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Pfizer Announces Studies on Celebrex

Dec 17, 2004 | CNN MILES O'BRIEN: All right. As we've just been telling you, Pfizer, the big pharmaceutical company, is out with a statement this morning, indicating it has learned that its arthritis and pain medication Celebrex may be linked to an increased risk of cardiovascular disease. Joining us now with more on this is CNN's Elizabeth Cohen at the CNN Center in Atlanta.

ELIZABETH COHEN, CNN MEDICAL CORRESPONDENT: Miles, Pfizer is announcing the results of two studies. The first was done by the National Cancer Institute, and what they found was that people who were taking Celebrex were two-and-a-half times more likely to have, as they put it, a major cardiovascular event. Sometimes this cardiovascular event was fatal; sometimes it wasn't. When you hear major cardiovascular event, of course, you're thinking of heart or stroke.

And also, a second study they're announcing today, this one done by Pfizer. And Pfizer says that that study found that there was no increase in heart attacks or strokes when people took Celebrex.

Now, as far as the NCI study goes, the National Cancer Institute was trying to see if people, when they take Celebrex, if they actually if it could prevent them from getting cancer. But now seeing this result, they have canceled that study. No longer are patients in that study taking Celebrex Miles.

MILES O'BRIEN: All right, I'm sorry, Elizabeth. There are two studies out there. First of all, this one by the group is called the Data Safety and Monitoring Board. What is that?

COHEN: Well, the first study was done by the National Cancer Institute, and so the NCI was looking to see if, perhaps, taking Celebrex would prevent getting cancer. But instead, what they found was that it made people two-and-a-half times more likely to have some kind of a major cardiovascular event, such as a heart attack or stroke.

The second study, which showed that Celebrex wasn't a problem, that one was done by Pfizer, which makes Celebrex.

MILES O'BRIEN: OK. That's an important point. The second study, which shows no harm, is a Pfizer in-house kind of study. All right, what people right now watching this, who are taking Celebrex, what are they to do at this moment?

COHEN: Well, what you need to do is talk to your doctor, and you need to keep something in mind. In the study that found that Celebrex was a problem, people were taking both the low and the high dose, the 400 milligram and the 800 milligram dose. In the study that found that it wasn't a problem, people were only taking the low dose. So that could be something you want to talk to your doctor about.

Also important to keep in mind, some people would not be surprised by the results that show that Celebrex is a problem. Celebrex is very similar to Vioxx. It works in the same way. Vioxx, of course, came off the market in September when it was shown to have a link to heart attacks.

MILES O'BRIEN: Yes, and at the time, there was a lot of talk about, well, when will the other shoe drop here with Celebrex, and now it happens. You know, at this juncture, the company is not saying anything about advisories or pulling it off the market, are they?

COHEN: That's right. They have not said that they're going to pull it off the market. They said that they're going to review this data.

MILES O'BRIEN: All right, Elizabeth Cohen thanks for that. We appreciate it. And people on Celebrex should listen carefully today and the next few days as all of this unfolds.

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