Zelnorm Pulled From Market

Lee Coleman

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The FDA said today that the Novartis Pharmaceuticals Corporation has agreed to stop selling Zelnorm. New safety analysis has found a higher chance for stroke, heart attacks, worsening heart chest pain that can become a heart attack. Zelnorm treats irritable bowel syndrome with constipation.

"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."