Zelnorm

Zelnorm Linked to Increased Risk of Heart Attack and Stroke

March 30, 2007 – the Food and Drug Administration (FDA) issued a public health advisory to inform the public that Zelnorm is being taken off the market because it has been found to increase the risk of heart attack, stroke, and worsening heart chest pain. 

Zelnorm is a prescription drug approved for short term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years with chronic constipation.  

Safety data from 29 clinical trials involving over 18,000 patients showed that cardiovascular ischemic events occurred in 13 out of 11,614 patients treated with Zelnorm (0.11%), compared with one case in 7,031(0.01%) patients treated with a sugar pill they thought was Zelnorm. All patients affected had pre-existing cardiovascular disease and/or cardiovascular risk factors.

The sponsor of Zelnorm (tegaserod maleate), Novartis Pharmaceuticals Corporation, has agreed to stop selling Zelnorm. 

In its Public Health Advisory, the FDA made the following announcements, effective immediately: 

• 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. 
  

Do not change medication without consulting your doctor.

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