Should You Stop Using Zelnorm?

By: Jessa Goddard, Medical Reporter
By: Jessa Goddard, Medical Reporter

Knoxville (WVLT) - A popular drug used to treat irritable bowel syndrome has been pulled from the US market, amid new evidence it raises the risk of heart attack and stroke.

Zelnorm is used by thousands of women to treat one of the most common intestinal disorders.

Medical Reporter Jessa Goddard takes a look at the risks, and what to do if you're taking the drug.

The FDA's decision is based on an analysis of 29 Zelnorm studies that showed a higher chance of cardiovascular events, such as heart attack, stroke or severe chest pain.

Irritable Bowel Syndrome (or IBS) is an intestinal disorder that causes abdominal pain or discomfort, cramping or bloating, and diarrhea or constipation.

Family Medicine Doctor Randy Pardue says Zelnorm is one of the most commonly prescribed drugs used to treat the disease. "For women with constipation-prone irritable bowel syndrome, it's been very effective."

The analysis of 29 studies turned up 13 cases of heart attack and stroke in about 11,600 patients who took the drug.

One of the 13 died.

The FDA describes the number of dangerous events as "quite small."

But says the rate of cardiovascular events is about 10 times higher in patients taking Zelnorm.

"It very much surprised me, and the issue of the heart issues and stroke and such is not something I've even been concerned about in that sense. And so hearing about this is very surprising."

Patients taking Zelnorm should talk to their doctor immediately.

Though, it will no longer be widely available, patients who have no other treatment options could still get access to the drug.

"At this point, they do not know. I think there might be some speculation, but I think it's much like with the drug Vioxx, it's simply speculation at this time," Dr. Pardue.

Drug maker, Novartis, says no evidence proves Zelnorm caused heart attack or stroke and the cardiac events were not significantly different from the general population.

The FDA says it's likely to allow the company to continue selling Zelnorm to patients, if their disease doesn't respond to any other treatment, and if the benefits outweigh the risks of serious side effects.

Access would be done through a special program.


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  • by Susan Location: Nashville on Jun 4, 2007 at 07:10 PM
    I too had been taking Zelnorm for about eight months before I found out about the recall when I went to the pharmacy to geta perscription refilled. I have been experiencing chest pain and severe shortness of breath for the past 2-3 weeks and have been seeing my doctor he is having no luck finding out what is causing the medical problems that i am experiencing. I read the email on the sight from a woman who said her symptoms of chest pain finally went away, I was wandering if she too was experiencing a shortness of breath as well as the pain? If so maybe there is hope for me as well.I am also having troupble finding any information on the specific types of problems these other patients experienced. If I could locate something I was hoping I could show my doctor so he might know more about these other people and see if my symptoms are in any way similar to theres. I am a complete wreck (physically) now and am unable to do much of anything these days. I just need some answeres and no one seems to want to come up with any...
  • by Jeannette Tucker Location: Pine Knot, KY on Apr 13, 2007 at 11:25 PM
    Thank you for telling on your news program about Zelnorm, I have been on it about 3 years. I had been having chest pain and anginia pain. I could not get my bowels to move and after my dr. gave me some other stuff to help them move, I just had a strong feeling to quit taking the Zelnorm, I had not heard anything bad about Zelnorm at the time, it was just a feeling I had. About 2 weeks after I quit taking it you anounced on your 6pm news about it. I have been off of it about 3 to 4 weeks and I noticed the other day that the heart pain and the anginia pain are gone. Thank you again for telling us about Zelnorm, you may have saved my life.

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