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.
