|Volume 6 Issue 357 Published - 14:00 UTC 08:00 EST 22-Dec-2004 Next Update - 14:00 UTC 08:00 EST 23-Dec-2004||Editor: Susan K. Boyer, RN
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FDA & NIH statements on naproxen (Aleve®)
On 20 December 2004, the FDA 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.
Use of Non-Steroidal Anti-Inflammatory Drugs Suspended in Large Alzheimer's Disease Prevention Trial
On 20 December 2004, the National Institutes of Health (NIH) announced that research investigators suspended, until further notice, the use of two drugs, naproxen (220 mg twice a day) and celecoxib (200 mg twice a day), in a large, three-arm, national Alzheimer’s disease prevention trial sponsored by the National Institute on Aging (NIA), a part of the NIH. The trial, called the Alzheimer’s Disease Anti-Inflammatory Prevention Trial (or ADAPT) was designed to assess the potential benefit of long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) naproxen (Aleve™) and the COX-2 inhibitor celecoxib (Celebrex™ ) in decreasing the risk of developing Alzheimer’s Disease in people 70 years of age or older who were considered to be at increased risk because of family history, but did not have symptoms of the disease.
Approximately 2400 volunteer participants were randomly assigned to receive naproxen, celecoxib, or placebo for periods of time up to three years. Although no significant increase in risk for celecoxib was found in this trial, the use of these drugs in the study was suspended in part because of findings reported last week from a National Cancer Institute (NCI) trial to test the effectiveness of celecoxib in preventing colon cancer. In addition, however, data from the ADAPT trial indicated an apparent increase in cardiovascular and cerebrovascular events among the participants taking naproxen when compared with those on placebo.
“This step is being taken as a precautionary measure to ensure the safety of the study’s participants,” said NIH Director, Elias A. Zerhouni, M.D. “The investigators made their decision based on the risk/benefit analysis specific to this trial,” added Dr. Zerhouni.
The ADAPT trial began in 2001 and was conducted at six sites across the U.S. Tampa, FL; Rochester, NY; Baltimore, MD; Sun City, AZ; Seattle, WA; and, Boston, MA. The principal investigator for the study is John Breitner, M.D., of the Veterans Affairs Medical Center Puget Sound and the University of Washington.
Investigators and NIH scientists will continue to review this and other NSAIDs studies sponsored by NIH in the light of these findings. It should be pointed that the cancer prevention trials and the ADAPT study are among the first long-term, clinical trials to test these classes of drugs. These studies are examining these compounds for uses very different from the uses for which these medications are currently approved. NIH and FDA will work together to provide the public with information they need to make informed health decisions.
Information for the public and health professionals will be posted at www.nih.gov as soon as additional data become available.