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Chrissie Cole
Chrissie Cole
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Zelnorm Taken Off the Market

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The FDA has issued a public health advisory to notify health care professionals and patients that the sponsor of Zelnorm, Novartis Pharmaceuticals Corporation, agreed to take Zelnorm off the market.

The Zelnorm recall is due to new safety analysis that found a higher chance of heart attack; stroke and chest pain can become a heart attack in patients treated with Zelnorm. Compared to those patients treated with a sugar pill and led to believe it was Zelnorm.

Effective immediately, the FDA announces the following:

• At FDA’s request, Novartis Pharmaceuticals Corporation has agreed to stop selling Zelnorm.

• Patients being treated with Zelnorm should contact their physician to discuss alternative treatments for their condition.

• Patients who are taking Zelnorm should seek emergency medical care right away if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking or other symptoms of a heart attack or stroke.

• Physicians who prescribe Zelnorm should work with their patients and transition them to other therapies as appropriate to their symptoms and need.

In March 2007, Novartis Pharmaceuticals gave the FDA results of a new analysis that included 29 clinical studies of Zelnorm for treatment of a variety of gastrointestinal conditions. The data was combined to assess the chances of side effects on the heart and blood vessels.

In each study, patients were assigned randomly to either Zelnorm or a sugar pill that they “believed” was Zelnorm. The 29 studies included 11, 614 patients treated by Zelnorm and 7, 031 patients treated with a sugar pill.

The number of patients who suffered a heart attack, stroke or severe heart chest pain that can turn into a heart attack was small. However, patients treated with Zelnorm had a higher chance of having any of these serious and life-threatening side effects than did those who were treated with a sugar pill.

Thirteen patients treated with Zelnorm (0.1%) had serious and life-threatening cardiovascular side effects; among these, four patients had a heart attack (one died), six had a type of severe heart chest pain which can quickly turn into a heart attack, and three had a stroke. Among the patients taking the sugar pill, only one (or 0.01%) had symptoms suggesting the beginning of a stroke that went away without complication.

There may be patients for whom no other treatment options are available and in whom the benefits of Zelnorm treatment outweigh the chance of serious side effects. FDA will work with Novartis to allow access to Zelnorm for those patients through a special program.