April 2, 2007
 
Medical Monday: FDA Says Makers of Zelnorm Will Stop Marketing Drug in U.S.
 
By Craig Hammond
 
The Food and Drug Administration (FDA) announced Friday March 30, 2007 that Novartis Pharmaceuticals Corp. of East Hanover, New Jersey will suspend marketing of the drug Zelnorm (tegaserod) in the United States based on findings of an increased risk of serious cardiovascular adverse events (such as angina, heart attacks, and strokes) associated with use of the drug.
 
Zelnorm is a prescription medicine approved in July 2002 for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation. It was subsequently approved in August 2004 for treatment of chronic constipation for men and women under age 65. Zelnorm is marketed in 55 countries.
 
For the last few months Novartis reported to the FDA results of 29 short-term (1 - 3 months) randomized, controlled clinical trials of Zelnorm. The FDA has concluded, based on this data, that for most patients the benefits of this drug no longer outweigh the risks.
 
The FDA actually requested that the company voluntarily discontinue marketing the drug. Novartis immediately agreed to do so. However, the FDA will work with Novartis to allow access to Zelnorm as an investigational drug for patients with no other treatment options and where the benefits may outweigh the risks.
 
This action is a good example of the FDA's constant monitoring of approved drugs and Novartis Pharmaceuticals Corporation compliance with FDA requirments of clinical testing and self-reporting. This quick action of the FDA and Novartis shows how our system is working -- and working well -- for our safety.