Bextra, Celebrex, NSAIDs, and You

WebMD Live Events Transcript

The FDA has issued warnings on the entire class of NSAIDs (nonsteroidal anti-inflammatory drugs). They have recommended that the Cox-2 inhibitor Bextra be pulled from the market and that all prescription NSAIDs, including Celebrex, get revised labeling, including a boxed warning and a medication guide. Even over-the-counter NSAIDs are asked to issue revised labeling to advise consumers on their safe usage. What does this mean for you in your quest for pain relief? WebMD's Michael Smith, MD, joined us on April 8, 2005 to answer your questions.

The opinions expressed herein are the guests' alone and have not been reviewed by a WebMD physician. If you have questions about your health, you should consult your personal physician. This event is meant for informational purposes only.

MODERATOR:
Welcome back to WebMD Live, Dr. Smith. Thank you for joining us today. Yesterday the FDA issued a public health advisory that had important changes and warnings for Cox-2 selective and non-selective non-steroidal anti-inflammatory drugs (NSAIDs). The first thing they did was ask Pfizer to remove Bextra (valdecoxib) from the market. Can you explain the reasoning behind this request?

SMITH:
The FDA asked Pfizer to remove Bextra from the market because they said that it had more risks than Celebrex and other similar drugs. And since Bextra is not known to treat pain and inflammation better than other drugs, the FDA felt there was no reason to keep it around. In addition, Bextra can cause potentially serious skin reactions.

MEMBER QUESTION:
I was wondering why they pulled Bextra off the market before Celebrex. Wasn't there much controversy about Celebrex before Bextra?

SMITH:
There is more research on Celebrex than on Bextra because it has been around longer. However, all of the research on Celebrex thus far does not show any increased risk if Celebrex is taken at the regular dose of 200 milligrams per day. Bextra was shown to increase risk even at its normal dose. I think that the potential for serious skin reactions may have been what put Bextra over the edge to have the FDA want it removed from the market.

MODERATOR:
The FDA is also asking manufacturers of all marketed prescription NSAIDs, including Celebrex (celecoxib), a Cox-2 selective NSAID, to revise the labeling [package insert] for their products to include a boxed warning and a medication guide. What are they asking the manufacturers to further describe in the additional warnings?

SMITH:
A black box warning is the most severe warning that the FDA applies to drug labels. In this case, the black box warning will warn of the potential risks of heart attacks, strokes, and stomach ulcer bleeding. This warning applies to all prescription anti-inflammatory drugs on the market.

The medication guide will be information provided to the patients at the time these drugs are prescribed to help them understand these risks. The FDA is applying this warning to all prescription anti-inflammatory drugs but the absolute risk isn't really known. This is because there is not a lot of research looking at the heart and stroke risks of all of these drugs.

MEMBER QUESTION:
What kind of skin reactions does Bextra cause?

SMITH:
The most serious skin reaction that has been seen with Bextra is called Stevens-Johnson syndrome. In this condition, the skin essentially sloughs off as if someone sustained a serious burn. It can be widespread over the entire body and has caused death in a few people. Although it's rare, since Bextra doesn't seem to offer any particular advantages over Celebrex or other drugs, the FDA felt it wasn't needed on the market.

There are other minor skin reactions as well -- more in the form of allergies. But we aren't able to determine who is likely to have these serious skin reactions.

MODERATOR:
Is this reaction only with Bextra? What about other Cox-2 inhibitors?

SMITH:
This severe reaction has really only been reported with Bextra. However, Celebrex, the other Cox-2 inhibitor on the market, can cause the more minor skin reactions. All anti-inflammatory drugs have the potential for these minor skin reactions. But the more serious reactions have not been associated with these drugs.

MEMBER QUESTION:
So if a person has been taking Bextra for a period of time, besides stop taking it immediately and talking to your doctor, should one have their heart checked out?

SMITH:
With Vioxx, people asked the same question. Available research and experts believe that once someone stops taking these drugs the risks of heart attacks and strokes goes down fairly rapidly.

One thing I want to be sure that people understand is that other risk factors, such as high cholesterol, high blood pressure, smoking, etc. are much stronger risk factors for heart attack and stroke.




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