The FDA ( Food and Drug Administration ) has informed patients and health care professionals that the sponsor of Zelnorm ( Tegaserod ), Novartis Pharmaceuticals, has agreed to stop selling Zelnorm.

Zelnorm is being taken off the market because a new safety analysis has found a higher chance of myocardial infarction, stroke, and worsening heart chest pain that can become a myocardial infarction in patients treated with Zelnorm compared to those treated with placebo.

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 myocardial infarction or stroke.

Zelnorm is a prescription medication approved for short term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years with chronic constipation.

In late February and early March 2007, Novartis Pharmaceuticals gave FDA the results of new analyses of 29 clinical studies of Zelnorm for treatment of a variety of gastrointestinal tract conditions; the data from all the studies were combined to assess the chance of side effects on the heart and blood vessels. In each study, patients were assigned at random to either Zelnorm or a sugar pill they thought was Zelnorm. These 29 studies included 11,614 patients treated with Zelnorm and 7,031 treated with placebo.
The average age of patients in these studies was 43 years and most patients ( 88%) were women.

The number of patients who suffered a myocardial infarction, stroke or severe heart chest pain that can turn into a myocardial infarction, 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 placebo.
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 myocardial infarction, and three had a stroke.
Among the patients taking the placebo, only one ( or 0.01% ) had symptoms suggesting the beginning of a stroke that went away without complication.

Source: FDA, 2007


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