FDA is announcing that Novartis Pharmaceuticals has agreed to FDA’s request that they voluntarily discontinue marketing and sales of Zelnorm (tegaserod maleate). FDA’s request was based on newly available information of an increased risk of serious cardiovascular adverse events, including myocardial infarction (heart attack), unstable angina (chest pain), and stroke, associated with use of the drug. Based on this new information, FDA has concluded that the overall risk versus benefit profile for the drug is unfavorable for continued marketing.
Source: U.S. Food and Drug Administration
Zelnorm (tegaserod maleate) update information
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