Tegaserod maleate (marketed as Zelnorm) - Overview
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Welcome to the Food and Drug Administration's drug safety update. I am Pat Clarke from F D A's Center for Drug Evaluation and Research.
On March 30, 2007, we issued a public health advisory about the voluntary Market Withdrawal of Zelnorm, a drug used for short-term treatment of women with irritable bowel syndrome with constipation and patients younger than 65-years-of-age with chronic constipation. The drug is also known by its generic name tegaserod [te-gas-a-rod] maleate.
Novartis Pharmaceuticals Corporation, the manufacturer of Zelnorm, has agreed to withdraw this drug from the market due to the potential for heart attack, stroke or worsening heart chest pain that can turn ino a heart attack.
FDA is recommending that patients who are taking Zelnorm should discuss with their health care professionals other treatments for irritable bowel syndrome and chronic constipation.
To hear the full public health advisory, listen to Part 2 of this broadcast.
We are asking health-care professionals to report serious adverse events in connection with Zelnorm to us through the MedWatch program by phone at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot gov slash MedWatch.