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A Look at the Drug Celebrex and it's Side Effects

Dec 18, 2004 | CNN ELIZABETH COHEN: Good morning, and welcome to HOUSE CALL. I'm Elizabeth Cohen in for Dr. Sanjay Gupta.

According to a new study, more Americans die from heart attacks and other natural causes during the holidays than at other times of the year. Researchers say one reason may be that people delay seeking medical treatment for symptoms over the holidays.

And just 24 hours ago, news that another popular drug may increase the risk of heart problems. This time, it's the painkiller Celebrex. The news about Celebrex comes about three months after similar concerns about Vioxx. That drug was pulled from the shelf. This latest scare is our top story.

It's another blow to millions of Americans who suffer from arthritis. The drug company Pfizer is warning of a possible link between Celebrex and heart problems. It's raising all sorts of questions about the safety of what's in your medicine cabinet.

ANNOUNCER: These are just a few of the 23 million people who have discovered Celebrex.

COHEN: It's been one of the bestselling drugs in history. But today, a bombshell. A government study says people taking Celebrex are two and a half times more likely to have a heart attack or a stroke. The study, which has not been made public, came from the National Cancer Institute. It was investigating whether Celebrex might help prevent cancer. Now the researchers have stopped using Celebrex in the study. And the Food and Drug Administration is telling doctors to consider alternative pain relievers for their patients. And if a doctor determines the benefits of the drug are worth the risk, the doctor should prescribe the lowest effected dose.

Now many are wondering why did it take nearly five years to notice that this blockbuster drug, which has been used by 27 million Americans, could cause heart attacks?

Dr. David Graham is the Food and Drug Administration safety expert who blew the whistle on a similar drug, Vioxx. He says the system has completely broken down.

DAVID GRAHAM, DR., FDA: The FDA is incapable of protecting the United States against unsafe medicines.

COHEN: When Vioxx, which is in the same family as Celebrex, was shown to have a similar risk, it was pulled off the market. So does that mean the FDA wants Celebrex off the market, too? The agency says no, they want to study the data further and that safety problems are inevitable.

LESTER CRAWFORD, DR., FDA ACTING COMMISSIONER: We can never be fail safe, though, because we're dealing with products that are very difficult to evaluate.

COHEN: Pfizer defended its drug Friday, saying its own study showed no heart or stroke problems.

HANK MCKINNEL, CHAIRMAN, CEO, PFIZER, INC.: We do know from a wealth of other information, some from FDA studies from some from our studies, some for others, that Celebrex, when taken as recommended at the doses recommended is safe and effective.

COHEN: Now the dose patients took in the study, the dose that puts them at an increased risk for heart attacks is the dose recommended by Pfizer, 400 milligrams a day. Now many will be watching Pfizer to see if it takes Celebrex off the market or perhaps if the FDA pressures the company to do so.

Now this could affect millions of people around the world. Celebrex is used to treat common ailments like arthritis, menstrual pain, as well as intestinal polyps. We want to hear your questions about Celebrex.

Joining us now to help us answer those questions is Dr. Marie Griffin. She's a professor of preventative medicine at Vanderbilt University and an expert on drug safety. Welcome, Dr. Griffin.


COHEN: Now doctor, should people stop taking their Celebrex?

GRIFFIN: Well, we believe that people at high risk of heart disease, this poses a threat. And so they should definitely talk to their doctor sooner rather than later.

There's no danger of immediately stopping this type of drug. I think the danger is that people get worried about all their drugs and say, you know, these are bad things. And they shouldn't be afraid of their other drugs. But there's no danger with stopping these types of pain relievers.

COHEN: Now the dosage in the study was 400 milligrams. That's what put gave people that two and a half times increased risk of having a heart attack or a stroke. Is this the dosage that's commonly taken?

GRIFFIN: It is a dosage that's commonly taken, although if you read the recommended dose, it's not the dose that's recommended for many people. But many people do take this dose. It really is only recommended for short-term use or for people with rheumatoid arthritis, but many people take this dose. Yes.

COHEN: Now you co-authored a letter to The New England Journal of Medicine this week, advising against he use of another Cox II inhibitor. That's the class of drugs we're talking about here, that this one's called Bextra, the one that you wrote about. What's dangerous about this class of drugs?

GRIFFIN: Well, we now have I think we've learned something since the Vioxx episode. There was concern that all three of these drugs, these new Cox II inhibitors, might cause heart attacks and strokes. And we got the first signal from Vioxx. Now we have a signal from both Bextra and Celebrex. And I think it makes it more clear that the basic science was probably correct in suggesting that all these drugs could increase the risk of heart attack and stroke. So it's very concerning.

COHEN: And that basic science was known, as I understand it, pretty early on in the game, the basic science said that there could be an increased risk of heart attack.

GRIFFIN: Exactly. But what the real proof is when if you see this in patients. So a lot of times the basic science, it may not pan out in patients. So but when you start seeing what the basic science predicts, that's a very strong signal. And now when we're seeing it in both of the other drugs, I think that we have to be very cautious about using these drugs. COHEN: Well, we have a question now, an e-mail question from Glenn in Florida. And Glenn says, "I was prescribed both Celebrex and Vioxx for two years. I haven't taken either for a couple of years, but is there any long-term risk after discontinued use?"

Dr. Griffin, I know a lot of people are wondering this. If you took Celebrex, Vioxx or Bextra and stopped, are you still at an increased risk for heart attack or stroke?

GRIFFIN: We don't think so. From what we know about these drugs, the effects should be just while you're taking the drugs. So people should not worry about past use.

COHEN: Well, good. I know that will make a lot of people breathe easier. We've got to take a break now. When we come back, we'll talk about options. From arthritis to painful injuries, what should you do for pain relief? We'll discuss alternatives right after the break.

COHEN: Welcome back to HOUSE CALL. We're taking your questions on the latest concerns about Celebrex. Talking with us this morning is Dr. Marie Griffin, a drug safety expert and professor of preventative medicine at Vanderbilt University. Welcome, doctor.


COHEN: Vioxx is off the market, as everybody knows. And you've advised doctors to stop prescribing Bextra. And now we have this latest Celebrex study. Well, we have a question from a viewer. Lori from Connecticut writes, "Celebrex doesn't work and Bextra is marginal. I am very concerned about what I can use instead."

Any recommendations for Lori, doctor?

GRIFFIN: Sure. Well, it depends on what she's taking the drugs for. And her experience is not unlike many people. The drugs work really great for about 20 percent of people. And for the rest, they may provide a little bit of relief.

So first of all, there are a lot of other things for joint pain, such as trying to strengthen your muscles and your joints, doing exercises, heat and cold. And then over-the-counter medicines like Tylenol are really safer than these drugs. And if you're at the point where you these drugs really help, then the older drugs that we've had around for a long time like Ibuprofen and Naprosyn are certainly alternatives.

COHEN: Now sometimes doctors prescribe Celebrex for, let's say a sports injury or some kind of short-term problem. So that you're not taking it for very long. Is that a safer use of Celebrex because it's for a short period of time?

GRIFFIN: Well, obviously if you take it for shorter, you limit your risk. But it's really no more effective than the older drugs for that type of injury. And so, at this point, I don't really see that there's any benefit to using this drug where we're questioning the safety, as far as cardiovascular risk, as far as heart attacks or strokes.

COHEN: Well, thank you, Dr. Griffin.

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