A high-stakes drama unfolded at the FDA 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 a few.

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 the labeling.

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 is inconclusive.

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, Nov. 2005).

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 avoid NSAIDs.

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 & Handy Home Remedies (online at PeoplesPharmacy.com).

 

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  1. Sue
    Reply

    What is considered long term use of Naproxen?? I can’t find this info anywhere!!!!!

  2. Kahleen
    Reply

    very interesting info…

  3. SEJ
    Reply

    I was switched to Meloxicam 7.5mg (Mobic) for arthritis after Vioxx was taken off the market, so I’ve been on NSAIDS forever. So far, I’ve suffered no ill effects, but plan to speak to my Dr. about it with all the new research.

  4. NWG
    Reply

    Is Voltaren Gel as harmful as the Voltaren pills? I use the gel to rub on different areas where my arthritis is acting up.

  5. AMR
    Reply

    My husband suffered from pulmonary emboli caused by a deep vein thrombosis in his leg while on Meloxicam (7.5 mg) for arthritis. While he was in the hospital critical care unit, one nurse brought Meloxicam in for him to take. I stopped her, and found out the next day that he was not supposed to be getting that drug while in the hospital. I have found it curious that in the four months since his PE that no MD has mentioned Meloxicam or has even been interested in talking about it if I have brought up the subject. Is DVT after taking Meloxicam for 6 weeks something that should be reported to the FDA?

  6. WJR
    Reply

    You quote the FDA saying “NSAIDs may cause an increased risk of serious cardiovascular thrombotic events [blood clots], myocardial infarction [heart attack], and stroke, which can be fatal” with no comment on the common practice of taking a baby aspirin every day! Is this now a health exposure rather than a benefit? I’ve been taking baby aspirin for decades…
    People’s Pharmacy response: Aspirin is different from other NSAIDs and actually helps protect the heart.

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