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Zelnorm FDA Alerts

The FDA Alerts below may be specifically about Zelnorm or relate to a group or class of drugs which include Zelnorm.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Zelnorm

Zelnorm (tegaserod maleate)

[Posted 03/30/2007] FDA notified healthcare professionals and patients that Novartis has agreed to discontinue marketing Zelnorm, a drug used for the short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years of age with chronic constipation. FDA analysis of safety data pooled from 29 clinical trials involving over 18,000 patients showed an excess number of serious cardiovascular adverse events, including angina, heart attacks, and stroke, in patients taking Zelnorm compared to patients given placebo. Patients taking Zelnorm should contact their healthcare professional to discuss treatment alternatives and seek emergency medical care if they experience severe chest pain, shortness of breath, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke. Healthcare professionals should assess their patients and transition them to other therapies as appropriate.

[March 30, 2007 - FDA]

Zelnorm (tegaserod maleate)

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]

More Zelnorm Resources