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Pfizer Pulls Bextra

Apr 7, 2005 | CNN

First, though, there is important medical news that you need to know about. The drugmaker Pfizer is pulling its arthritis painkiller Bextra off the market. The Food and Drug Administration asked for the recall. The FDA also called for the strongest possible warning on Pfizer's other big arthritis painkiller, Celebrex.

Our medical correspondent Elizabeth Cohen standing by with important details.

Elizabeth, what's going on?

ELIZABETH COHEN, CNN MEDICAL CORRESPONDENT: Wolf, well the Food and Drug Administration has just had a press conference, and issued this statement. And in it they say the FDA has asked Pfizer to withdraw Bextra from the market because the overall risk versus the benefit profile for the drug is unfavorable.

Well, that's a fancy way of saying that when they looked at the data, Bextra did more harm than good. And the harm, specifically, is an increased risk of having a heart attack or stroke while taking Bextra, and also an increased risk of having a potentially life-threatening skin condition.

So, now, of course, the big question for Bextra users is, what do I do? Well, Pfizer says stop taking Bextra. Stop taking it and talk to your doctor, those are the instructions from Pfizer. And they also say, when you talk to your doctor about alternatives, remember that other painkillers also carry risks.

Wolf, you mentioned Celebrex, and the FDA has said that Celebrex now needs to carry it's called a black box warning. That's a warning in a big prominent black box that talks about the heart attack and stroke risk and also the increased risk of having gastrointestinal bleeding.

The sales for Bextra have been very high, of course won't be high much longer. 12.8 million prescriptions for Bextra were written in 2004. $1.2 billion in sales.

Now, Wolf, another thing that people need to remember is, if they're take Celebrex, or even if they're taking over-the-counter painkillers, which also carries some increased risk, for some people those risks are worth it. Some people are going to say, "My pain is so bad I can't really live my life the way I want to." And they and their doctor together might decide that it's worth them continuing to take these drugs Wolf.

BLITZER: What about the people who would take these painkillers, especially the over-the-counter painkillers? What are they supposed to do now?

COHEN: Right. Well, they also should talk to their doctor, and the should follow the Food and Drug Administration's advice. And that advice specifically is to take the dose that's recommend on the label. Take it for no longer than two weeks. If you want to take it for longer than two weeks, you need to talk to your doctor.

Wolf, the problems that the FDA found when people were taking over-the-counter drugs like Advil or Alleve, they tended to be when people took them for a long time and at high doses.

BLITZER: The FDA asked for Bextra to come off the market, but Celebrex still staying on the market. Why?

COHEN: What tipped the scales apparently, according to the FDA, is that Bextra seemed to have a more severe relationship with this life-threatening skin condition. In fact, in December, they said that four people had died because of this skin condition when they were taking Bextra.

So it was the skin condition, not the heart attack and stroke risk. The heart attack and stroke risk seems to be the same with Celebrex and Bexra, but the skin condition seems to be worse for people taking Bextra.

BLITZER: Elizabeth Cohen reporting for us important information, medical information. Thanks, Elizabeth, very much.


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