The FDA (Food and Drug Administration) asks Novartis Pharmaceuticals in March 2007, to stop the sale of the irritable bowel syndrome drug Zelnorm. Zelnorm increases the risk of heart attacks, strokes, and other cardiovascular side effects.
Over 18.000 patients in over 29 clinical studies were said to have had over eight times more of a chance to have a stroke or heart attack compared to those who are not on the drug.
The FDA approved Zelnorm in 2002 for the short-term treatment of women who were suffering from irritable bowel syndrome, abdominal discomfort, and constipation as well as bloating.
The new patient information advises patients who get new or increased stomach pain or blood in their stools to stop taking Zelnorm right away and to immediately contact their doctor to determine if they may have a serious problem. In addition, the new labeling advises patients to stop taking Zelnorm and to call a doctor right away if they experience diarrhea that leads to lightheadedness, dizziness or fainting
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