Zelnorm has been withdrawn

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NH66
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Date Joined Jan 2007
Total Posts : 52
   Posted 3/30/2007 11:47 AM (GMT -7)   
  Hi all,
 
 WASHINGTON (AP) -- Swiss pharmaceutical maker Novartis AG will stop selling a drug to relieve constipation after it was linked to higher chance of heart attack, stroke and worsening heart chest pain that can become a heart attack, federal health officials said Friday.
       www.novartis.com
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friendlygal
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   Posted 3/30/2007 12:35 PM (GMT -7)   
You're kidding!!!  I'm on zelnorm!  Do doctors know this??

NH66
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Total Posts : 52
   Posted 3/30/2007 1:10 PM (GMT -7)   
It was just came out today in the N.Y. Times
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sunshine323
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Date Joined Feb 2007
Total Posts : 79
   Posted 3/30/2007 2:25 PM (GMT -7)   
*sigh* I'm so tired of these drug recalls due to "increased risk of heart attack," when really it has more to do with lifestyle than the drug itself. This happened with celebrex and vioxx, and a couple others ... and i'm sure there will be like a hundred thousand unnecessary lawsuits that come out of it, too.

(note that this is coming from a pharmacist's daughter, and a drug rep's granddaughter, and my views might be a tad skewed)

Canyonbabe711
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   Posted 3/30/2007 3:40 PM (GMT -7)   

This is what i received today from the FDA warning site I am on.

I think Celebrex is still available but not Vioxx.
 
Canyon, all I did was make your link linkable. -- Lil

Post Edited By Moderator (7Lil) : 3/30/2007 7:00:15 PM (GMT-6)


Keriamon
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   Posted 4/2/2007 9:18 AM (GMT -7)   
Yeah, I like that "seek alternative treatment". Don't those goobers know that this was the last hope for most people that are on it?

They also did the same thing with Seldane which was a prescription allergy medicine. My mother took it for years without problems and never has found anything that works quite as well for her, and certianly nothing else that works as fast. And she has very severe allergies.

So, the FDA decides that it's better to die of constipation than from a heart attack? I'm glad that they do these tests so you know your risks, but why pull the product? Why not put severe warnings on the drug that people with any form of heart problem can't take it and that everyone else must be monitored regularly for blood pressure, chest pains, etc. and then let people and their doctors decide if it's worth the risk. Having to have surgery o yoru colon due to constipation surely has a higher risk of death and complications than Zelnorm.

You know, they don't seem to care if cholesterol meds damage your liver or if bariatric bypass surgery has a 1-in-50 death rate. I guess consitpation just isn't the "epidemic" of the day and doesn't have enough lobbying power to stay on the market for people who really do need it.

dbab
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   Posted 4/2/2007 9:33 AM (GMT -7)   
It is not unusual to pull meds when life risks are involved. You need to understand the FDA's position on this, I'm not a big fan of everything the FDA does but I know if it wasn't for them, I would still be eating my Peter Pan tainted peanut butter.

I'm sure there will be floods of advertising on TV, "If you took Zelnorm, call the Law Offices of ..." If the FDA doesn't stop this, can you imagine the devastation and the lawsuits on the FDA? The fact is, the med needs to be re-investigated. All inserts and labeling needs to be updated (if they decide to put it back on the market). Its not just as simple as, "they took my medication!!!"
"Des"
Co-Moderator ~ IBS Forum
Dx: IBS 1989, Diverticulosis 2004, Idiopathic Acute Colitis 2006, UCTD 2007
Meds: Plaquenil 400mg, Chlorzoxazone 500mg, Lyrica 50mg, Protonix 40mg, Naproxen 1000mg, Xanax XR 2mg, Miralax 17g, Supplements


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Keriamon
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Date Joined Jun 2005
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   Posted 4/2/2007 10:43 AM (GMT -7)   
It still seems unfair that they have left people with severe constipation in the lurch. At least when they took the anti-D medicine off the market, they did allow a few doctors to prescribe it to a few really severe individuals.

And doesn't the FDA panel include people that are not doctors? Are any of them even doctors? I don't know; sometimes I think the FDA treats us all--including doctors--as if we're a bunch of idiots. And Lord knows they succumb to political pressure, including lobbying groups.

Of course, like any governmental agency, there's a lot of room for improvement. They do come in handy when it comes to recalling tainted food. They just seem to be more spotty when it comes to allowing some medicines, but not others.

friendlygal
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Date Joined Dec 2006
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   Posted 4/2/2007 11:17 AM (GMT -7)   

A GI doctor from France told me that Zelnorm has not been pulled out in Europe.

For some reason, Zelnorm never worked for me for my constipation.  But I know it was a lot of people's last resort...


Canyonbabe711
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Date Joined Mar 2006
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   Posted 4/2/2007 11:13 PM (GMT -7)   
It is very possible that after some testing that it may come back for people that have no other choice. That is what I heard. It made me so dizzy I could not get out of bed without falling into the wall and that was half of a 3mg. I hope you all find something that will help. I know constipation is bad (I have IBS-C) but I don't think it is as bad as something that may be damaging your heart that can't be fixed.

7Lil
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Date Joined Apr 2005
Total Posts : 3269
   Posted 4/3/2007 8:01 AM (GMT -7)   
Hi Gracie's Mom,
Welcome to the IBS board!
I am astounded at the dosage of Zelnorm your daughter was taking. It doesn't surprise me that she was having chest issues. What has her doctor said the next step is? There has to be something other than Miralax that will work for her. I hear aloe vera works wonders.... some docs prescribed it for C. There are quite a few people on this board that suffer with C - hopefully someone will share what works for them.
I have nothing that can be helpful to you (that you haven't already tried)... I just wanted to welcome you and thank you for sharing.
Best of luck to you and your daughter!!!!
Co-Moderator for the IBS Forum
 
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Keriamon
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Date Joined Jun 2005
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   Posted 4/3/2007 8:21 AM (GMT -7)   
We had a guy on here about a month ago who is part Chinese and his dad dug up an old Chinese remedy for him for his D, I think it was. It involved breathing in the vapors of certain plants, and I think drinking something too. I seem to recall that he said that it wasn't that expensive and that you should be able to find it in the US if you go to a big city and go to the chinese herbalist. He was raised Western, and thought it sounded crazy, that breathing vapors would help, but he was out of options, he tried it, and it worked. Apparently it's been prescribed in China for centuries; nothing stays around that long if it doesn't work, I say. He did some more research and found that a few doctors have discovered this treatment as well and have some theories as to why it may work.

Anyways, you might want to go back through the postings from a month or so ago and see if you can find it and shoot him an e-mail about what his Dad thinks about treating C. There might be something that you can afford to try. Doesn't seem like you're left with any alternatives anyways.

friendlygal
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Date Joined Dec 2006
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   Posted 4/4/2007 2:25 PM (GMT -7)   

Gracie's mom, you sound like a great mom!  I just found out that Zelnorm is off the market in Europe, too.  So my prior posting was wrong when I said that it wasn't (a GI from Europe had told me it wasn't taken off the market there.  Either he was wrong, or they just took it off now).

I know that it may seem like zelnorm is the answer, but maybe there are more drugs out there that we don't know about?  I had a really bad C problem, so I know how Gracie feels in that regard!  I was tested for gastroparesis and I don't have that.  But my colon is terribly twisted and I couldn't go bowel for a month.

I'll pray for Gracie!  Keep us posted!


Keriamon
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Date Joined Jun 2005
Total Posts : 2976
   Posted 4/5/2007 8:08 AM (GMT -7)   

An article on Zelnorm. Gracie's Mom, note how few people actually had a problem with the drug. Obviously, though, because of the high doses your daughter was taking, and prior heart problems, she is much more likely to be one of the 13 people out of 11,614 who developed a problem. I hope they can find something else to get her moving, but it sounds like she needs such high doses of anything she takes to get her bowels to work, that she's likely to encounter severe side affects regardless.

But everyone else take heart that they might release it on a limited basis, so if you absolutely cannot function without it, and you don't have any heart problems, have your doctor campaign to have you made one of the exceptions. If my math is right, a person on Zelnorm has a .111% chance of developing serious heart-related side effects. So, right at one-tenth of one percent of a chance. The placebo group had a .014% chance of developing serious heart-related problems. While obviously Zelnorm increases your risk, all I can say is, good-grief. It increases your chances of having heart problems by just under one-tenth of one percent--so, 1 in a 1,000, I think. Obviously someone thinks that slight increase is more important than the permanent damage that chronic constipation can cause to your intestines. Of course, I guess they're always banking that you can have your intestines removed and go to a colostomy if your constipation gets too bad. What a way to live. Sometimes I think our society and medical community gets so obessesed with living forever that we forget to live well. Of course, deciding to risk your life in order to live it well right now is a different proposition for someone Canyon's age than for someone making that decision for a teen child. We all just have to do what we feel is right for us.

Anyways, just thought I'd pass that along; doesn't look like anyone much should really be worried about what their Zelnorm has done to them (provided my math's right; I admit, I'm not a math whiz, even with a calculator).
 
Keri, all I did was make your link linkable. -- Lil :-)

Post Edited By Moderator (7Lil) : 4/5/2007 9:18:34 AM (GMT-6)


Joan M
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   Posted 4/5/2007 9:19 AM (GMT -7)   
Hi, my doc have me a script for a mini-dose of the stuff you use for the prep for a colonscopy. I hope it works out for me. I think it is called Miralax. The zelnorm was super expensive but it worked so I paid for it. I also use konstyl (a metamuscile - spelling?) product.
 
I also liked Betra (an pain killer for arthritis) a lot and they got rid of that too so I use alleve which is a help but not as effective as the Betra was.

dbab
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Date Joined Jan 2004
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   Posted 4/5/2007 11:19 AM (GMT -7)   
Hi Joan,

I use Miralax and have been for a few years now and it does work for me. I hope you find some relief from it.

Take Care
"Des"
Co-Moderator ~ IBS Forum
Dx: IBS 1989, Diverticulosis 2004, Idiopathic Acute Colitis 2006, UCTD 2007
Meds: Plaquenil 400mg, Chlorzoxazone 500mg, Lyrica 50mg, Protonix 40mg, Naproxen 1000mg, Xanax XR 2mg, Miralax 17g, Supplements


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Joan M
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Date Joined Jan 2006
Total Posts : 1972
   Posted 4/6/2007 3:32 PM (GMT -7)   
hi dbab...I am in bad straights right now. My purge for a recent colonoscopy was not good enough for the doctor to really look at my colon. But the purge was enough to make me sick...I am having gas pains and erratic bowel movements. I think the problem was that I was instructed to stop taking my konstyle which I have been using for over 7 years. I intend to use up my zelnorm and then will switch to the new stuff. Have been taking the konstyle since Wednesday and hope it puts me back on track soon. I will have to do a two day prep for the next colonscopy. He said I could wait for three months. I am sure I'll really be screwed up after all that!

Glad to hear Miralax is working for you and hope it is not as expensive as Zelnorm was. Ugh these problems are a drag.

friendlygal
Veteran Member


Date Joined Dec 2006
Total Posts : 722
   Posted 4/6/2007 6:13 PM (GMT -7)   
Joan M, what do you mean that your "purge wasn't good enough for a colonoscopy"?  Are you having trouble clearing yourself out?  The stuff that people use around here for the colonoscopy prep is called "halfLytely."  But I hadn't gone bowel in a month so I had to take 4 dulcolax and some miralax for about 4 whole days, and then I used the halfLytely.  What a chore it was for me to get out some bowel.  Luckily, I am not on zelnorm, miralax, or laxatives now and have been going fine.  I hope it lasts!

jhmom
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Date Joined Oct 2004
Total Posts : 2244
   Posted 4/7/2007 8:35 AM (GMT -7)   
I can usually be found on the lupus board but just had to respond to this thread. I suffer from GI probs due to lupus and my GP wanted me to try Zelnorm, I took it for a month with no improvement so I stopped taking it. I know it worked well for others though and I hope you find something that works for you.

I do have a suggestion, I haven't tried it yet but my rheumy (lupus doc) gave me the ok to try it

I called my local "compounding pharmacy" and was told magnesium helps with constipation. It one of those things where you have to find your magic number of pills but it's natural, it won't hurt you and you can't overdose on it. Try looking it up on Google or if you have a local compounding pharmacy it might be worth the call. When I start it (as I still have some constipation issues from time to time) I will let you know how it works for me, until then I pray each of you find something that works well. Take care
Stacie

Trust in the Lord with all thine heart, and lean not unto thine own understanding ~ Proverbs 3:5 ~

DX: Hashimoto's 1999, Celiac Disease (gluten sensitivity)2003, Raynaud's 2004, Lupus 2005 and Sjogrens 2006
Meds:Imuran, Plaquenil, Flexeril, Sulindac, Levoxyl, Folic Acid and magic mouthwash (as needed)


poopienubbins
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Date Joined Apr 2007
Total Posts : 4
   Posted 4/7/2007 9:22 AM (GMT -7)   
I had a colonoscopy that the doc has to "redo" because I wasn't empty enough. I too was on Zelnorm, but it wasn't helping me, so I don't feel a big loss with the recall, although I feel tremendously for those of you who had found some relief. Unfortunately, I have not found my relief as of yet. The gastro found internal hemorrhoids, and polyps in the colon that he could view. I have some serious pain in the lower left quadrant, left hip and left side of my back. Oh yeah, and he said my colon is about nine feet long, and the normal colon is only about five feet. I wish us all well. yeah

Joan M
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Date Joined Jan 2006
Total Posts : 1972
   Posted 4/7/2007 2:15 PM (GMT -7)   
dear everybody...I did what the doctor told me, 4 ducolax tablets and 1 plastic thing of miralax (64 oz geterade). He did not give me a script for go-lightly. I had a large formed stool even though I took all that stuff so I have to have a redo. I hope I get something more effectively for next time. I have been taking my konstyl and hope to have a normal bowel movement one of these days. HOPE, HOPE, HOPE!

7Lil
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Date Joined Apr 2005
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   Posted 4/7/2007 2:49 PM (GMT -7)   
Joan, maybe you should consider getting yourself some Phosphosoda. It's over the counter and you can buy it at most drug stores. Just a thought... it's what I used for my scope and it worked great.
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dbab
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Date Joined Jan 2004
Total Posts : 4151
   Posted 4/9/2007 5:46 AM (GMT -7)   
Joan, When you say 1 plastic thing of Miralax, are you talking about one capful or one bottle (whole thing)? I'm sorry I wasn't sure. One capful will not clean you out, people with chronic constipation are told to take 1-3 capfuls daily. I just wanted to clarify.

Thanks
"Des"
Co-Moderator ~ IBS Forum
Dx: IBS 1989, Diverticulosis 2004, Idiopathic Acute Colitis 2006, UCTD 2007
Meds: Plaquenil 400mg, Chlorzoxazone 500mg, Lyrica 50mg, Protonix 40mg, Naproxen 1000mg, Xanax XR 2mg, Miralax 17g, Supplements


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gotta go!
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Date Joined Apr 2007
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   Posted 4/9/2007 5:59 PM (GMT -7)   
Phosphasoda worked very well for me.  very quickly. 

Joan M
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Date Joined Jan 2006
Total Posts : 1972
   Posted 4/11/2007 2:33 PM (GMT -7)   
I took the entire plastic bottle of Miralax with 64 oz of green geterade plus 4 dulcalax tablets. It just was not enough. Hope the next one works better. My bowel movements are improving. Did I mention that each one of these colonoscopies cost either $100 or $150 (I'm afraid to find out!)? So that is another burden for me. To me that is a lot of money which I would prefer to spending elsewhere.
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