Pain Drug Naproxen Poses Heart Risk, U.S. FDA Says
- 12-20-2004, 08:44 PM
Pain Drug Naproxen Poses Heart Risk, U.S. FDA Says
WASHINGTON (Reuters) - The U.S. Food and Drug Administration on Monday issued a warning to patients taking the painkiller naproxen after a government study showed the over-the-counter medicine can cause an increased risk of heart problems.
Patients taking naproxen, which is sold as a generic drug and under the brand names Aleve, Naprosyn and others, should not exceed the recommended dose and should not take it for more than 10 days unless directed by their doctor, the FDA said in a statement.
The news follows studies showing increased heart risks in two prescription painkillers. Merck & Co. Inc. withdrew its arthritis drug Vioxx in September. Pfizer Inc. has kept its arthritis medicine Celebrex on the market, but has suspended consumer advertising.
The results were part of a National Institutes of Health trial studying certain anti-inflammatory drugs in patients at risk for Alzheimer's disease. The trial, which included Celebrex, was halted after early results showed a higher risk of cardiovascular problems.
Celebrex showed "no significant increase" in risk for cardiac trouble or stroke in the trial, the NIH said.
Bayer AG makes Aleve, and Roche Palo Alto, a subsidiary of Roche AG, makes Naprosyn.
Naproxen and Celebrex are in a group of drugs called nonsteroidal anti-inflammatory drugs that includes aspirin and ibuprofen. Within that group, Vioxx and Celebrex are part of a class known as Cox-2 inhibitors, along with Pfizer's Bextra.
- 12-21-2004, 10:42 AM
Of course..The one and only drug I take that works for me.I just can't win.
Ps: thanks for hooking me up Bobo..
- 12-21-2004, 03:27 PM
I know--it's the only pain drug that works for me, too! That's why this article caught my attention. They bolded part is key though--probably no worries unless taken over 10 days straight or above dosages.
12-22-2004, 12:02 AM
I'm in the same boat as you guys. I love Aleve as it works very well for me. I had a headache for the past day and refused to take it after this news came out. Advil gel caps works for me, just not a well.
12-23-2004, 05:11 PM
You know, EVERYTHING is dangerous in excess. Abuse leads to negative side effects.
Maybe penecillin should be banned? My grandfather almost died from a relatively low dose of it! I mean yea it helps the many but think of those who are allergic!!!!
Also be careful with Advil, if you take too many you'll destroy your stomach lining or something.
12-25-2004, 11:09 AM
not to mention if you take a bucketful of asipirn it'll give you ulcers...and if you take enough of it you'll croak. They'll ban aspirin next.Originally Posted by Talon
12-25-2004, 11:12 AM
There is another otc nsaid called Orudis that works really well for me. The only place I can get it here is at Wal Mart...about $8 for a 100 tab supply. You might give it a try.Originally Posted by MaDmaN
Usually in these studies the amount it takes to bring on the increased risks is way more than you would ever take, even if you upped the dosage. And as others pointed out anything taken to excess isn't a good thing....
01-12-2005, 09:25 AM
May allay some fears.
http://www.medscape.com/viewarticle/496593 Might have to register. Full Text:
NEW YORK (Reuters) Dec 23 - Warnings that taking Bayer AG's Aleve painkiller increases heart risks may have been exaggerated, according to some medical experts, the Wall Street Journal reported on Thursday.
The U.S. Food and Drug Administration warned earlier this week of heart risks connected to the over-the-counter painkiller naproxen, which is sold as a generic and under several brand names, including Aleve.
The risk that the drug could cause heart attacks was "not really" statistically significant, John Breitner, a researcher at the University of Washington, Seattle, who led the study comparing Aleve, Pfizer Inc.'s Celebrex and a placebo in the prevention of Alzheimer's, told the newspaper.
Breitner added that only two or three patients who took either naproxen or the placebo died from a heart attack and none of them died from a stroke, according to the Journal.
A spokesman for Bayer Healthcare told Reuters the company had no comment on the study because "we have not yet seen the final data to make our evaluation."
The study was not halted because of any concerns over increased heart risks, the Journal said.
In fact, the paper reported that the study was halted because the patients, concerned especially about news of other drugs being linked to heart problems, began to refuse taking their medicine, according to Susan Molchan, director of the Alzheimer's disease clinical trials program at the National Institute of Health's National Institute on Aging.
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