ot: Aleve - A 4th Painkiller Is Tied to Increased Heart Risk

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A 4th Painkiller Is Tied to Increased Heart Risk

By GARDINER HARRIS

http://www.nytimes.com/2004/12/21/business/21fda.html

A new study has found that Aleve, a popular over-the-counter painkiller

made by Bayer

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could increase heart problems, and federal officials are warning

patients not to exceed the recommended dose of two 200-milligram pills a

day or continue therapy for more than 10 days without consulting a

physician.

It was the fourth big-selling pain medicine in recent months to be

suspected of hurting the heart, and federal drug officials said that

similar drugs, like Advil, might also increase heart risks.

The study, sponsored by the National Institutes of Health, was intended

to measure whether Aleve and Celebrex, made by Pfizer

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might prevent Alzheimer's disease. Nearly 2,500 patients were given one

of the two drugs or a placebo and were followed for three years. Those

taking Aleve had a 50 percent greater rate of heart problems - including

heart attacks and stroke - than those given a placebo. The Celebrex

patients saw no increase in heart events.

The latest findings follow an announcement Friday that a different

national study found that those given high doses of Celebrex had a 240

percent increase in heart problems, including death. Merck

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executives withdrew their painkiller Vioxx after a study found that it

increased the risk of heart attack and stroke by more than 100 percent.

Also, Pfizer announced recently that a study of Bextra found that it

increased the risk of heart attacks in those who have had cardiac surgery.

" This illustrates the fundamental dynamic that all drugs have risks, "

said Dr. Galson, acting director of the Food and Drug

Administration's center for drug evaluation and research. " All should be

taken carefully. "

Federal drug officials said that the entire class of painkillers known

as nonsteroidal anti-inflammatories - drugs that include Celebrex, Advil

and Mobic - could cause worrisome effects on the heart. Sales of

Celebrex, along with other anti-inflammatories like Advil and Mobic, are

expected to fall as a result.

" We know that there are other phenomena that occur across these class of

drugs, including gastrointestinal bleeding, " said Dr. Kweder,

deputy director of the F.D.A.'s office of new drugs. Heart problems " may

be another class phenomenon. "

Dr. Kweder said that the agency was studying the results of this latest

study and " will be assessing what regulatory actions are appropriate

over the next day or two. " Researchers stopped the study, but patients

will be monitored.

Patients taking a prescription form of Aleve known as Naprosyn or

naproxen should also consult their physicians, Dr. Galson said.

At the very least, the latest results could prove beneficial to Pfizer,

which has been arguing that last week's finding about Celebrex should be

placed in the context that similar pills may be just as hurtful to the

heart and that other studies of Celebrex have shown no such worries.

Indeed, if there is one message from these studies it is that nothing is

certain in this science.

" This is a very confusing situation, " Dr. Kweder said. " Every doctor and

patient is going to have to have a conversation about their unique risks. "

The results surprised many because other studies suggested that naproxen

may actually protect the heart. Some said the latest results suggested

that many pain pills were far too popular in the United States.

" I've been saying for a long time that over-the-counter Nsaid's are

extraordinarily dangerous, " said Dr. Mark Fendrick, professor of

internal medicine at the University of Michigan. Nsaid refers to

nonsteroidal anti-inflammatories, which include Aleve, Advil and Mobic.

Many critics of the drug industry say that the industry has used

widespread advertising to sell medicines to more patients than need

them. Drug makers make more than half of their sales and the majority of

their profits in the United States and drug side effects are one of the

leading causes of deaths in this country, critics say.

The one drug that is known to protect the heart is aspirin, Dr. Fendrick

said. All other painkillers are now under suspicion, he said.

But Dr. Garret FitzGerald, chairman of the University of Pennsylvania's

pharmacology department and the first to speculate that drugs like

Celebrex and Vioxx could be uniquely hurtful to the heart, said he

simply did not believe the announcement.

The heart problems found in the study have not been examined by a panel

of heart experts or statisticians, Dr. FitzGerald noted. Such a vetting

could change the results substantially, he said.

" It's much too early from the information provided to know if this is a

meaningful result or not, " he said.

Indeed, those making the announcement yesterday cautioned that the

results were preliminary. Researchers decided to stop the trial because

news of problems with Celebrex had led many of the patients to threaten

to drop out. Researchers had long known that those given naproxen in the

study had a somewhat increased risk of heart problems, but that

increased risk is not what led them to stop the study, said Dr.

Breiten of the University of Washington.

" The safety data for some time has been giving a weak signal of possible

increased risk of cardiovascular and cerebrovascular problems with

naproxen, " Dr. Breiten said.

A safety committee overseeing the trial met as recently as Dec. 10 and

decided that the results were not worrisome enough to stop the trial,

Dr. Breiten said. Only when last week's widely publicized test of

Celebrex found that that drug could more than triple the risk of heart

disease did the researchers decide to end the study and issue their

warnings about Aleve, even though Dr. Breiten said that the increase in

heart risks may not prove to be statistically significant with further

analysis.

A Bayer spokesman had no comment.

Dr. Breiten said 70 people experienced heart attacks or strokes, but he

would not give numbers for each drug group, saying those numbers would

probably change with further vetting.

Dr. Elias A. Zerhouni, director of the National Institutes of Health,

said that making a decision to suspend a trial is far different and far

easier than making regulatory decisions about those drugs. In the case

of the Alzheimer's trial, patients were taking the medicines simply in

hopes of preventing a disease, not because the medicines were providing

a needed benefit.

It is very different advising patients who need such medicines to solve

their pain, Dr. Zerhouni said.

*

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