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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