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.

• Patient Information Sheet

• Healthcare Professional Information

  • Healthcare Professional Information Sheet

  • Prescribing Information (label)

• Other Information

  • FDA Issues Public Health Advisory Recommending Limited Use of Cox-2 Inhibitors.  FDA Talk Paper (12/23/2004)

  • Public Health Advisory: Non-Steroidal Anti-Inflammatory Drug Products (NSAIDS) (12/23/2004)

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Date created: December 23, 2004, Updated January 10, 2005

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