NAPROXEN Linked to Cardiovascular Risk

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NAPROXEN Linked to Cardiovascular Risk
Authored by Stephanie McClain Riddle PharmD

New evidence suggests a greater incidence of cardiovascular risk in patients taking naproxen on a regular basis than those routinely taking ibuprofen. Cardiovascular risk is defined as a cardiovascular event leading to death, a nonfatal myocardial infarction, or nonfatal stroke.

Data collected from the Women’s Health Initiative Study provide evidence that routine use of over-the-counter naproxen products, such as Aleve®, and generic or house brands of naproxen, increase the risk of cardiovascular events. The data collected was compared to another over-the-counter product, ibuprofen, which was found to have a lower cardiovascular risk.


In February of this year, two FDA advisory panels rejected a proposal to change the labeling on naproxen products. The proposed change included a statement of reduced cardiovascular risk. As it turns out, the FDA advisory panels were right, supported by the recent data studied from the Women’s Health Initiative Study and published in the journal Circulation, Cardiovascular Quality and Outcomes.

The 2007 American Heart Association guidelines for the use of nonsteroidal anti-inflammatory drugs, commonly referred to as NSAIDs, recommended the use of naproxen as a good choice for the treatment of pain, joint, and musculoskeletal conditions in patient with heart conditions, or those at risk of heart problems. The recent published data may lead to changes in the American Heart Association guidelines.

The study data analysis discovered an overall 10% increase in the risk of cardiovascular death with regular nonsteroidal anti-inflammatory use in postmenopausal women. The drugs were further divided into three groups based on their mechanism of action. The first group included prescription drugs like Celebrex, Bextra, and Vioxx, known as COX-2 selective inhibitors. The risk of cardiovascular events was increased by 13% with this group of drugs. The second group included drugs such as naproxen and diclofenac. The cardiovascular risk was increased by 17% with this group. Data studied from the third group, drugs such as ibuprofen and ketoprofen, showed no elevation of cardiovascular risk with these agents.

The review of this data is ongoing, and will likely lead to more research before a clear consensus on recommended changes in therapy is reached. The primary message in the 2007 American Heart Association guidelines for the use of nonsteroidal anti-inflammatory drugs in patients with, or at risk for, cardiovascular disease, remains solid. Use the safest drug, use the lowest effective dose possible, and for the shortest possible time frame. Do not take them regularly, or chronically, unless your physician has advised you to do so. Also be cautious of combining the nonsteroidal anti-inflammatory group of drugs with aspirin products. Be aware, but do not make any changes in your prescribed medications without first consulting your physician.

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References for this article are available upon request.

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