Naproxen & the Heart: The Jury’s Still Out

By Nadine Salmon, MSN, BSN, IBCLC, Clinical Content Manager AMN Healthcare

Naproxen & the Heart: The Jury’s Still OutJust as the country celebrates American Heart Month, the FDA released a memo at the beginning of February promoting the use of naproxen sodium (Aleve) over other non-steroidal anti-inflammatory drugs (NSAIDs), such as Motrin and Advil. However, the FDA’s Advisory Panel met again a few weeks later to revise their recommendation. The advisory panel voted 16-9 against the assumption that naproxen has a lower risk of heart attack and stroke than similar anti-inflammatory medications, and cited a lack of conclusive evidence that the drug is safe for the heart.

Every day, more than 30 million people take over-the-counter and prescription NSAIDs for pain relief, headaches and arthritis (Science Daily, 2005). Millions of Americans use NSAIDs for analgesic, antipyretic and anti-inflammatory effects. The most common NSAIDs are aspirin, ibuprofen (Motrin and Advil) and naproxen (Aleve).

Aleve, produced by the pharmaceutical company Bayer LLC., is believed by some to pose a lower cardiovascular (CV) risk than other NSAIDs. Naproxen sodium, the active ingredient in Aleve, may have a lower risk of heart attack and stroke than ibuprofen, but to date, there is no conclusive evidence to support this supposition. The FDA had initially recommended relabeling naproxen to emphasize its safety, yet the decision was reversed after 16 panel members opposed the recommendation.

The safety review was initially prompted by a large study published last year that analyzed 350,000 patients who took various pain relievers. The findings suggested that naproxen does not carry the same cardiac risks as other NSAIDs (Perrone, 2014).

The FDA memo precedes a public meeting scheduled for March 2014, where outside experts will discuss the findings and determine whether or not naproxen should be relabeled. Current labeling warns that taking NSAIDs long-term can increase the risk of heart attack and stroke. Patients are advised to take the drugs for the shortest time period possible If the relabeling of naproxen sodium does take place, this could result in an explosion in sales for Bayer, and provide a competitive edge for them over rival pharmaceutical companies offering other NSAIDs.

In 2004, Vioxx, a newer subset of NSAIDS, was pulled from the market due to concern about its potential to increase the risk of heart attack and stroke. Following this recall, the FDA increased its warnings about heart safety risks on all drugs in the class, including Motrin, Advil, Aleve and Celebrex (Perrone, 2014). Today, Pfizer's Celebrex is the only drug from the same class as Vioxx that remains on the market. Celebrex is available by prescription only.

The FDA has also disclosed that it is considering halting a long-term study comparing the safety of naproxen, ibuprofen and Celebrex, as naproxen has already been shown to be safer for the heart than similar drugs, and the FDA does not want to expose trial participants to any further possible risk.

While naproxen sodium is a relatively safe drug, there are many other medications that may present high risk to patients. To learn more about these medications and safe administration, check out High Alert Medications: Safe Practices at RN.com.


  1. Federal Drug Administration [FDA]. (2014). Aleve (naproxen sodium) & Naprosyn (naproxen): Briefing Document for U.S. Food and Drug Administration Advisory Committee Meeting. Retrieved from http://www.fda.gov/downloads/advisorycommittees/ committeesmeetingmaterials/drugs/arthritisadvisorycommittee/ucm383181.pdf
  2. Fox News (2014). FDA panel votes down heart safety claim for Aleve. Retrieved from http://www.foxnews.com/health/2014/02/11/fda-panel-says-data-does-not-support-lower-heart-risk-aleve/
  3. Perrone, M. (2014). FDA: Aleve may be safer on heart than rival drugs. The Associated Press, Jan 28, 2014. Retrieved from http://start.toshiba.com/news/read/category/Top%20News/article/ap-fda_aleve_may_be_safer_on_heart_than_riv-ap
  4. ScienceDaily. (2005). Study Shows Long-term Use Of NSAIDs Causes Severe Intestinal Damage. Retrieved from http://www.sciencedaily.com/releases/2005/01/050111123706.htm


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