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tegaserod (ZELMAC, ZELNORM)

Drug and Dietary Supplement Profiles

A comprehensive review of the safety and effectiveness of this drug. If the drug is not a Do Not Use product, information on adverse effects, drug interactions and how to use the medication are included.
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  • tegaserod (ZELMAC, ZELNORM)
    We list this drug as a Do Not Use drug because irritable bowel syndrome is not life-threatening, the drug is minimally effective, and it causes diarrhea, ovarian cysts and lack of blood flow to the intestines.

Disease and Drug Family Information

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  • Irritable Bowel Syndrome [hide all summaries]
    The FDA has approved drugs for both diarrhea-predominant and constipation-predominant IBS. The former, alosetron (LOTRONEX) , had to be removed from the market after it caused serious constipation and a condition of decreased blood flow to the intestine called ischemic colitis. The latter, tegaserod (ZELNORM), has also been associated with ischemic colitis and severe, disabling diarrhea, and it is barely effective.

Worst Pills, Best Pills Newsletter Articles

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Additional Information from Public Citizen

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  • [hide all summaries]
    Statement of Sidney Wolfe, MD, director of Public Citizen’s Health Research Group
  • [hide all summaries]
    tegaserod was associated with nine cases of ovarian cysts in women in clinical trials, eight of whom were taking tegaserod, all on the highest dose of this drug. All eight developed symptoms and five underwent hospitalization and surgery (one placebo patient had polycystic ovarian disease that did not require surgery
  • [hide all summaries]
    This is the first study to document the presence of the 5-HT4 receptor in ovarian tissue. As a result, we now have a plausible biological mechanism for the development of the observed ovarian cysts that occurred in women and rats.
  • [hide all summaries]
    Letter/Comments-Regulatory by Elizabeth Barbehenn, Ph.D. Peter Lurie, M.D., M.P.H. Sidney Wolfe, M.D. Letter to the Food and Drug Administration urging that it not approve tegaserod (Zelmac) because of its highly questionable efficacy and its potential to cause ovarian cysts

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