Drug Safety: Bextra

JEFFREY BROWN:

First it was the blockbuster arthritis drug VIOXX pulled from the market last September, then news that an entire group of painkiller drugs could pose health risks.

Today the FDA took further action and Pfizer, which for the record is an underwriter of the NewsHour, suspended sales of a drug called Bextra. Here to tell us about all of this is our health correspondent, Susan Dentzer.

Susan, first set the table a little bit for us. What has been the issue lurking out there these last few months?

SUSAN DENTZER:

Well, Jeff, when VIOXX was pulled from the market, it was back in September, it was because a company run study done by the manufacturer, Merck, had shown that there was a doubling of the risk of heart attack and stroke for patients who took the drug at least 18 months. That cast a cloud immediately over the other so-called COX-2 drugs, including Celebrex and Bextra, made by Pfizer.

Further, people started to ask, well, if it's true for those drugs, is it also true for the big family that these drugs are a part of, which are called NSAIDS, non-steroidal anti-inflammatory drugs, so what has been going on for the last several months is the Food and Drug Administration and others have been pulling together all the existing studies on that, looking closely at it, examining the fact that studies have shown higher cardiovascular risks also for Celebrex and Bextra, and trying to figure out what to do about it. That's really — the culmination of that is what happened today.

JEFFREY BROWN:

In February an advisory committee said that yes, there are some risks, but these drugs should be available to people who need them. Today, though, the FDA said something different, at least in the case of Bextra.

SUSAN DENTZER:

Well, the advisory committee recommendations were a clear vote, there was a majority vote in each case but they were very complicated. The committees were split over whether to leave, for example, Celebrex on the market or leave Bextra on the market, because studies had indeed shown higher cardiovascular risks, more heart attacks and strokes, small risks, but when you apply those to the huge populations of people taking these drugs, lots of people were having heart attacks and strokes and lots of people were clearly dying because of that.

So the committees didn't roll over and say keep these on the market, but they did say weighing the pluses and the minuses, Celebrex seemed to many of the committee members to have enough benefits, there was a feeling that maybe you could identify who was most at risk for heart attacks and strokes, keep people like that away from this drug, still keep it on the market.

What happened, though, today was that the Food and Drug Administration clearly said Bextra's risks outweigh the benefits. They said a couple of things. In particular, they zeroed in on the fact that Bextra in addition to having higher risks of heart attack and strokes, like Celebrex, also provoked in some people severe skin reactions, severe allergic skin reactions and not just, you know, itchy rashes, skin reactions that could actually kill people, and in many cases did.

JEFFREY BROWN:

This was quite a new side effect.

SUSAN DENTZER:

Well, this had been seen actually since the day that the drug was on the market, and so-called adverse event reports have been coming in over the last several years to the FDA, and in fact a warning was put out on the drug several months ago. What happened today was that the FDA sort of put all of this into its mental cuisinart and said you know what, the risks here outweigh the benefits of this drug, the FDA went to Pfizer, asked Pfizer to pull it off the market, we're told Pfizer reluctantly agreed to do that and Pfizer said in a statement today it would continue to work with the FDA to try to get the drug on the market in a limited way for certain people.

JEFFREY BROWN:

Now, the FDA also called for stronger warning on Celebrex, a so-called black box warning. What does that mean what would it say?

SUSAN DENTZER:

A black box warning is the stiffest form of a warning that can be put on a drug that is still on the market. And in fact the FDA is going to require Pfizer now, it will help Pfizer write the language that says this drug should not be taken by people who have other cardiovascular risks, and note some other risks as well. So it's the stiffest form of warning and this type of warning goes to physicians; it's meant to warn physicians about how to influence prescribing.

But, importantly, the FDA took another step today which is it said not only are there risks involving these particular drugs, the so-called COX-2 inhibitor drugs, that they really probably are shared broadly across this whole class of NSAIDS, which includes, —

JEFFREY BROWN:

Tell us what NSAIDS is.

SUSAN DENTZER:

Again it's non-steroidal anti-inflammatory drugs. And these drugs include very common over the counter preparations like Ibuprofen, like Aleve.

And what the FDA said is all these drugs have some risks, we don't know a lot about these risks, but in fact the FDA said the labels, the labels on the bottles of even those drugs now need to contain and hence forth will need to contain information about the risks of cardiovascular effects, the risks of skin effects, skin reactions, like we saw in Bextra, and also some additional risks to the gastrointestinal system, the stomach bleeding that has been a factor with many of these drugs for some time.

JEFFREY BROWN:

So a person can still go in and buy these over-the-counter drugs, but the warning will be made clear if I or you go in, it will be clear?

SUSAN DENTZER:

Absolutely; it's going to say at some point in the future it's going to say right on the label, be careful about these drugs for these risks. The FDA hastens to add that if consumers use these drugs according to the directions, that is for, you have a headache or whatever, you take Ibuprofen, short-term use, lowest dose possible, best anybody knows, it's safe. But it's the longer-term use at high doses that really we don't understand the risks of, and that's why the FDA has asked for these warnings.

JEFFREY BROWN:

Now there have been of course a number of critics who wanted the FDA to act quite forcefully in this matter. What reaction did you get today?

SUSAN DENTZER:

Well, as usual, as is always the case when the FDA acts, everybody is unhappy about something. Even people who applauded the move to pull Bextra off the market said Celebrex should have been pulled off the market as well. Again the FDA's response is no, we think we can figure out who, roughly speaking, who could be on this drug safely and that option should be available to people who need that pain relief that they believe they get from Celebrex. Others really cast doubt over this decision on the part of the FDA to create a cloud over all the non-steroidal anti-inflammatory drugs. There was a sense among many people I spoke to today that this was going to confuse consumers, was going to make consumers think that Ibuprofen is as dangerous perhaps as Bextra, and it might really just create more confusion than necessary for individuals who suffer from these painful conditions like arthritis.

JEFFREY BROWN:

So that leads to the last brief question. What does a consumer do now?

SUSAN DENTZER:

Well, the FDA issued the tried and true advice today, talk to your physician first and foremost. And physicians now will have more information coming through these expanded so-called drug labels and warnings. Talk to your physician, once again go over your inherent risks for heart attack or stroke; figure out if you are on the lowest dose or how you can get there. Look at other options. Some of the critics said today the FDA should have gone farther and said you can take certain combinations of drugs, one drug, Naproxen sold as Aleve with, for example, another drug like Prilosec, a so-called proton pump inhibitor, and get stomach protection from that. So there are all kinds of different solutions now that are going to have to be tried by physicians if people want to stay away from some of the risks of these other drugs.

JEFFREY BROWN:

Okay, Susan Dentzer, thanks again.

SUSAN DENTZER:

Thanks, Jeff.