Video: Confusion over Aleve warning

By Robert Bazell Chief science and health correspondent
NBC News
updated 12/21/2004 11:15:36 PM ET 2004-12-22T04:15:36

An Alzheimer’s disease prevention trial was suspended after researchers said there were more heart attacks and strokes among patients taking naproxen, an over-the-counter pain reliever in use for 28 years and commonly known by the brand name Aleve.

The announcement has called into question widespread use of the common pain reliever and left many consumers wondering whether they should discontinue their doses. But does naproxen really pose a danger to ordinary consumers or is it a victim of the FDA's overly cautious approach in the wake of the recent warnings about Vioxx and Celebrex?

NBC News’ Robert Bazell tries to dispel fears that there is a large-scale problem with naproxen, and answers questions about the continued use of the drug by consumers.

Q: What does the FDA warning mean for regular users of Aleve?
A:
For people who use Aleve according to the directions on the bottle, increasingly experts are saying today that this (FDA warning) doesn't mean much at all. In fact, there may be no danger. Increasingly experts are saying (the results of the study) may be a statistical fluke and there may be no danger at all.

Q: Does the FDA warning only apply to people taking large doses of naproxen?
A:
It really has nothing to do with the dosage. What happened was this trial was halted not because the committee of outside experts, known as the Data and Safety Monitoring Board, looked at it and said that there was a danger from heart disease — that’s what happened in the case of Vioxx and one of the trials with Celebrex.

What happened was this trial was halted because people didn't want to take part in it because of what happened with Celebrex — so they were having trouble finding volunteers.

So for statistical reasons, there is not the same kind of analysis.

There are years of data (on) naproxen, sold as Aleve, indicating that it not only does not increase the risk of heart disease, but it is protective against heart disease in the same way aspirin is.

A lot of studies added together say that aspirin reduces the frequency of heart disease by about 25 percent, (and) Aleve or naproxen reduces heart disease by about 10 percent. So this single study appears to be some kind of fluke.

Either it is some kind of fluke because of the high dosage used in the study or because of the way the data was analyzed. In any case, I don't think that it gives people who use naproxen any reason to be concerned.

Q: What is the relationship between this latest announcement and the recent problems with other Cox-2 inhibitors?
A:
Regular users don't have to be concerned at all. This is very different from the situation with Vioxx, Celebrex and Bextra — those drugs are all called Cox-2 inhibitors. They are also anti-inflammatory pain-relief drugs that are used a lot for arthritis.

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But for years there has been data accumulating that indicate the possibility that those drugs increase the risk for heart attack and stroke.

But with naproxen, it's just the opposite. For years there has been data accumulating indicating that naproxen decreases the risk for heart attack and stroke. So this one study flies in the face of everything else we've been hearing about naproxen.

There have not been any warning signs, so it would be highly unlikely that this drug is actually a danger.

There was a head-to-head study done by Merck comparing naproxen and Vioxx for the treatment of arthritis and that was the study where people taking Vioxx had five times the number of heart attacks and strokes, so we're really talking about something that's completely different.

Q: Is there a connection to how the FDA reacted to naproxen and the recent problems with Vioxx?
A:
Well, there is the relationship in the sense that the regulators, the FDA and the NIH, now have a hair trigger in terms of how quickly they get concerned about things. They got concerned about this in a big hurry and released the information in a big hurry, perhaps alarming the public unnecessarily.

Q: Does this call into question the way that the FDA monitors drugs that are on the market?
A:
Yes, the process of how the FDA monitors the safety of drugs that are already on the market — which is where the big problem is — has been called into question a great deal by the withdrawal of Vioxx, which was not done by the FDA, and the hearings that followed. The FDA's process for monitoring the safety of drugs has been called into question indeed.

This particular incident with naproxen only is part of that process in the sense that the FDA —because they have been under fire so much — may have acted too quickly.

Q: So, was this too hasty a warning?
A:
It was a mild warning. They said that people shouldn’t take it for more than ten days before they talk to their doctor. In those ten days, the data will probably get sorted out and we'll figure out what's going on.

Q: What is the bottom line for consumers?
A:
The bottom line for consumers is that there is reason to be concerned about Cox-2 inhibitors. Vioxx has been taken off the market, so that is not even a decision. Pfizer is still selling Celebrex and Bextra — its two Cox-2 inhibitors. The FDA has advised that if you're thinking of taking these drugs you should really talk to your doctor about whether you should continue taking them or if you can get by with another anti-inflammatory drug.

As far as Aleve goes, for right now, take a breath; keep taking your Aleve and don't exceed the recommended dose.

But there is a good reason to believe that this will calm down and possibly end up being a statistical fluke and that there doesn't seem to be any danger from Aleve.

Robert Bazell is the NBC News Chief Science Correspondent.

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