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Discussion Starter · #1 ·
The New York Times are reporting that the IBS-C drug Zelnorm has been withdrawn by Novartis at the request of the FDA:WASHINGTON (AP) -- Swiss pharmaceutical maker Novartis AG will stop selling a drug to relieve constipation after it was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.This is the first I had heard of this - a NY Times reporter emailed me and asked for a comment. We've never had Zelnorm in the UK but I know it has helped a lot of people in the US.Has anyone else heard news of this? It seems ridiculous that we might be going through the whole Lotronex approved - withdrawn - approved scenario again...Update - I've checked the www.novartis.com website and it's confirmed, they're withdrawing it. This is not good news.
 

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Very dissappointing.It would be nice if the FDA would take IBS as a serious problem like they do erectile dysfunction. Those drugs can cause blindness and heart problems but they don't take those drugs off the market. Every year it seems they approve a new one. I mean how many men are really unable to work because of erectile dysfunction, but it is worth death to medicate that. IBS on the other hand, is not seen as serious enough to really need treatment by those that the FDA listens to. They certainly don't want to listen to the patients, well until they get thousands of letters, like they did with Lotronex.*sigh*Praying that Amitza isn't next on the chopping block. At least this time there is something that could be an alternative on the market.Of course with this no drug company is going to do any more research on IBS drugs, there is no pay off in the end if the FDA acts like this.K.
 

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Very sad...very very sad.I think the 5ht market is pretty much done for.Not like it wasn't already in rough waters, but like Kathleen said, who's going to want to make such a huge investment in research/development when these drugs are withdrawn from the market because they're facing pressure from the FDA?
 

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Oh. I can't really believe it. This makes me very sad. Even though the drug stopped working for me on it's own, there are so many people who need it on it's own or in combination with other drugs, like Amitiza or whatever. I'm worried about my friends on the Board who use this drug to good effect.Dana
 

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OK, I am totally freaking out here. I have taken Zelnorm for 4 years and it is the ONLY THING THAT HAS HELPED ME. I can't handle the thought of going back to life before Zelnorm. I wrote a letter back when Jeff was talking to the public citizen group about my success with zelnorm. Many other people wrote also. What can we do??
 

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Call Norvatis at 1-800-742-2422. I called and the guy said they have already received thousands of calls about this. They are logging all calls and giving this info to the FDA. He said to tell people to CALL and make your voice heard. The more people that are VOCAL about this the better chance we have of this being looked at again. I intend to bombard them with calls every damn day! This just kills me. Look at the drugs on the market that have DEATH as a possibility. Hell, aspirin kills people. They are talking about 11 people out of 12,000 that had some sort of heart problem. The placebo group had 1 problem of this sort. But, they don't even know if it was the Zelnorm that caused those 11 people to have those problems! GRRRR....
 

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I know for me, Amitiza is a superior drug to Zelnorm, but it requires a regimen to turn lemons (Amitiza) into lemonade (Colonic motility). A bare bones explanation of my research into the regimen, is that Amitiza increases visceral sensitivity that causes decreased gastric emptying (producing the well-known side effect of nausea). You rock on your sides such that after 1 hour a sigmoid spasm is induced, (which is necessary for the cervical traction to function). After the traction session, there is gastric emptying of coffee, causing ileal blood flow associated with a retro-peristaltic wave, caused by an anally directed contraction, (the opposite of the Law of the Intestine). This causes ICR (ileo-cecal reflux). A pre-requisite of the regimen is that Questran be taken at the prior meal and this bile acid binder (during the liquid phase of feces) reduces neurotensin release at the ileum. However, since the feces reaches the colon where water absorption occurs, the binding does not exist upon reflux into the ileum, where neurotensin is involved in bile acid reuptake. Neurotensin at the ileum also causes NANC (non-adrenergic/non-cholinergic) relaxation which inhibits an anally directed inhibition of contraction, where nitric oxide acts as a retrograde neurotransmitter. The nitric oxide inhibition results in an immediate 25% increase in colonic motility.
 

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I want to die- i cannot deal with living in hell..i finally found a combo that works and its even up in the air if the dr will continue me on reglan. so if the zelnorm is gone and the reglan is gone I guess it will be enemas for the rest of my sorry life... I need a motil;ity drug- amitizia is not a motility drug not to mention most of the folks on this board say it gave them nausuea and only works in combo with somtehing else- how can they do this??????so much for quality of life-
 

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These are the sort of remarks you all need to make to Novartis and the FDA. Let's not give up. Jeff Roberts was instrumental in organizing people to lobby for Zelnorm and we won (thanks to Jeff)!!! If enough people are upset and willing to have a heart attack rather than have Zelnorm taken away then that is saying something HUGE (thatchickali, I AGREE WITH YOU). Call Novartis and say it in those terms---however you are being personally affected by this. I am going to write letters to both the FDA and Novartis about this. We need to get going!
 

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I just sent an e-mail to the fda and I will try again with the phone call- got a message they were in a meeting....just google fda and youll find their website- i found a place to contact them and sent it. what else can we do??????I am sooo depressed right now-
 

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Discussion Starter · #17 ·
The New York Times reporter is looking for reactions from people on this and has given me permission to post his name and number.If anyone wants to talk about Zelnorm then you can contact Gardiner Harris, Science Correspondent, email: gardiner###nytimes.com or call: 202-862-0443 (desk) 917-568-7966 (cellphone).
 

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I e-mailed my house rep and e-mailed that reporter..... I feel ill. this whole thing is like a nightmare and as i said earlier post the dr may take my reglan too which leaves me with the enema option for everyday life... why bother getting up in the morning???
 

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Discussion Starter · #19 ·
The FDA have issued a statement which includes this..."The number of patients who suffered a heart attack, stroke or severe heart chest pain that can turn into a heart attack was small. However, patients treated with Zelnorm had a higher chance of having any of these serious and life-threatening side effects than did those who were treated with a sugar pill. Thirteen patients treated with Zelnorm (0.1%) had serious and life-threatening cardiovascular side effects; among these, four patients had a heart attack (one died), six had a type of severe heart chest pain which can quickly turn into a heart attack, and three had a stroke. Among the patients taking the sugar pill, only one (or 0.01%) had symptoms suggesting the beginning of a stroke that went away without complication.There may be patients for whom no other treatment options are available and in whom the benefits of Zelnorm treatment outweigh the chance of serious side effects. FDA will work with Novartis to allow access to Zelnorm for those patients through a special program.FDA has also 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 whom the benefits of the drug outweigh the risks. However, before FDA makes a decision about limited re-introduction, any proposed plan would be discussed at a public advisory committee meeting."Full statement here: http://www.fda.gov/cder/drug/advisory/tegaserod.htm
 
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