DRUG NEWS: GI drug gets stiff new warning

July 2004 
Volume 34  Number 7
Pages 27 - 27
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© 2004 Lippincott Williams & Wilkins, Inc. Volume 34(7)             July 2004             p 27 GI drug gets stiff new warning [DRUG NEWS: IRRITABLE BOWEL SYNDROME]

Indicated for irritable bowel syndrome, Zelnorm (tegaserod) will now carry new labeling to warn about a serious potential adverse reaction: diarrhea severe enough to require hospitalization. The new labeling also warns about the possibility of reduced blood flow to the intestines, an adverse reaction reported in over 20 people using Zelnorm. Three of these patients needed surgery and four died. However, whether Zelnorm was responsible for the ischemia is unclear.

Because the drug's benefits outweigh its risks, it will remain on the market, according to the director of the FDA's gastrointestinal (GI) drug division. But patients taking Zelnorm should stop taking it immediately and call their health care provider if they experience ...

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