After a string of reports linking several anti-inflammatory drugs to heart attack and stroke, another has been added to the list: the popular over-the-counter painkiller Aleve (search).
What is Aleve?
Aleve (generic naproxen) is an NSAID — a nonsteroidal anti-inflammatory drug (search). “Nonsteroidal” refers to the fact that it is not a corticosteroid (search), like prednisone (search), which are strong anti-inflammatory drugs.
Older NSAIDs include aspirin, ibuprofen, and naproxen (search). Newer generations of NSAIDs are called Cox-2 inhibitors (search), such as Celebrex (search), Bextra (search), and Vioxx (search). Cox-2 inhibitors work a little differently than the older NSAIDs.
Is Aleve the only drug included in this new warning?
Aleve is the medication that was being used in the study that was halted. However, the FDA says the warning pertains to all drugs that contain the active ingredient naproxen. Other brand names of naproxen include Anaprox (search), Naprelan (search), and Naprosyn (search).
Which NSAIDs have been linked to heart attack and stroke?
Increasing evidence has linked Cox-2 inhibitors to heart attacks and strokes. In September, the Cox-2 inhibitor Vioxx was removed from the market. Vioxx was shown to increase the risk of heart attack and stroke after taking it for at least 18 months. Next, the FDA put out a warning about another Cox-2 inhibitor, Bextra, which was found to increase heart problems in people taking the drug after heart bypass surgery. Then, a study showed Celebrex to be linked to an increase in heart attack and stroke. This was seen in people taking high doses of Celebrex — 400 mg a day.
Most recently, the FDA and the National Institutes of Health put out a warning about Aleve. A large trial was stopped after Aleve was found to increase the risk of heart attacks and strokes by 50 percent. The FDA is recommending that patients follow the label instructions closely, including taking the drug for no longer than 10 days without consulting a doctor.
Why would NSAIDs increase the risk of heart attacks and strokes?
No one knows for sure. Heart attacks and strokes usually develop from a blood clot that forms in the blood vessels that supply these organs. Therefore, NSAIDs may increase the likelihood of developing such a blood clot. Researchers are still trying to understand the link.
How is Aleve different from Cox-2 inhibitors?
Aleve, ibuprofen, and the older NSAIDs work by inhibiting two enzymes in the body — called Cox-1 and Cox-2. Celebrex and its sister drugs, Bextra and Vioxx, were developed to affect only the Cox-2 enzyme. Researchers did this because inhibiting the Cox-1 enzyme had been linked to side effects such as stomach bleeding in the older drugs. That’s why these newer drugs are called Cox-2 inhibitors — because they treat inflammation by affecting only the Cox-2 enzyme.
Should I stop taking Celebrex or Aleve?
Before you do anything, it’s important to talk to your doctor to figure out the best approach for you. Each person needs to weigh the benefits of Aleve or other NSAIDs against any potential risks of these drugs. If you’re taking Aleve, you should be sure to follow the labeling instructions, which include not taking Aleve for more than 10 days without your doctor’s recommendations.
It’s also important to note that so far, only high doses of Celebrex have been linked to heart attacks and strokes. No problems have been seen in people taking 200 mg of Celebrex a day — only in people taking 400 mg a day. And problems with Bextra have been seen only in patients taking the drug for pain relief after heart bypass surgery.
What about other NSAIDs, like ibuprofen?
At this point we don’t know if other NSAIDs may also carry an increased risk of heart attacks and strokes. There is very little long-term research done on these drugs. Talk to your doctor, and the two of you can weigh the risks and benefits of your anti-inflammatory medication.
By Michael W. Smith, MD, reviewed by Charlotte E. Grayson, MD
SOURCES: WebMD Medical News: "Aleve Linked to Heart Attack, Stroke." WebMD Medical News: "Celebrex Linked to Heart Attacks." WebMD Medical News: "Arthritis Drug Vioxx Pulled Off Market." WebMD Medical News: "Heart Warning Added to Bextra Label."
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