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Ponders Pain Relievers’ Heart Attack Risk
Joe Graedon, M.S. and Teresa Graedon, Ph.D.
A high-stakes drama unfolded at the Food and Drug Administration
recently, but very few people appreciated its significance. Naproxen, sold
over the counter as Aleve and by prescription as Anaprox and Naprosyn,
is a popular nonsteroidal anti-inflammatory drug (NSAID). It competes with
other NSAIDs, such as ibuprofen (Advil, Motrin, etc.), celecoxib (Celebrex),
diclofenac (Cataflam, Voltaren, etc.) and meloxicam (Mobic), to name just
It is estimated that 30 million Americans take an NSAID every day to ease the
discomfort of arthritis, bursitis, sprains, strains, headaches and other painful
conditions. Most people assume such drugs are safe. But in 2005, the FDA issued
a public health advisory: “NSAIDs may cause an increased risk of serious
cardiovascular thrombotic events [blood clots], myocardial infarction [heart
attack], and stroke, which can be fatal.”
The controversy that has been raging for years is whether naproxen should be
exempt from such a strict and scary warning. Some studies suggest that naproxen
might be less likely to cause heart attacks or other cardiovascular complications.
Epidemiologists at the FDA asked an expert committee to review the data and reconsider
After a two-day meeting, the committee voted down the idea that naproxen was
safer than other NSAIDs. A majority of the members determined that the evidence
Not surprisingly, Pfizer, the company that makes Celebrex and Advil, expressed
agreement with the committee’s decision. Had the experts decided that naproxen
was safer, Bayer, the maker of Aleve, would have had a big marketing advantage.
If anything, the FDA advisory panel voted to strengthen the overall warning for
prescription NSAIDs. Current labeling implies that the heart-attack risk only
applies to long-term use. The panel has suggested new wording to warn health
professionals that the increased risk of dangerous blood clots that could cause
heart attacks may start with the first dose. No changes were recommended for
OTC pain-reliever labels.
Sadly, many Americans don’t bother to read labels. Only about half of people
surveyed realized that NSAIDs can have serious side effects (Journal of Rheumatology,
What should you know about NSAIDs? While these medicines can be helpful in relieving
inflammation and pain, they do not address the underlying cause of the pain.
Side effects to be aware of, in addition to the risk of heart attack or stroke,
include severe irritation of the stomach or small intestine. In some cases this
can result in an ulcer. A bleeding ulcer is a life-threatening complication,
so people taking anticoagulants (especially warfarin) are usually advised to
Other serious complications include high blood pressure, fluid retention, headache,
dizziness, drowsiness, skin rash, heart failure, ringing in the ears, liver or
kidney damage, blood disorders and worsening asthma symptoms.
With such a long list, it is hardly any wonder that people look for alternatives.
Many find that home remedies work well without worrisome side effects. To learn
more about these options, you may wish to read our book “The People’s
Pharmacy Quick and Handy Home Remedies” (online at www.PeoplesPharmacy.com).
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