Zelnorm Associated With Rare Cases of Severe Diarrhea, Ischemic Colitis

Yael Waknine

Disclosures

April 29, 2004

April 29, 2004 — The U.S. Food and Drug Administration (FDA) and Novartis notified healthcare professionals on April 26 of revisions to the warnings and precautions sections of labeling for tegaserod maleate (Zelnorm). The warning refers to serious consequences of diarrhea (including hypovolemia, hypotension, and syncope) that occurred both during clinical trials and during marketed use, in some cases requiring hospitalization.

Tegaserod maleate is a serotonin 5-HT4 receptor partial agonist, indicated for the short-term treatment of women with irritable bowel syndrome whose primary bowel symptom is constipation.

According to the FDA, tegaserod maleate should be discontinued in patients who develop hypotension or syncope. It should not be initiated in patients who frequently experience or are currently experiencing diarrhea.

The precaution refers to rare cases of ischemic colitis and other forms of intestinal ischemia that have been reported during marketed use of tegaserod maleate, although no causal relationship has been established.

The FDA recommends discontinuation of the drug in patients who develop symptoms of ischemic colitis such as rectal bleeding, bloody diarrhea, or new/worsening abdominal pain. These patients should be evaluated promptly and treatment with tegaserod maleate should not be resumed if a diagnosis of ischemic colitis is confirmed.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of tegaserod maleate to Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936, or call 1-888-669-6682, or via the Internet at http://www.novartis.com.

Alternatively, this information may be reported to the FDA's MedWatch safety information and adverse event reporting program by calling 1-800-FDA-1088, by fax at 1-800-FDA-0178, or via the Internet using Form 3500 at http://www.fda.gov/medwatch/index.html.

Reviewed by Gary D. Vogin, MD

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