico for a vaca. just thought i would let ppl know.
k

can anyone please tell me how to order zelnorm from mexico?It was the only thing that has ever helped me.

Karyln - the only site people have been talking about is medsmex.com, but I would be very wary as you are opening yourself up to possible credit card fraud, fake drugs, and a generally seedy business when it comes to prescription drugs over the net.

Have you asked you doc about the IND program?

Karyln:

I've been ordered Zelnorm (Zelmac in Mexico) from medsmex.com for 5 mo. with no problems. The delivery is quick and efficient. And, no problems with charging on my credit card.

I have friends who are ordering other drugs from them and they report the same excellent service and they do not dispense fraudulent drugs.

Susan

I used Zelnorm for about two years and it changed my life dramatically for the better. Now I've changed my diet (brown rice, whole wheat, blueberries instead of ice cream) and I take massive doses of Vitamin C, which makes you go. See Linus Pauling on Vitamin C.

My doctor told me yesterday that Novartis the company making Zelnorm is no longer manufacturing it and that I will no longer be able to buy it from Mexico. I have IBS with constipation only and Zelnorm is the ONLY drug that has worked for me. I am wondering if there are "Eastern hebal medications" that people use for this problem and how to find them. I am totally panicked!