FDA Makes Statement on Naproxen (Aleve)

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FDA Statement on Naproxen

The FDA today released the following statement on NIH halting a clinical trial involving non-steroidal anti-inflammatory drugs in patients at risk of developing Alzheimer's Disease:

The Food and Drug Administration (FDA) is working with the National Institutes of Health to review 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.

In the meantime, 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. Patients with questions about naproxen should consult their physicians.

Naproxen was first sold as a prescription drug under the trade name Naprosyn in 1976. FDA approved its use as an over-the-counter drug in 1994.

Source: FDA Statement, December 20, 2004