March 30, 2007--FDA issued this public health advisory to inform patients and health care professionals that Novartis Pharmaceuticals Corp., has agreed to stop selling Zelnorm. Zelnorm is being taken off the market because evidence has found a higher chance of heart attack, stroke, and worsening heart chest pain that can become a heart attack in patients treated with Zelnorm compared to those treated with a sugar pill they thought was Zelnorm. 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 old. In late February and early March 2007, Novartis gave FDA the results of new analyses of 29 Zelnorm clinical studies for treatment of a variety of gastrointestinal tract conditions and to assess the side effects on the heart.
The number of patients who suffered a Zelnorm 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.
