March 2007 had the U. S Food and Drug Administration asking Novartis Pharmaceuticals to voluntarily discontinue marketing of Zelnorm (tegaserod). The request comes on the heels of the recently identified finding of serious cardiovascular adverse events, hear problems, associated with the use of the drug. Novartis has voluntarily agreed to comply and suspend marketing in the U.S.
Zelnorm, approved in 2002, as a short term treatment for women with irritable bowel syndrome with the primary symptom of constipation and approved for chronic constipation in 2004.
"This decision reflects the FDA's commitment to continuously monitor approved drugs throughout their marketing life, and take action when we believe the risks exceed the benefits," said Dr. Douglas Throckmorton, Deputy Director for the Center for Drug Evaluation and Research. "Here, a potential risk of very serious harm to patients who have this non-life-threatening condition was recently identified, making this action necessary."
The FDA will work with Novartis to establish the possibility of Zelnorm being used on patients that have no other options and where the benefits may outweigh the associated risks.
[Source: FDA]
» Drug Warnings and Withdrawls for 2007 from PharmaGazette
FiercePharma has compiled a list of the top 10 drugs to have who have had approval either withdrawn or been forced to add stronger warning labels, by the FDA, with respect to their pharmaceutical products. The list is based on 2006 worl... [Read More]
Tracked on: December 5, 2007 2:41 PM | Permalink to Trackback