April 26, 2007
Zelnorm, IBS Drug Taken Off the Market
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.