On March 30, 2007 the FDA notified healthcare professionals and patients that Novartis has agreed to discontinue marketing Zelnorm, a drug used for the short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years of age with chronic constipation. FDA analysis of safety data pooled from 29 clinical trials involving over 18,000 patients showed an excess number of serious cardiovascular adverse events, including angina, heart attacks, and stroke, in patients taking Zelnorm compared to patients given placebo. Patients taking Zelnorm should contact their healthcare professional to discuss treatment alternatives and seek emergency medical care if they experience severe chest pain, shortness of breath, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke. Healthcare professionals should assess their patients and transition them to other therapies as appropriate
Zelnorm Has Serious Side Effects
Zelnorm (tegaserod) is a prescription drug for the short-term treatment of women with irritable bowel syndrome (IBS). Zelnorm is intended primarily to treat the constipation that accompanies IBS. (It has never been tested in men.)
Summary: The FDA has added new warning information to the label of the drug Zelnorm. Patients are warned to stop taking Zelnorm immediately if they develop rectal bleeding, bloody diarrhea, or new or worsening abdominal pain. These are symptoms of intestinal ischemia in which the supply of blood and oxygen to the intestines are compromised. Zelnorm rarely causes severe diarrhea that can result in dehydration and a need for intravenous fluids. Therefore, Zelnorm also should be stopped if diarrhea occurs.
FDA Public Health Advisory
FDA is issuing this public health advisory to inform patients and health care professionals that the sponsor of Zelnorm (tegaserod maleate), Novartis Pharmaceuticals Corporation, has agreed to stop selling Zelnorm. Zelnorm is being taken off the market because a new safety analysis has found a higher chance of heart attack, stroke, and worsening heart chest pain that can become a heart attack in patients treated with Zelnorm compared to those treated with a sugar pill they thought was Zelnorm.
FDA announces the following, effective immediately:
- At FDA's request, Novartis Pharmaceuticals Corporation has agreed to stop selling Zelnorm.
- Patients being treated with Zelnorm should contact their physician to discuss alternative treatments for their condition.
- Patients who are taking Zelnorm should 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.
- Physicians who prescribe Zelnorm should work with their patients and transition them to other therapies as appropriate to their symptoms and need.