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Bextra Pulled Off Shelves

Apr 7, 2005 | CNN

PHILLIPS: Well, important medical news to tell you about now. The drugmaker Pfizer is pulling its popular arthritis painkiller Bextra off the market.

The move comes at the urging of the Food and Drug Administration, which is also recommending the strongest possible safety warning for Pfizer's other arthritis drug, Celebrex.

CNN medical correspondent Elizabeth Cohen here to talk about what she knows about these drugs and the fact that Bextra is being pulled off the shelf.

ELIZABETH COHEN, CNN MEDICAL CORRESPONDENT: That's right.

And this is sort of yet another painkiller that's gotten into trouble. Now, I'll read you what officially what the FDA said today. They said, the FDA has asked Pfizer to withdraw Bextra from the market because the overall risk-vs.-benefit profile for the drug is unfavorable. That is a fancy way of saying that it does more harm than good.

Specifically, the harm is the studies found that people taking Bextra were more likely to have a heart attack or stroke than those who didn't, also more likely to contract a potentially deadly skin disease. And so the FDA decided to ask Pfizer. Pfizer said that they disagreed with the FDA's analysis, but that they agreed they would take it off the market.

Now, this is a very popular drug. In fact, last year, there were 12.8 prescriptions written for Bextra. And that meant $1.2 billion in sales. So, what do you do if you're taking Bextra? I'm sure you're asking yourself, what do I do? And Pfizer says stop taking it and talk to your doctor about alternatives.

But, remember, including over-the-counter painkillers, also carry risks. Now, it's important to note that some people, in consultation with their doctors, will decide that they want to continue taking drugs like Celebrex, which now has to carry a big warning about cardiovascular risks, and will want to continue to take over-the- counter drugs, despite the FDA's warning about heart and stroke risks.

And, Kyra, the reason for that is that some people are in so much pain that they have trouble going about their day. And they and their doctors may say, you know what? I'm not at a very particularly high risk of having a heart attack or stroke. So, if it elevates my risk a little bit, that's OK, because these drugs help me make it through the day. Other people are going to make different situations. It's very individual.

PHILLIPS: Well, we see that a lot of people take Bextra or took Bextra. But I bet even more take over-the-counter painkillers. So, is it still OK to take other how do you know what's OK to take now and what's not?

COHEN: It's so confusing.

PHILLIPS: Yes.

COHEN: It's so confusing. We're going to give people a little advice here. What the Food and Drug Administration has to say about over-the-counter painkillers like Advil, Motrin, Aleve, that class of nonsteroidal anti-inflammatories is, only take the dose that is recommended on the label. Take these drugs for no longer than two weeks.

And, after two weeks, see your doctor. When people really ran into trouble with these drugs, for the most part, it was when they were taking dosages that were too high and when they were taking them for month after month or even year after year after year.

PHILLIPS: All right, Bextra is getting pulled, but Celebrex is saying, but Celebrex having to have this massive warning label now. Why not just pull that one also?

PHILLIPS: Right. It's called a black box warning. And the reason why it's called that is that it's in a big black box at the top of the label. So, it's very clear, cardiovascular risk, so that you know the risk you're taking.

We asked the FDA, why are you letting Celebrex stay on the market? And they said because this deadly skin disease seems to be more likely when you take Bextra. And they said, in fact, as of December, that four people had died when they were taking Bextra from this skin disorder. So, it was really the skin disorder being associated with Bextra. That's what really tipped the scales for the FDA.


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