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U.S. Department of Health and Human Services

Safety

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Zelnorm (tegaserod maleate) Apr 2004

Audience: Gastroenterologists and other healthcare professionals

The FDA and Novartis notified healthcare professionals of an important drug warning and prescribing information for Zelnorm, a serotonin 5-HT4 receptor partial agonist indicated for the short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation. This new information relates to a Warning for serious consequences of diarrhea and a Precaution for rare reports of ischemic colitis in post marketing use of Zelnorm.

[April 26, 2004 - Letter - Novartis]
[April 2004 - Revised Label - Novartis]
[April 28, 2004 - Drug Information Page - FDA]