Disadvantages of COX-2 inhibitors

by Nathan Wei, MD, FACP, FACR

Nathan Wei is a nationally known board-certified rheumatologist and author of the Second Opinion Arthritis Treatment Kit. It's available exclusively at this website... not available in stores.

Click here: Second Opinion Arthritis Treatment Kit

The American College of Rheumatology, the national scientific organization that represents most rheumatologists came out with this position paper on COX-2 drugs following the FDA advisory committee meeting which took place on February 14-17, 2005.

This report should be taken with a grain of salt and I have comments at the end of this page indicating why.

Over 70 million Americans are affected by arthritis and musculoskeletal disorders. One of the mainstays of treatment for these conditions for more than three decades has been medications in the class known as the non-steroidal anti-inflammatory drugs or NSAIDS.

NSAIDs are medications that work like aspirin by decreasing inflammation, pain, and fever. An important problem with the traditional NSAIDS, which include ibuprofen, naproxen and many other generic and brand name drugs, is their tendency to irritate the stomach, with the possibility of more serious complications such as an ulcer, stomach bleeding, colon or small bowel irritation, or –less likely–perforation of an ulcer.

Some patients are at higher risk for these problems, including people over the age of 65, those who have already had a bleeding ulcer, and people who take blood thinners or corticosteroid medications such as prednisone.

In 1999, a new type of medication, called the COX-2 selective NSAIDS, was introduced to treat the pain of arthritis. The COX-2 NSAIDS – rofecoxib (Vioxx), celecoxib (Celebrex), and valdecoxib (Bextra) - are somewhat less likely to cause stomach ulcers that can occur with traditional NSAIDs.

However, recent studies suggest that COX-2 selective drugs are associated with an increase in the risk of heart attacks and strokes – especially when they are used at higher doses. After those reports, the company that makes Vioxx decided to take it off the market. Data is still being analyzed and evaluated by physicians, scientists, public advocacy groups, and the Food and Drug Administration (FDA), the federal agency that oversees drug approval and safety in the US.

Recently, an advisory group to the FDA recommended that the COX-2 NSAIDs remain available for patients, with stronger warnings about the cardiovascular risks. Bextra was also removed from the market shortly after Vioxx was.

Although some patients may experience more pain and inflammation relief with one NSAID than another, studies show that, as a group, the COX-2 NSAIDs are not more effective in controlling arthritis pain than the traditional NSAIDs like ibuprofen, naproxen, diclofenac and others. They also share the other side effects of traditional NSAIDs such as the potential for causing an increase in blood pressure, fluid retention, and problems with kidney function. The only advantage of COX-2 NSAIDs is that they may be less likely to cause ulcers and bleeding.

It is very important to remember that not all patients are at the same risk for the side effects from these medications. Someone with a pre-existing heart condition, high blood cholesterol, high blood pressure, a previous stroke or risk factors for a stroke would be more likely to have problems with these medications. Children are much less likely to experience stomach and intestinal problems with these medications than adults, and there are no reports of cardiovascular problems in children taking NSAIDs.

As with all medications, other side effects may occur. With both the traditional and COX-2 selective NSAIDs, other less frequent problems can include liver problems and allergic reactions such as hives, rashes and asthma.

If you are taking one of these medications or considering using them in the future, here are some things to discuss with your doctor:

• Make sure he or she knows your entire medical history, including history of ulcers or other stomach problems, heart disease, high blood pressure and stroke, and medication allergies.

• Discuss any side effects or problems you think you have had with your current or previous NSAID drugs
• If an NSAID is needed, talk about the relative benefits to you of using a traditional NSAID versus a Cox-2 selective NSAID.

• If you use a traditional NSAID, ask whether you should also take a medicine to protect the stomach. Over the counter medicines such as omeprazole (Prilosec) or famotidine (Pepcid) and prescription drugs such as omeprazole (Prilosec), esomeprazole (Nexium), pantoprazole (Protonix), lansoprazole (Prevacid), rabeprazole (Aciphex), or misoprostol (Cytotec) can be used.

• If you are taking (or will be taking) low dose aspirin, ask if aspirin use will this affect the choice of an NSAID.

• If you and your physician decide that a COX-2 NSAID is the best choice for you, take the lowest dose that gives pain relief and consider taking it for limited periods of time.

Be knowledgeable about all of your medications, and review information from your doctor, pharmacist, and other health care provider about both effectiveness and side effects.

• Always ask your doctor, pharmacist, or other health care professional if you have questions about your medications

• Tell your doctor about all of medications you are taking, including medicines prescribed by other doctors, over-the-counter medicines and other supplements.

• The best decision about what medication is best for you is a shared one between you and your doctor, taking into account your medical history and current medical problems, other medicines needed, and a discussion about the relative benefits or risks of medications.

The American College of Rheumatology (ACR) is a professional organization representing more than 6000 physicians, scientists, and other health care professionals who treat arthritis and other musculoskeletal and inflammatory diseases.

Since then, there have been clarifications. For example, it is clear that all NSAIDS regardless of whether they are COX-2 or not carry the same risk for cardiovascular events such as heart attack or stroke.

I do have a couple of additional comments. Celebrex plus aspirin causes the same risk for gastrointestinal events as does a plain NSAID. Also Celebrex has the same deleterious effect on kidney function as plain NSAIDS. Other than that, I think it's a great NSAID and I have no problem recommending it for patients who need an NSAID but who are not sulfa allergic.

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