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Last reviewed by Faculty of Harvard Medical School June 27, 2013
All of the nonsteroidal anti-inflammatory drugs, or NSAIDs, have been tainted by stories of potential heart problems; that is, all of them except aspirin. First, Vioxx was withdrawn from the market, then Bextra. Celebrex is the only selective COX -2 inhibitor that remains. And the concern goes beyond the COX-2 inhibitors. Since 2005, the U.S. Food and Drug Administration (FDA) requested the manufacturers of all prescription NSAIDs — including older over-the-counter medications such as ibuprofen (Advil, Motrin, and generics) and naproxen (Aleve and generics) — to revise their labels. The FDA wants to see a clear warning of the potential increased risk of cardiovascular problems, in addition to other side effects already listed, such as stomach irritation and skin reactions.
However, most experts believe that the older NSAIDs do not pose much, if any, risk to the heart, and there is some evidence to suggest that naproxen may even be beneficial. After all, like aspirin, the older NSAIDs slow down the actions of platelets. But naproxen and the other NSAIDs are going to be stuck with this warning for the foreseeable future — probably forever.
The problem is that the FDA has been given an impossible task — to prove a "negative," to verify that these drugs do not harm the heart. The problem is worsened by the fact that most of the older NSAIDs are generic and some are available over the counter. So no drug company is going to sponsor the huge trials that would be needed to prove with certainty that they are safe.
So what are you supposed to do about your aching back? Here is what I am telling my patients:
Try acetaminophen (Tylenol) first. It is inexpensive, quite safe when used as directed on the bottle, and is a surprisingly good pain reliever. If this drug doesn't work, I recommend naproxen, which several studies have found to be associated with a reduced risk of heart disease. It is available over the counter as Aleve or in generic form. Stronger doses are available by prescription (Naprosyn and generics).
If someone needs naproxen but has an increased risk of bleeding stomach ulcers, I will still use naproxen, but I also put the patient on a proton pump inhibitor (a class of drugs that reduces acid in the stomach), such as omeprazole. This drug is available over the counter, too, as Prilosec.
If the patient does not get relief from naproxen, I will try other older NSAIDs, especially ibuprofen. I also combine NSAIDs with acetaminophen in some patients, and get greater pain relief than with either alone.
The only remaining COX-2 inhibitor on the market, Celebrex, does not give any greater pain relief than the other NSAIDs and is much more expensive. So I rarely start pain treatment with Celebrex. However, some patients do respond better to one particular NSAID, and every doctor has a few patients who seem to benefit more from Celebrex than other NSAIDs.
I often wonder if an NSAID preference comes from the influence of television ads, but if it makes a patient feel better and risks are equal, I will prescribe the NSAID the patient desires.
The bottom line: It is likely that the FDA is being overly cautious by imposing the requirement of a warning on all NSAIDs, and older drugs like naproxen are probably quite safe. That said, acetaminophen is a terrific pain reliever that is often overlooked, and is worth a try as the first option for people with musculoskeletal and other causes of pain.
Thomas H. Lee, M.D. is the chief executive officer for Partners Community HealthCare Inc. He is a professor of medicine at Harvard Medical School. He is an internist and cardiologist at Brigham and Women's Hospital. Dr. Lee is the chairman of the Cardiovascular Measurement Assessment Panel of the National Committee for Quality Assurance.
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