# zelnorm ?



## lorilou (May 9, 2003)

Has anyone successfully gotten zelnorm through the IND program with the FDA? I gave the paper work to my dr. and just called to see if they got it mailed out. btw does it have to come from a gastro or can a gp request it?also after they get the paper work how long does it take to get an answer back?Lori


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## Tiss (Aug 22, 2000)

I had all my tests run and did everything my dr. said to do in July and he has not yet submitted anything. His nurse said "he has to write a letter to go with it". I guess he doesn't have the time to do that for me yet I had the time (and money) to get the darn tests run. I'm calling back tomorrow. I wish I could give you a positive answer but I am waiting myself.


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## Joan Mack (May 20, 2007)

I am beyond myself with pain, horror and fear of the entire medical establishment. The choice seems to be getting ripped off by the out of country establishments or getting down on your hands and needs to the doctors. Some choice


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## lorilou (May 9, 2003)

the dr. called back- the fda denied his request for zelnorm IND- there is another route he says he can try with the drug co. itself- he says he will try it.....Pleease God bring back zelnorm for all of us!!!Lori


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## annie7 (Aug 16, 2002)

Joan--you're right. i'm beyond fed up with the medical establishment myself.and Lori--sorry your ind was denied. so glad you have a dr who's willing to pursue it further--sounds like he's one in a million. i'm over 55 --to old for the ind criteria and my dr won't take it any further--and i finally gave up on on trying to find one who would. all the drs around here seem to agree with the age thing. good luck! and yes, i hope and pray we can get zelnorm back for all of us.


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## Tiss (Aug 22, 2000)

I saw my doctor yesterday to ask him why the heck he hasn't submitted my bloodword, ekg, etc for IND Zelnorm to the FDA and he said "it is my fault (no sh*t sherlock!) and I promise to send it in THIS WEEK". I'm keeping my fingers crossed if I am approved or not! I'll let you know.


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## 13863 (Mar 23, 2007)

When I mentioned the Zelnorm IND program to my doctor, he didn't seem to think it had even started yet. So frustrating.


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## Tiss (Aug 22, 2000)

Florida Girl, Go the FDA website and there should be info about zelnorm. I made copies of the information myself and took it to my doctor.


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## Joan Mack (May 20, 2007)

I am keeping a poo-poo diary. Saw my GI guy today and he was not very helpful. He wants me to try different things and I will do that. He is very into dates so I will keep a poo-poo diary. He said that he would not do the 2 page form for me. I think I came down with this problem around menopause. I am too old for the Norvatis program. I am writing letters to politicans. The gi guy says it was not my fault and that he knows I eat right. He did say that he thought zelnorm might be back on the market in Europe at some time. I AM VERY UNHAPPY but what can I do except be


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## ibstimes (Oct 3, 2007)

Hey Joan,Keep the faith. You're absolutely right. The drug firms, the FDA, and most doctors are all part of a huge multi billion dollar conspiracy. Google them. You'll be amazed at the #### the pharma corporations do to fill their coffers. In a previous post I mentioned they haven't done anything notable since penicillin. Zelnorm? BEWARE!But there are solutions that are cheap, safe and natural.high fiber, lots of water, probiotics, enzymes, Omega 3 oils (fish), and a healthy ph balance to name but a few. Never do a colon cleanse -- they are all ripoffs. It is unecessary as our bodies do it naturally if we treat it rightGood Luck


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## Joan Mack (May 20, 2007)

I had severe gas pains today and a surprise (fecal) in the shower. I am wearing a face cloth in my undies. Take care everybody...this is just another drop in my medical basket. Did read about taking up to three tablespoons of olive oil and will try a little teaspoon now. Thanks for answering me.


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## libraryg (Jun 20, 2007)

A few months ago I tried for the IND too......& struck out.I am beyond the pale DISGUSTED with the med. communities' lack of giving a rat's ass about our suffering!


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## Joan Mack (May 20, 2007)

I now have a "case file " with an important politician. OmyGod pleeeeeeeeeeeasssee help me. I am keeping up my poop poop "log" (get it?) and maybe another doctor will help me. I am VERY UPSET. I think the whole thing is sexist (more than 1/2 the people who suffer from ibs are female) and prejudiced against anyone older than 55. I AM ALLERGIC TO DRUGS AND SHOULD NOT HAVE TO TRY STUFF.














Hey, what happened to the Freedom of Information Act when I as an individual could not get a copy of the 2 page IND exception form from the FDA. Sounds like the song from the Broadway show [b_]HAIR_[/b]. J o a n went to the FDA to get the IND form and what did she see...nothing but misery.Peace On...though I am angry I more horrified than anything else.


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## Tiss (Aug 22, 2000)

My doctor (hopefully) sent all my paperwork and tests in 2 weeks ago for the IND zelnorm program. I am keeping my fingers crossed. I'll let you all know.


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## Joan Mack (May 20, 2007)

Taking 1 zelnorm a day is not that effective but I am living through this mess. Am super busy but just want you all to know how highly I think of you. Hope you paperwork and recommendation comes through the FDA. These medical people are going to give me a heart attack with all their stuff.


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## not4me (Nov 21, 2007)

Ok, I've seen the paperwork, its an inch or so thick, not just a page or two like the FDA and Zelnorm websites would lead you to believe. Your physician MUST sit thru a training program (at least it is online) and have some kind of teleconference. They have to "pass the mustard" themselves, including submitting their own vitae. My dr's office has been working on it since early August, and I had my "initial appointment" yesterday. Then (and only then) could I have the lipid panel drawn and the ekg. Nearly four months of paperwork and run around just to get the DOCTOR approved, now we are working on ME. My test results are good as far as I know and I will go back next week to hopefully get my month's supply of medication. The patient consent form is approximately 10 pages. The meds will be free, but all other related costs, including physician care, ekgs, and a lipid panel every three months must be paid by the patient. Don't know about you guys, but my insurance sure won't tolerate that costs every three months, probably won't cover the first time either, but I'm willing to eat that cost.This is a long, drawn out process, and I truly hope that I will be approved since my doc has gone out on a limb for me.


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## bettyblue (Nov 13, 2007)

i, sadly, feel the same way. after numerous "specialists" and internists, i feel like giving up. my pain won't let me give up. they want me to take 1 tramacet daily to help, it takes at least 6 to let me have a normal day, and i have never gotten high or experienced withdrawals, it just works that way for me. i am considered an addict. i try to cope, but it's too hard, i'm broke and about to lose it. i'm only 28 years old. i need a painkiller that will work until i get my tests in jan. who knows what they will show? sorry..needed a rant


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## Joan Mack (May 20, 2007)

I give up...made a mistake when I typed earlier. I got stuck trying 1 zelnorm every other day and kept a log of my results. Ended up bowed over with bowel cramp which gave me reflux or stomach acid. Got a tab on the roof of my tongue from all the roughage. Oy vey iz mei or something. Peace on...


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## not4me (Nov 21, 2007)

It IS possible. Nearly four months of effort by my dr and staff (NOT a gastroenterologist) and the first bottle hit my hands yesterday. Maybe I was just lucky enough to be part of an under represented demographic? My biggest fear at this moment is the question "when will they take it away again?"


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## Tiss (Aug 22, 2000)

I started the process back in the summer--blood tests, ekg, etc. My dr. finally sent off all the stuff about a month ago. I called him yesterday for an update and he said that HE is waiting to be approved by the FDA. I think he is very frustrated with this process too. I wonder what he has got to be approved for?? I'm still getting my zelmac from medsmex. I'm glad someone has been approved. Gives me some hope.


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## not4me (Nov 21, 2007)

As I had stated earlier, its a MESS for the physician and their office. Getting THEM approved was the big hold up, lots of paper work, an IRB, lots of phone calls, etc. For me, they faxed my paper work and they got the reply the next day, meds came 5 days later. The patient consent form alone was approx 10 pages. There were also a lot of other exclusion criteria that the web site did not address. - fibromyalgia, heart attack or disease by OTHER members of your family under the age of 50 or 59 (I forget), neurological disease, diabetis, etc etc etc. I really expected to get bumped for some bizzarre technicality. We did NOT do any of my tests until I had my first appointment. I suspect, although I do not know it as a FACT, that they may not accept test results from prior to your application date, since I had recently had a full cardio workup and I needed yet another ekg.The physician is the one responsible for your care and they have to prove to the FDA that they are worthy of their trust and will follow the rules to the letter.


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## Joan Mack (May 20, 2007)

I sent a money order to the pharmacy group (mexmeds or whatever it is) and hope to get something soon. Tiss I am really worried and turned off. I feel so unpatriotic. How could the FDA do this to us? I will use mineral oil I think if I run out of zelnorm. Stool softeners are very hard on me.


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## muffinloaf (May 4, 2007)

Hi everyone, I am new to this list. I live in the USA, I have IBS-C and Zelnorm was truly a godsend for me. I did not have any undesirable side effects with Zelnorm. I am wondering about other people's experience with generic Zelnorm. I did order some generic from a company without any problems regarding shipping, billing charges, etc. However, the generic really did not work for me. According to the packaging, this generic is called Tagon-6 (tegaserod maleate). Is there a different generic Zelnorm available from a reputable company that is more effective? Thank you.


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