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New Risk Information on Zelnorm for IBS for Women
      07/11/04 02:18 PM
HeatherAdministrator

Reged: 12/09/02
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New Risk Information on Zelnorm for IBS for Women

11 Jul 2004

New risk information will now appear in the labeling for the drug Zelnorm, or tegaserod maleate. This medication is used for the short-term treatment of women with irritable bowel syndrome whose primary bowel symptom is constipation.

The new labeling will contain a warning about the serious consequences of diarrhea in these patients, including hypovolemia, hypotension and syncope. The labeling also warns that patients on Zelnorm who develop hypotension or syncope should stop taking the drug. And patients who have or frequently experience diarrhea should not be started on Zelnorm.

The labeling will also contain a new precaution on ischemic colitis in patients receiving Zelnorm. Although a causal relationship has not been established, the drug should be discontinued immediately if the patient develops symptoms of ischemic colitis. These include rectal bleeding, bloody diarrhea, or new or worsening abdominal pain.

The new information will also be incorporated in a revised leaflet for patients.

Additional Information:

All about Zelnorm for IBS: http://www.helpforibs.com/footer/zelnorm.asp

MedWatch Safety Alerts Zelnorm (tegaserod maleate)
http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#zelnorm

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