Zelnorm is the trade name for tegaserod, a 5-HT4 agonist used for the management of irritable bowel syndrome (IBS) and constipation. In 2002 the U. S. Food and Drug Administration approved Zelnorm for short-term treatment of women with irritable bowel syndrome. The pharmaceutical company Novartis marketed the prescription drug under the trade names Zelnorm in the U. S. or Zelmac in other countries. Novartis amended its Zelnorm label in March 2004 to warn against the serious risk of diarrhea, ischemic colitis and death. In August 2004, the FDA further approved the prescription drug for men and women younger than 65 years of age with chronic constipation.
The FDA advised patients taking Zelnorm to seek emergency medical care right away if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking or other symptoms of a heart attack or stroke.
Newly released clinical trial data confirmed an increased risk of serious adverse cardiovascular events, including chest pain, heart attack, and stroke related with the use of Zelnorm. Based on the recent data, the FDA requested Novartis remove Zelnorm from the market and issued a drug recall on March 30, 2007.
FDA Questions and Answers on Zelnorm
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