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(H1) Zelnorm Irritable Bowel Syndrome (IBS) Treatment Causing Ischemic Colitis

Zelnorm has been observed to be linked to ischemic colitis, severe diarrhea, and potential for death in some patients. The FDA has ordered a labeling precaution about the intestinal condition about Zelnorm, along with an order to place larger warnings about severe diarrhea on Zelnorm labels. Zelnorm is used to help movement of stool through the colon.

Twenty-one reports to the FDA of severe diarrhea causing low blood pressure and fainting as side effects. Sixteen Zelnorm patients were reported to have required immediate hospitalization. The FDA received 20 reports of ischemic colitis and three concerning similar intestinal problems. Four patients died and fourteen needed hospitalization.

The FDA has warned that Zelnorm should be discontinued by anyone with frequent diarrhea, and those experiencing dizziness or fainting should stop the drug immediately.

Irritable bowel syndrome (IBS) is an intestinal disorder that gives millions of women and some men, abdominal pain, severe diarrhea, constipation, sometimes both. Zelnorm is the only FDA-approved therapy for the constipation-causing form of IBS. It is usually prescribed only for women.