FOR IMMEDIATE RELEASE On Naproxen And Aleve Side Effects
FDA Statement
Statement Dec. 20, 2004 Media Inquiries: 301-827-6242 Consumer Inquiries: 888-INFO-FDA
FDA Statement on Naproxen Aleve side effects 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 Aleve 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 Aleve.
In the meantime, FDA advises patients who are currently taking over-the-counter Naproxen Aleve products to carefully follow the instructions on the label. Patients should not exceed the recommended doses for Naproxen Aleve (220 milligrams twice daily) and should not take Naproxen Aleve for longer than ten days unless a physician directs otherwise. Patients with questions about Naproxen Aleve should consult their physicians.
Naproxen Aleve 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.