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FDA Issues Caution About Aleve®

Aleve® May Increase Heart Problems, According to Recent Study

WASHINGTON, DC -- December 23, 2004 -- Patients taking the common painkiller naproxen or Aleve®, may have an increased risk of heart problems, according to a study cited by the Food and Drug Administration (FDA). A total of 2,500 seniors took part in a clinical trial to find out whether naproxen could prevent or slow the onset of Alzheimer's disease. However, those who took the drug had about twice the risk of having heart attacks or strokes compared to those who took fake pills or placebos. The National Institutes of Health halted the study because of safety concerns.

Naproxen is used to reduce the pain, swelling, and stiffness caused by gout and arthritis, to help relieve menstrual cramps, and to reduce pain after surgery. Many people also take naproxen for colds, flu, headaches, and minor muscle pain. It is available by prescription as well as over-the-counter under the brand name Aleve®.

Naproxen is a nonsteroidal anti-inflammatory drug or NSAID. This large class of drugs includes common, traditional medicines such as ibuprofen (Motrin® and Advil®), and aspirin. It also includes the newer COX-2 inhibitors--Celebrex® (celecoxib), Vioxx® (rofecoxib), and Bextra® (valdecoxib). Vioxx® was withdrawn from the market in September because it increases the risk of heart attacks and strokes. Bextra® has been linked to further heart ailments in patients who have undergone heart bypass operations.

FDA Guidance on Celebrex® and Aleve® or Naproxen

Last week, the FDA warned that Celebrex® may increase the risk of heart attacks, strokes, and heart-related deaths. The alert was based on a study of 2,000 patients with colorectal cancer. Those patients who took Celebrex® had a much greater chance of developing serious heart conditions than did those who received placebos.

In the Alzheimer's disease clinical trial, some seniors took Celebrex® rather than naproxen, and did not develop heart problems. Nevertheless, based on the colorectal cancer study and other evidence, the FDA warning about Celebrex® still stands. As for naproxen, the agency advises patients who are currently using the drug to follow the instructions on the label carefully and to take no more than the recommended doses of 220 milligrams twice daily. It also suggests that patients use naproxen for no longer than 10 days, unless directed to do so by their doctors.

The leader of the Alzheimer's study, Dr. John Breitner, stressed that its results are preliminary and said that more detailed data about naproxen's effects would not be released for publication for several months (Boston Globe, December 22, 2004). He also warned that other NSAIDs may prove no safer than naproxen in terms of heart attack and stroke risk (Medscape Medical News, December 21, 2004).

At Brayton Purcell, we are concerned about the harm caused by unsafe medications. We are currently reviewing cases involving arthritis drug users who have suffered from heart attacks, blood clots, and strokes. If you or a loved one has had these conditions while taking Bextra® or Celebrex® or after discontinuing either medication, please contact us to learn about your legal choices.

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