FDA has issued a public health advisory about Tegaserod to advise patients and their doctors that Novartis Pharmaceuticals Corporation will stop selling Zelnorm (Tegaserod).
Tegaserod is being taken off the market because safety analysis has shown a 10x 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 Tegaserod.
FDA announces the following, effective immediately:
- FDA?s request, Novartis Pharmaceuticals Corporation has agreed to stop selling Zelnorm.
- Patients being treated with Tegaserod should contact their physician to discuss alternative treatments for their condition.
- Patients who are taking Tegaserod 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 Tegaserod should work with their patients and transition them to other therapies as appropriate to their symptoms and need.
Tegaserod is a GI drug approved for short term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years with chronic constipation. In late February and early March 2007, Novartis Pharmaceuticals gave FDA the results of new analyses of 29 clinical studies of Tegaserod for treatment of a variety of gastrointestinal tract conditions; the data from all the studies were combined to assess the chance of side effects on the heart and blood vessels. In each study, patients were assigned at random to either Tegaserod or a sugar pill they thought was Tegaserod.
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