It took until February and March 2007 for Novartis to report to FDA the results of randomized, controlled clinical trials of Zelnorm that showed that for most patients the benefits of this drug no longer outweigh the risks. Why was this not discovered and told the the FDA in 2002 or 2004 when the drug was approved? Why weren't these studies performed by Novartis sooner than they were?
The recent analysis included over 11,600 patients who treated with Zelnorm. Those results were compared to 7000+ patients who treated with a placebo.
Shocking Results! The studies showed a serious risk of dangerous cardiovascular events including angina, heart attacks, and strokes. Zelnorm now shows a high risk compared to placebo treatment. The risk appears to be a 10x increase for heart attack or other cardiovascular injury.
FDA Actions: Now the FDA is working to limit the use of Zelnorm. It may only end up as an "investigational drug" for patients with no other treatment options where the benefits may outweigh the risks. This makes the market for Zelnorm much smaller, where the drug could be given to a population of patients in which the benefits of the drug outweigh the risks. In order for this to occur, a public advisory committee meeting would take place.
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