To ensure that women and health professionals have me most current and complete information available when taking or prescribing Zelnorm (tegaserod maleate) for short-term treatment of irritable bowel syndrome (IBS), the FDA has revised the drug's labeling to include new risk information.
The revisions include:
* A new warning about the serious consequences of diarrhea associated with Zelnorm. This warning states that serious consequences of diarrhea, including decreased blood volume, low blood pressure, and fainting, have been reported in the clinical studies and during marketed use of Zelnorm. In some cases, these complications have required hospitalization for rehydration. Zelnorm should be discontinued immediately in patients who develop low blood pressure or fainting, and the drug should not be initiated in patients who are currently experiencing or frequently experience diarrhea.
* A new precaution about ischemic colitis and other forms of reduced blood flow to the intestines (intestinal ischemia) because patients have reported these complications from use of the drug.
* Changes to the adverse reactions section describing the adverse events reported after the drug's approval.
* New information in the "Information for the Patient" leaflet.
Made by Novartis Pharmaceuticals Corp. of East Hanover, N.J., Zelnorm increases the movement of stools through the bowels. The drug does not cure IBS, nor does it treat diarrhea-prominent IBS. Rather, it reduces bloating and constipation. Zelnorm should not be taken by women who are currently experiencing or frequently experience diarrhea. Its safety and effectiveness in men is not established.
COPYRIGHT 2004 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group
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