Naproxen - FDA Statement on halting of NIH clinical trial

  1. MedWatch - The FDA Safety Information and Adverse Event Reporting Program

    FDA announced that it was reviewing the available scientific information on
    naproxen following the decision of the National Institute on Aging to halt a
    clinical trial studying non-steroidal anti-inflammatory drugs in patients at
    risk of developing Alzheimer's disease. Preliminary information from the
    study showed some evidence of increased risk of cardiovascular events, when
    compared to placebo, to patients taking naproxen. FDA advises patients who
    are currently taking over-the-counter naproxen products to carefully follow
    the instructions on the label. Patients should not exceed the recommended
    doses for naproxen (220 milligrams twice daily) and should not take naproxen
    for longer than ten days unless a physician directs otherwise.

    Read the MedWatch 2004 safety summary, including a link to the FDA Statement
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