Zelnorm: The Benefits no longer Outweigh the Risks

East Hanover, NJThe United States Food and Drug Administration (FDA) has announced that, at its request, Novartis Pharmaceuticals has stopped sales of Zelnorm. The action was taken after a study showed increased risk of serious side effects in people taking Zelnorm.

The study, conducted by Novartis and submitted to the FDA, found that patients treated with Zelnorm had a higher risk of heart attack, stroke, and chest pain than patients who were treated with a sugar pill. As a result, doctors are now recommending that patients stop taking Zelnorm immediately. The FDA has asked Novartis to take Zelnorm off the market and Novartis has agreed.

According to a public health alert at the FDA website, of the 11,614 patients in the study who took Zelnorm, 13 had serious, life-threatening cardiovascular side effects including heart attack (one person died), severe heart chest pain that can lead to a heart attack, and stroke. The concern is that people taking Zelnorm had a higher risk of those side effects than people who were not on Zelnorm. The people in the study were taking Zelnorm on a short-term basis, for between one and three months.

In its release about Zelnorm, the FDA noted that the benefits of this drug no longer outweigh the risks, based on the data in the study.

The FDA announced that the following steps should be taken:

• Patients who are currently using Zelnorm should contact their physician to discuss alternative treatment options;
  
  
• Patients taking Zelnorm should seek emergency medical attention if they experience severe chest pain, shortness of breath, dizziness, or other symptoms of a heart attack or stroke; and
  
  
• Physicians who have patients taking Zelnorm should transition those patients to other therapies as appropriate.

Patients who have Zelnorm in their home should contact Novartis for information on how to return unused portions for reimbursement.

Other countries are following the United States in pulling Zelnorm (known in some countries as Zelmac) off the shelves. In Australia, doctors were contacting patients individually to ask them to stop using the drug. Singapore and Barbados also announced that the drug was being taken off the market, as did Canada.

Zelnorm is known generically as tegaserod maleate and is made by Novartis Pharmaceuticals Corporation. It is used for the short-term treatment of women who suffer from irritable bowel syndrome with constipation and also for patients under the age of 65 who suffer chronic constipation. Zelnorm works by reducing pain levels and increasing the speed of the G.I. tract. It is a selective serotonin receptor agonist that stimulates the release of chemicals in the intestines that aid in the movement of stool through the bowel.

If you are currently taking Zelnorm, contact a doctor to discuss your options.