Why is Zelnorm being taken off the market?

The U.S. Food and Drug Administration (FDA) is telling consumers to stop taking Zelnorm - a short-term treatment for irritable bowel syndrome - immediately after manufacturer Novartis pulled the medication from the market. Results from many large studies suggest people taking Zelnorm have cardiovascular events, such as heart attack, stroke and chest pain, more often than people taking a placebo. Heart problems were very rare and occurred most often in people who already had heart disease.

If you ever experience symptoms of heart problems or stroke, seek medical attention immediately. These symptoms include severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking.

Is it safe to stop taking Zelnorm all at once?

Yes, you can safely discontinue Zelnorm all at once. It is not necessary to taper or gradually reduce Zelnorm.

Where can I get more information on Zelnorm?

The best person to answer your questions is your doctor. You may also get answers from the FDA Web site at www.fda.gov. Patients can return any unused and unexpired Zelnorm tablets to Novartis for reimbursement of out-of-pocket costs. More information can be obtained by calling the Novartis Customer Interaction Center at 888-NOW-NOVA (888-669-6682).

Back to top