FDA: Naproxen Not Safer Than Other NSAIDs

Aleve1All non-steroidal anti-inflammatory drugs (NSAIDs), including popular over-the-counter drugs like Advil and Motrin, carry a warning that they increase the risk for heart attack and stroke. Last year, a large meta-analysis published in the Lancet concluded that one NSAID, naproxen, was safer:

Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials, Lancet, August 2013

Last Tuesday, an FDA Advisory Panel contradicted that:*

“… available evidence does not prove that the painkiller naproxen, sold under the brand names Aleve and Naprosyn, carries a lower cardiac risk than rival products.”

The panel was tasked with weighing the evidence on just naproxen. But the heart and stroke risk associated with the whole NSAID class keeps rearing its head, ever since the Vioxx fiasco in 2004. From Medscape:

“A slight majority of the AAC and DSARM panel members also felt the weight of clinical evidence supported a reconsideration of the current NSAID labeling. The label implies that cardiovascular thrombotic risk is not “substantial” with short treatment courses, but 14 panel members said this advice should be reconsidered and that there was no latency period with the NSAID class. Eleven panel members did not feel the label needed to be changed, although many of those who voted against the label change said they didn’t feel there was any period in which the cardiovascular risks were nonexistent.”

Finally, the panel also discussed whether or not changes should be made to the label of over-the-counter NSAIDs at currently available doses, to refine the message about cardiovascular risk, but this was a nonvoting question. No consensus was reached given the absence of data.”

So they want to make the warning more obvious. They should, because it’s unfortunately not common knowledge that Advil, Aleve, Motrin, Celebrex, etc. all increase the risk for heart attack. The bottle of Advil I’m holding has the warning blended in using the same text as “Uses” and “Directions.”

From the sounds of the FDA Advisory Panel (“no latency period”), not only do NSAIDS as a class increase the risk for heart attack and stroke, but the amount of drug needed to elicit such an event may be very small, especially for someone with established cardiovascular problems, high cholesterol, high blood pressure, diabetes, etc. So much for moderation.

What to do for pain relief?  Dr. Marie Griffin from Vanderbilt, said:

“Patients should be offered evidence-based nonpharmacological treatments, including application of heat or cold, exercise, weight-loss or self-management programs.”

Many people use NSAIDs for arthritic pain. One very powerful non-drug treatment for arthritis is diet. In “Diet: Only Hope For Arthritis,” Dr. McDougall writes:

“Arthritis is not a genetic disease, nor is it an inevitable part of growing older – there are causes for these joint afflictions, and they lie in our environment – our closest contact with our environment is our food.

These once unknown joint diseases are now becoming common as people … abandon their traditional diets of grains and vegetables for meat, dairy products, and highly processed foods.”

McDougall’s advice? Eat a whole food, plant-based diet low in fat and devoid of animal products. (Effects of a Very Low-Fat, Vegan Diet in Subjects with Rheumatoid Arthritis, McDougall et al., 2002)

Update:  Here’s Dr. McDougall’s diet for arthritis in a bit more detail.

* See also:
FDA Panel Says Data Does Not Support Lower Heart Risk Of Naproxen, Reuters, 11 February 2014
FDA Advisory Panels Against CV Safety Claim for Naproxen, Medscape/Heartwire, 11 February 2014
Panel Votes Down Heart Safety Claim for Naproxen, Associated Press, 11 February 2014

One thought on “FDA: Naproxen Not Safer Than Other NSAIDs

  1. Pingback: New Study: Ibuprofen (Advil) Shown To Extend Life | Fanatic Cook

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