Novartis Stops Drug Marketing Amid Safety Concerns

Law360, New York (March 30, 2007, 12:00 AM EDT) -- Nudged by the U.S. Food and Drug Administration, Switzerland’s Novartis on Friday agreed to stop marketing the drug Zelnorm amid concerns the drug could trigger serious heart problems.

The FDA asked Novartis to pull its marketing after the drug maker submitted a research study showing that the risk of serious cardiovascular adverse events such as heart attacks and strokes are associated with use of Zelnorm is higher than with placebo treatment.

In an analysis of 11,600 patients treated with Zelnorm and over 7000 patients treated with...
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