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A Fourth Painkiller Is Linked to Increases in Heart Problems
NY Times ^ | December 21, 2004 | GARDINER HARRIS

Posted on 12/20/2004 8:12:42 PM PST by neverdem

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 N.S.A.I.D.'s are extraordinarily dangerous," said Dr. Mark Fendrick, professor of internal medicine at the University of Michigan. N.S.A.I.D. 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.


TOPICS: Business/Economy; Culture/Society; Front Page News; Government; News/Current Events; US: District of Columbia; US: Maryland
KEYWORDS: aleve; bayerag; drugs; fda; health; heart; medicine; naprosyn; naproxen; nih; pharmaceuticals
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1 posted on 12/20/2004 8:12:43 PM PST by neverdem
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To: neverdem

Well, isn't this special....I have to take 375mg naproxen (prescription) for pain of RA......although I'm only taking it once every other day right now......maybe I should go back to 6-8 aspirin a day instead!


2 posted on 12/20/2004 8:22:57 PM PST by goodnesswins (Tax cuts, Tax reform, social security reform, Supreme Court, etc.....the next 4 years.....)
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To: neverdem

Let`s see...Bill Clinton married to Satan....Bill Clinton needs open heart surgery...


3 posted on 12/20/2004 8:28:01 PM PST by Imaverygooddriver (I`m a very good driver and I approve this message.)
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To: neverdem

There's always Vicodin and Percocet once everything else gets banned. That'd give John P Walters a heart attack though..


4 posted on 12/20/2004 8:31:02 PM PST by AntiGuv ()
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To: goodnesswins

as of 3 hours ago, I quit taking 375 mg naproxen twice daily after nearly 2 years of it. No need for me to discuss it with anyone.

Also, the reason I was switched to it from Motrin is that motrin-Advil-ibuprofen crowds the cox-2 receptor on platelets, preventing the anti-platelet benefit of aspirin. (Feb 03 NEJM, if memory serves)


5 posted on 12/20/2004 8:31:31 PM PST by Vn_survivor_67-68
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To: Vn_survivor_67-68

Soooo....what ARE you taking now? Anything? I'm in PAIN!!! And, at the end of the 48 hours since my last Naproxen.....it's gonna be a REALLY BAD night if I don't take something.


6 posted on 12/20/2004 8:35:00 PM PST by goodnesswins (Tax cuts, Tax reform, social security reform, Supreme Court, etc.....the next 4 years.....)
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To: goodnesswins

I sure hope you don't have to start taking that many aspirin. They are very hard on your stomach. My husband takes Aleve for knee pain and he raves about it. I like it too. I don't think we will stop taking it until they do lots more research that is more definitive. If it turns out that all these NSAIDs are dangerouse I don't know what some people are going to do...lots of people can't take aspirin.

We will remain loyal Aleve users for now.


7 posted on 12/20/2004 8:35:44 PM PST by DestroytheDemocrats (My screen name has come true!!!! W whipped the Dems ! Yaaaaaay!!!)
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To: Vn_survivor_67-68

Discovery of Unexpected Ibuprofen-Aspirin Interaction will Force a Change in Ibuprofen Prescribing
New England Journal of Medicine

A new study published in the December 20, 2001 issue of the New England Journal of Medicine has found that ibuprofen blocks the heart-protecting effects of aspirin.

The study entitled Cyclooxygenase Inhibitors and the Antiplatelet Effects of Aspirin by Francesca Catella-Lawson, M.D and her colleagues concludes: "The concomitant administration of ibuprofen but not rofecoxib, acetaminophen, or diclofenac antagonizes the irreversible platelet inhibition induced by aspirin. Treatment with ibuprofen in patients with increased cardiovascular risk may limit the cardioprotective effects of aspirin."

The study found that when patients took a single dose of ibuprofen beforehand, aspirin lost 98 percent of its blood-thinning power. If aspirin was taken first, three daily doses of ibuprofen eliminated 90 per cent of aspirin's benefit.

The study found show no conflict between aspirin and three other arthritis drugs: rofecoxib, diclofenac, and acetaminophen.


8 posted on 12/20/2004 8:36:28 PM PST by Vn_survivor_67-68
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To: DestroytheDemocrats

Aleve just doesn't do ANYTHING for MY pain. That's the problem....The prescription is a timed release one that seems to help - at least makes some days more bearable. Thanks.


9 posted on 12/20/2004 8:43:30 PM PST by goodnesswins (Tax cuts, Tax reform, social security reform, Supreme Court, etc.....the next 4 years.....)
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To: goodnesswins

I have some percodan. I never thought the Napro did much for me anyway.....OR the Motrin, for that matter.

(from the article above)
:.....federal officials are warning patients not to exceed the recommended dose of two 200-milligram pills a day...."

(you wrote)
I have to take 375mg naproxen (prescription) for pain of RA......although I'm only taking it once every other day right now




You are below the threshold of the gov warning....they say 400mg/day maximum, and you take only 375 every other day.

since it appears effective for you, I think you'd best give your doc a call, though.


10 posted on 12/20/2004 8:45:43 PM PST by Vn_survivor_67-68
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To: Vn_survivor_67-68

LOL...well your post reminds me....I have some codeine hidden away somewhere.....maybe I should pull THAT out!

Thanks.


11 posted on 12/20/2004 8:49:37 PM PST by goodnesswins (Tax cuts, Tax reform, social security reform, Supreme Court, etc.....the next 4 years.....)
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To: Vn_survivor_67-68; El Gato; JudyB1938; Ernest_at_the_Beach; Robert A. Cook, PE; lepton; LadyDoc; ...
Thanks for the citation. Folks taking daily aspirin should take it at least one hour before taking any NSAIDs.

Cyclooxygenase Inhibitors and the Antiplatelet Effects of Aspirin

FReepmail me if you want on or off my health and science ping list. IIRC, rofecoxib was Vioxx.

12 posted on 12/20/2004 9:01:21 PM PST by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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To: neverdem

".....Folks taking daily aspirin should take it at least one hour before taking any NSAIDs."

My understanding was that the anti-platelet interference was ONLY for ibuprofen......and that other NSAIDS were ok in this regard......I STILL think that the paper I read at the time was in the Feb 15, 02 NEJM, despite the piece I posted above.

Anyway, the ibu and napro weren't very effective, so I will just quit it.....I had a ticker-clot in 99, so I will never quit the asa.


13 posted on 12/20/2004 9:10:18 PM PST by Vn_survivor_67-68
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To: neverdem

correction

The paper I read was in Feb15, 03 NEJM....not 02, as I typo'd, sorry


14 posted on 12/20/2004 9:16:00 PM PST by Vn_survivor_67-68
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To: Rightfootforward

Over here. Read post #8


15 posted on 12/20/2004 9:16:02 PM PST by Veto! (Opinions freely dispensed as advice)
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To: neverdem

One word:
A-S-P-I-R-I-N


16 posted on 12/20/2004 9:19:03 PM PST by GOPJ (M.Dowd...hits..like a bucket of vomit with Body Shop potpourri sprinked across the surface--Goldberg)
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To: neverdem

I think I will just stick with Asprin and/or Tylenol.


17 posted on 12/20/2004 9:19:28 PM PST by Chewbacca (Happy Jesus' Birthday to everyone!!!!!)
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To: Vn_survivor_67-68

LANCET.....Feb 15, 2003 (so much for memory, LOL)

Thomas M. MacDonald, M.D., medicines monitoring unit, department of clinical pharmacology and therapeutics, Ninewells Hospital and Medical School, University of Dundee, Scotland; Garrett FitzGerald, M.D., chairman, pharmacology department, University of Pennsylvania, Philadelphia; Feb. 15, 2003, The Lancet

Study Warns of Mixing Ibuprofen with Aspirin
Painkiller combo may spell trouble for heart patients

http://www.hon.ch/News/HSN/511778.html


18 posted on 12/20/2004 9:26:29 PM PST by Vn_survivor_67-68
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To: goodnesswins

I think you ought to take your pain meds as usual and wait and ask your doctor about all these studies coming out.


19 posted on 12/20/2004 9:27:30 PM PST by DestroytheDemocrats (My screen name has come true!!!! W whipped the Dems ! Yaaaaaay!!!)
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To: Vn_survivor_67-68

During the 1990s a hematologist told me that all the NSAIDS reversibly inhibit platelet aggregation. Only aspirin irreversibly inhibits platelet aggregation. Now this with multiple doses of ibuprofen and the effectiveness of aspirin being decreased. IIRC, about twenty percent of folks are aspirin resistant with respect to its cardioprotective effects.


20 posted on 12/20/2004 9:33:12 PM PST by neverdem (May you be in heaven a half hour before the devil knows that you're dead.)
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