Novartis Pharmaceuticals Corp. has changed the professional labeling of Zelnorm (tegaserod maleate) to include new warnings about diarrhea, ischemic colitis, and adverse events.
The drug is used for the short-term treatment of women with irritable bowel syndrome whose primary bowel symptom is constipation.
The new diarrhea warning states "Zelnorm should be discontinued immediately in patients who develop hypotension or syncope. Zelnorm should not be initiated in patients who are currently experiencing or frequently experience diarrhea."
The new ischemic colitis warning says, "Ischemic colitis, and other forms of intestinal ischemia, have been reported in patients receiving Zelnorm during marketed use ... Zelnorm should be discontinued immediately in patients who develop symptoms of ischemic colitis, such as rectal bleeding, bloody diarrhea or new or worsening abdominal pain. Treatment with Zelnorm should not be resumed in patients who develop findings consistent with ischemic colitis."
New labeling under the adverse events section states: "Voluntary reports of adverse events occurring with the use of Zelnorm include the following: ischemic colitis, mesenteric ischemia, gangrenous bowel, rectal bleeding, syncope, suspected sphincter of Oddi spasm, bile duct stone, and cholecystitis with elevated transaminases."
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