NSAIDs: FDA Warning on Bextra, Celebrex (cont.)

There is no reason to rush to have your heart checked out. However, it's a good idea to discuss your risk with your doctor. If the two of you determine that your risk of heart disease may be elevated, then further testing may be warranted.

MEMBER QUESTION:
I felt that Vioxx and Bextra effectively eased the pain and inflammation of my rheumatoid arthritis (RA), much more than Tylenol. Could it be that there is no pharmaceutical solution to moderate RA pain?

SMITH:
Vioxx and Bextra are anti-inflammatory drugs. Tylenol is not an anti-inflammatory drug. It's unusual for Tylenol to help significantly with RA pain. However, Vioxx, Bextra, and Celebrex have not been shown to relieve pain more than the other prescription anti-inflammatory drugs.

There are about 20 of these drugs available so you have many more options. The only people that may have a more absolute reason to take Celebrex over the other prescription anti-inflammatory drugs are people who have had a stomach ulcer. I have actually had a stomach ulcer from ibuprofen and therefore I am taking Celebrex. But most other people do not need Celebrex and can take one of the other anti-inflammatory drugs.

MEMBER QUESTION:
I suffer from RA and ulcerative colitis. My doctor put me on Mobic recently and I've been experiencing more intense and more frequent flares. What are my choices now? Are all NSAIDs considered unsafe?

SMITH:
I suspect that your doctor put you on Mobic because it's felt to be a little easier on the stomach and intestines than some of the other drugs. However, there isn't a lot of evidence to back that up.

As far as the risks, all of the prescription anti-inflammatory drugs have been lumped into the same risk category at this point. This means they all carry some risk of heart attack and stroke.

However, it's important to keep in mind that when you have RA or moderate to severe osteoarthritis (OA) you don't really have much choice but to take one of these drugs. I wouldn't call them all unsafe. Yes, they all have risks. But they definitely all have their benefits as well. I think people should take the drugs if that's what they need. And then address other heart disease risk factors, such as diet, exercise, cholesterol, smoking, etc.

MODERATOR:
However, we are not likely to see either Vioxx or Bextra return to the market, are we?

SMITH:
While it's possible, it's highly unlikely. Pfizer says they are going to talk to the FDA more about putting Bextra back on the market. And Merck has also said that they would do the same. However, the FDA said yesterday that they would need a lot more safety data on these drugs to bring them back. This means that if they were to return, which I think is highly unlikely, it would likely be years before that happened. They don't seem to have any advantages over other available drugs.

MEMBER QUESTION:
Is over-the-counter Celebrex as effective as the Rx Celebrex?

SMITH:
There is no over-the-counter version of Celebrex. Celebrex is only available as a prescription.

MEMBER QUESTION:
How come they haven't pulled Celebrex off the market yet? Do they feel it is actually safer than Bextra and Vioxx?

SMITH:
Yes, the FDA says that after looking at all the data the benefits of Celebrex appear to outweigh the risks. At the normal dose of 200 milligrams of Celebrex a day, there doesn't really appear to be much increased risk of heart attacks and strokes. The studies that have shown an increase in risk have been cancer prevention studies. In these studies, Celebrex was taken at doses of 400 to 800 milligrams a day.

MEMBER QUESTION:
RA itself can negatively affect the heart and lungs, correct? Then those of us who have RA already have a risk factor, correct?

SMITH:
That's a good point. People with RA already have a somewhat higher risk of heart problems. However, people with RA also really don't have much of a choice than to take an anti-inflammatory drug. Therefore, you take the drug and just know that there is some risk associated with it but don't beat yourself up about it. I'm taking it because I know I don't really have a choice.

What I hope people will do is address the other risk factors that I've talked about and lower their risk of heart disease and strokes in that way. Also, we don't really know what the real risks are. There is little research done on most of these anti-inflammatory drugs. It's likely that the increase in risk is fairly small and not something that we all need to be constantly worrying about. However, it's something that we should be aware of.

MEMBER QUESTION:
What other medicine besides Bextra can I use with Coumadin?

SMITH:
Celebrex can be used with Coumadin. If that doesn't work for whatever reason, you can talk to your doctor about other possibilities. The older anti-inflammatory drugs may be just as safe as long as you take a drug to suppress acid production in your stomach.

MEMBER QUESTION:
NSAIDs, which I took about 10 years ago, made me feel debilitating nausea. Are there better NSAIDs now?

SMITH:
Yes, some of the more recent NSAIDs are associated with less nausea. Mobic and Relafen are two possibilities. Talk to your doctor if you need to take an NSAID. You may have to try several to find one that works for you as far as the nausea.

MODERATOR:
The FDA is also asking manufacturers of over-the-counter NSAIDs to revise their labeling to include more specific information about the potential gastrointestinal and cardiovascular risks and to add information to assist consumers in the safe use of the drug. Would you comment?

SMITH:
There is little research on the risks of over-the-counter NSAIDs and heart attack and stroke. However, the FDA feels that there is the potential for risk and thus they are asking the makers of these drugs to include information on the labeling. However, the warning will not be as strong as on prescription drugs. It's felt that the lower doses of over-the-counter drugs make them less risky.



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