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FDA warns naproxen (Aleve) users

–December 21, 2004

NSAIDS, or nonsteroidal anti-inflammatory drugs, are used to treat a variety of ailments, including headaches, menstrual cramps, arthritis and gout. A popular NSAID called naproxen is sold under the brand name Aleve and is manufactured by Bayer. A subset of NSAIDs, Cox-2 inhibitors, have been amidst controversy following the largest prescription drug recall of all time - Merck & Co.'s September 30 Vioxx recall - and the December 17 Pfizer Inc. announcement that a study linked Celebrex to increased risks of heart attacks.

Just as Pfizer announced Monday, December 20 that it was discontinuing all advertising for Celebrex in response to an FDA request, federal health officials raised questions about the potential for similar problems with naproxen (Aleve). The FDA's Office of New Drugs deputy director, Dr. Sandra Kweder, described the new Aleve information as being "a very confusing situation."

The Aleve safety concerns were in response to preliminary findings from a study by the National Institute on Aging. Trying to determine if naproxen could help reduce the risk of developing Alzheimer's disease, patients taking Aleve were found to have about a 50 percent greater chance of suffering strokes or heart attacks than those taking a placebo, according to Dr. John Breitner, the study's principal investigator.

The study began in 2001 and followed about 2,400 volunteers ages 70 and older who were considered at risk of developing Alzheimer's because of family history. In addition to trying to determine naproxen's influence on Alzheimer's risk, the trial sought to test whether Celebrex could help prevent the onset of Alzheimer's as well. Trial patients were divided into three groups - some taking a placebo, some taking Aleve and some taking Celebrex.

Strangely, no increased risk of heart problems were found among Celebrex patients, but a separate federal study on cancer prevention found a strong indicator of heart risk among patients taking high doses of Celebrex, which prompted the December 17 Celebrex heart risk announcement. Breitner said researchers decided to stop giving Celebrex to the patients in the Alzheimer's study in response to the announcement. After signs of possible problems with Aleve, investigators decided they could not continue to administer that drug without resolving questions either.

Breitner said the decision to suspend both treatments was because naproxen appeared to be giving a more negative signal, adding the cancer study's findings on Celebrex were stronger than the Alzheimer's study data on Aleve. According to some experts, rare drug side effects are not even observed in studies of several thousand patients.

The naproxen safety developments could expand questions about the entire class of NSAID medications, not just for Cox-2 inhibitors. NSAIDs also include popular ibuprofens sold under brand names Advil and Motrin. Even before the Celebrex announcement was made, the FDA was planning on holding a February 2005 meeting to discuss the safety concerns of Cox-2 inhibitors because of the Vioxx recall. Breitner says the opportunity to further study naproxen has so far not presented itself so he has more questions about the safety of NSAIDs than he has answers.

The FDA has recommended patients contact their doctors if using naproxen and avoid taking the drug for longer than 10 days.

For more information on naproxen and aleve side effects, please contact us to confer with a Naproxen Lawyer and learn your legal rights and options.


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