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4th Painkiller is Tied to Increased Heart Risk

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Misty L. Trepke

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A 4th Painkiller Is Tied to Increased Heart Risk

By GARDINER HARRIS

December 21, 2004

 

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

hp & ex=1103691600 & en=112ea3a8ea08ea78 & ei=5094 & partner=homepage

 

Correction Appended

 

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

painkiller made by Bayer, 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, 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

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. Steven 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. Sandra

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. John 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.

 

 

Correction: December 23, 2004, Thursday:

 

A front-page article on Tuesday about a study that found that Aleve,

an over-the-counter painkiller, could increase heart problems

misspelled the surname of a University of Washington researcher who

commented on reasons for ending the study. He is Dr. John Breitner,

not Breiten.

 

=====

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