Fallout from the Zelnorm recall

April 5, 2007

Lost in the coverage are the IBS sufferers who depended on Zelnorm:

Some IBS patients say they have been calling the FDA asking for the drug’s return to market. Jeffrey Roberts, founder of the Irritable Bowel Syndrome Self Help and Support Group, says he is encouraging the Web-based organization’s 20,000 members to write to the FDA to complain.

Other patients are returning to the makeshift remedies they used with mixed success before Zelnorm became available in 2002, including taking fiber supplements and laxatives. Some patients have also expressed interest in probiotics, the dietary supplements that contain bacteria that can help smooth digestion. But doctors caution that there is limited evidence that the supplements are effective in IBS.

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{ 15 comments }

1 John J. Coupal April 5, 2007 at 3:39 pm: The FDA has a “one size fits all” mentality when it comes to drug recalls.

I’m sure that there are many IBS sufferers who could safely take Zelnorm. The problem lies in being able to identify those particular people from those for whom Zelnorm could have toxic adverse effects.

The science of personalized medicine is still young.

FDA banned PPA (phenylpropanolamine) from OTC diet drugs because of rare stroke occurring in women. FDA’s plan banned PPA for women – and for men.

“One size fits all.” Just like the suits on a rack.
2 Lisa April 5, 2007 at 5:02 pm: John,
You’re absolutely right, but letting those patients who could safely take Zelnorm do so would imply that patients and their doctors are capable of making those decisions. The FDA certainly treats patients like we’re dumb as a bag of rocks, but it doesn’t treat doctors much better. All those years of medical education still don’t really qualify you to decide which drugs are right for which patients- only the FDA knows that.
3 Anonymous April 10, 2007 at 12:21 pm: Does anyone know how/where to get Zelnorm outside the US?
4 Toni April 14, 2007 at 8:52 am: Frankly, I took Zelnorm for a year and found the effectiveness to be inconsistent and not worth the $50 copay. But, my doc told me to keep taking it because it was at least helping with my bloating.

I had a heart attack in Dec. and was just diagnosed with PCOS. I only found about about the recall last night because I called my pharmacy for a refill.
5 Anonymous April 20, 2007 at 8:55 am: I just found out about the recall yestday and have missed 2 doses and feel terrible again! It really helped me.
6 Anonymous April 22, 2007 at 8:22 pm: I have been on Zelnorm for a year, though I HAVE had side effects I believe were from that, increased rectal bleeding,bouts of diareah and pain, I still took it to help the IBS, especially the bloated belly I once had, and will get again with out it.
CA
7 desperate April 23, 2007 at 8:26 pm: I have been taking zelnorm since it was released in 2007 I call it my mircle drug. Nothing else has worked, even trying to control it with diet. All foods do and do not effect my IBS. I am looking for another solution. If there is another solution out there please let me know.
desperate!!!
8 Anonymous April 25, 2007 at 2:10 pm: I was a male using Zelnorm for the past 2 years because the pain pills I have to take block me up. My wife started me on a vitamin pack regiment from a local vitamin supplier that supplies chiropractors and it completely eliminated constipation! I am not a big pill taker but figured I would try and am THRILLED with the results!
9 Anonymous April 26, 2007 at 10:43 am: What was this vitamin pack?

I just found out and definitely need an alternative!
10 Anonymous April 30, 2007 at 11:42 am: I have been taking zelnorm for a couple of months and it did help with constipation and bloating. However, the last month I also started having heart problems and rectal bleeding. Once I heard about the recall I stopped taking it because heart attacks run in my family. I need an alternative.
11 Jane H. May 6, 2007 at 9:31 pm: I am a 47 year old female who had suffered from IBS for my entire life. I lived in embarrassment and misery until I found Zelnorm. For the first time in my life I felt wonderful. Since the FDA recalled Zelnorm, I have seen my doctor and I have tried two other medications that work minimally compared to the Zelnorm. I am again having problems with constipation, bloating, gas, etc. I have even tried flax seeds and mineral oil, but nothing works the way Zelnorm did. I’m sure the FDA fears lawsuits, but have they considered the multitudes who took Zelnorm safely…and how this recall has returned our lives to one of constant discomfort.
Jane H.
Baton Rouge, LA
12 Anonymous May 18, 2007 at 7:47 pm: The FDA is denying me a medication that I absolutely need to survive. I am a 17 year male with severe IBS, and the only thing that ever worked was Zelnorm. Since the recall, I have relapsed worse than ever, lost my will to live, and experience daily pain that non-IBS-sufferers could never understand.

The federal government needs to stop “protecting” its citizens, I am the one who must decide what risks I take and what medications I choose to put in my body. Without this medication, I have no future, I have no happiness, no peace.

Do you know what it is like to be 17 and feel 80?
13 rjihrke June 20, 2007 at 8:14 am: I just wanted to say that I have suffered fom the side effects of Zelnorm. I was hospitalized for a TIA (transient ischemic attack) which is a blood clot that was able to resolve on its own with no lasting effects. TIA is said to be a warning sign of furure stroke risks. I agree that the drug DID help with the IBS that I was suffering from, I did not know of these potential and very dangerous side effects.
14 Anonymous July 22, 2007 at 11:45 pm: I have suffered from chronic idiopatic constipation my entire life. I live a very healthy lifestyle, eats tons of fiber (on average 50 grms a day), drink plenty of water and exercise vigorously and regularly, at least 5 days a week.

And yet, when it comes to going to the bathroom… nothing ever happens!!! Always constipated, bloated, uncomfortable.

That is, until I was put on Zelnorm. It was like a miracle!! It worked like a dream. Going to the bathroom normally without any laxatives, irritants that leave you even more bloated.

Life is miserable again! I was in total shock when I went to renew my prescription, and told me that it was no longer available.

Does anybody know how to get it from Canada, Mexico, anywhere???
15 Anonymous August 4, 2007 at 11:44 pm: You can order Zelnorm from http://www.medsmex.com. It goes by the name Zelmac, but it’s same medicine made by Novartis.