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Zelnorm Problems
by Anne Madison
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Overview
When it appeared in 2002, Zelnorm was the only FDA-approved prescription medication for irritable bowel syndrome. Many women saw it as a life-saver, but for many others, serious side effects left them wondering if the cure was worse than the illness. Problems with Zelnorm led to an eventual recall of the medication, but even that may not be the end.
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Identification
Zelnorm is the brand name for tegaserod maleate, a prescription medication used to treat constipation. It's intended for short-term treatment of irritable bowel syndrome with constipation or for chronic constipation in women under age 65. It works by promoting the movement of fecal matter through the bowels.
Zelnorm is intended for use by women and hasn't been tested for efficacy in men.
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Side Effects
From the beginning, Zelnorm has caused serious side effects. In 2004, the FDA required Novartis Pharmaceuticals, the makers of Zelnorm, to change their labeling by adding a new warning about the potential for complications from the drug.
Zelnorm has been found to cause diarrhea in many patients, sometimes developing into a serious enough problem to require hospitalization for treatment of dehydration. In addition, Zelnorm can cause rectal bleeding and a possible worsening of abdominal pain. These are symptoms of ischemic colitis, when the intestines don't receive the proper supply of blood and oxygen. A link between Zelnorm and ischemic colitis was suggested but not proven.
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Dangers
In early 2007, Novartis released the results of 29 clinical studies that showed even more frightening dangers from taking Zelnorm. It appeared that taking Zelnorm increases your risk of suffering a heart attack, stroke or severe chest pain, which could lead to a heart attack. Among 11,614 women who took Zelnorm and 7,031 women who took a placebo, 13 women on Zelnorm suffered these events, and only one woman on a placebo suffered chest pain that went away on its own. While the numbers are small, they are significant enough to warrant attention.
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Recall
On March 30, 2007, the FDA requested a voluntary recall of Zelnorm, and Novartis agreed to stop selling the product. The FDA recommended that all patients currently being treated with Zelnorm discuss alternative plans with their doctors, and that the doctors should transition those patients to other therapies. They also suggested that any patients taking Zelnorm who experienced symptoms of an impending heart attack, such as chest pain, dizziness or shortness of breath, should seek immediate medical help.
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Potential
The FDA recognizes that for some patients, the risk from Zelnorm is low and no other therapy offers the same relief. They announced plans to work with Novartis to allow these patients to receive Zelnorm through a special program. Also, the FDA may allow Novartis to work toward reintroducing Zelnorm at a later date in a limited manner if a population group can be identified for whom the benefits of Zelnorm outweigh the risks.
