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U.S. Department of Health and Human Services

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Naproxen Information

FDA Alert:  Based on emerging information from a long-term prevention trial, the risk of cardiovascular and cerebrovascular events may increase among patients taking naproxen. FDA will be analyzing all available information from these studies to determine whether additional regulatory action is needed.

 

1/10/2005

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Labeling and Regulatory History from Drugs@FDA

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