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On December 20, 2004 the Food and Drug Administration issued a public naproxen warning about the possible dangers of suffering heart attack or stroke as a result of naproxen use. This naproxen warning comes less than a week after federal regulators issued a public warning statement about the possible cardiovascular risks associated with Celebrex. On September 30, 2004 Vioxx was recalled because clinical evidence concluded that this drug doubled a patient’s risk of suffering a serious heart attack or stroke.

What each of these Vioxx, Celebrex, and Naproxen warning statements have in common is that each of these medications are non-steroidal anti-inflammatory drugs (NSAIDs) used to treat the severe pain associated with arthritis, menstrual cramps, and other health conditions. Vioxx and Celebrex are COX-2 selective pain medications and naproxen is a non-selective NSAID. Vioxx and Celebrex were developed in part because naproxen warning statements have long revealed that naproxen use carries the risk of serious gastrointestinal complications. Cardiovascular complications have been a recent subject of scrutiny for COX-2 selective drugs, though this recent naproxen warning is raising questions about the safety of all NSAIDs.

This cardiovascular safety naproxen warning is the first of its kind since this drug first hit the US market in 1976. Naproxen is a pain medication that is available in both prescription and non-prescription (over-the-counter) strengths. Common naproxen warning statements have long included side effects such as gastrointestinal complications, photosensitivity, headache, and edema. Naproxen warning contraindications caution patients with a history of heart disease, liver and kidney problems, coagulation (blood clotting) conditions, high blood pressure, and people with allergic reactions to similar medications.

The naproxen warning about cardiovascular risks comes out of preliminary findings in an Alzheimer prevention study. In 2001 the National Institutes of Health began a three year trial called ADAPT with 2,500 participants over the age of seventy. Of these trial participants, some were taking naproxen, some were taking Celebrex, and another group was taking a placebo or sugar pill. The naproxen warning revealed that patients in the naproxen group had a fifty percent increase of suffering adverse cardiovascular complications than the placebo group. Regulators, researchers, and pharmaceutical companies are currently looking into the implications of this naproxen warning and all regulatory options are being considered, according to FDA officials.

The statistical significance of this naproxen warning is still unclear, though strong efforts are being made to determine the cardiovascular risks associated with naproxen use. If you or a loved one is taking naproxen and experience any symptoms of a heart attack or stroke, it is important to seek medical attention immediately. Of you are concerned about the recent naproxen warning you may also wish to contact your physician or other health care provider in order to address these apprehensions.

"FDA issues new drug warning statement on naproxen (Aleve)"

The FDA says it is working with the National Institutes of Health to review available scientific information on naproxen, sold under the brand name Aleve by Bayer, after the decision to halt a clinical trial studying the effect of naproxen on patients...

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