FDA issues warning for Naproxen (Aleve)
- Thread starter Frangible
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Skyline
Enlightened
Re: FDA rules Naproxen Sodium (Aleve) dangerous
I'd be careful with the phrasing with which you titled this thread. It's not quite accurate.
They've issued a warning that there may be some risk. If the FDA "ruled" that Naproxen is "dangerous", it'd be taken off the shelves.
My two cents.
I'd be careful with the phrasing with which you titled this thread. It's not quite accurate.
They've issued a warning that there may be some risk. If the FDA "ruled" that Naproxen is "dangerous", it'd be taken off the shelves.
My two cents.
was_jlh
Enlightened
- Joined
- Oct 15, 2002
- Messages
- 751
Re: FDA rules Naproxen Sodium (Aleve) dangerous
Thank you, Frangible, I've been taking too much of it lately due to a tooth problem.
Thank you, Frangible, I've been taking too much of it lately due to a tooth problem.
Re: FDA warns Naproxen users
I too feel that the original title of the thread is misleading. I read the article and did not see where the FDA ruled the drug "dangerous". Let's try not to overstate things here.... /ubbthreads/images/graemlins/wink.gif
I would advise that anyone reading this thread who may have personal concerns, please read the article linked above and then talk to your doctor and/or pharmacist before making any decisions regarding medications that you are currently taking. Self-medicating is ALWAYS a bad idea!!!
I too feel that the original title of the thread is misleading. I read the article and did not see where the FDA ruled the drug "dangerous". Let's try not to overstate things here.... /ubbthreads/images/graemlins/wink.gif
I would advise that anyone reading this thread who may have personal concerns, please read the article linked above and then talk to your doctor and/or pharmacist before making any decisions regarding medications that you are currently taking. Self-medicating is ALWAYS a bad idea!!!
Re: FDA warns Naproxen users
Sorry, but I cannot agree that calling it dangerous is misleading.
From Merriam-Webster:
Main Entry: dan·ger·ous
Pronunciation: 'dAn-j&-r&s; 'dAn-j&rs, -zhr&s
Function: adjective
1 : exposing to or involving danger
2 : able or likely to inflict injury or harm
- dan·ger·ous·ly adverb
- dan·ger·ous·ness noun
synonyms DANGEROUS, HAZARDOUS, PRECARIOUS, PERILOUS, RISKY mean bringing or involving the chance of loss or injury. DANGEROUS applies to something that may cause harm or loss unless dealt with carefully <soldiers on a dangerous mission>. HAZARDOUS implies great and continuous risk of harm or failure <claims that smoking is hazardous to your health>. PRECARIOUS suggests both insecurity and uncertainty <earned a precarious living by gambling>. PERILOUS strongly implies the immediacy of danger <perilous mountain roads>. RISKY often applies to a known and accepted danger <shied away from risky investments>.
I don't know how you guys define "dangerous", but it seems to meet every definition of the word.
Sorry, but I cannot agree that calling it dangerous is misleading.
From Merriam-Webster:
Main Entry: dan·ger·ous
Pronunciation: 'dAn-j&-r&s; 'dAn-j&rs, -zhr&s
Function: adjective
1 : exposing to or involving danger
2 : able or likely to inflict injury or harm
- dan·ger·ous·ly adverb
- dan·ger·ous·ness noun
synonyms DANGEROUS, HAZARDOUS, PRECARIOUS, PERILOUS, RISKY mean bringing or involving the chance of loss or injury. DANGEROUS applies to something that may cause harm or loss unless dealt with carefully <soldiers on a dangerous mission>. HAZARDOUS implies great and continuous risk of harm or failure <claims that smoking is hazardous to your health>. PRECARIOUS suggests both insecurity and uncertainty <earned a precarious living by gambling>. PERILOUS strongly implies the immediacy of danger <perilous mountain roads>. RISKY often applies to a known and accepted danger <shied away from risky investments>.
I don't know how you guys define "dangerous", but it seems to meet every definition of the word.
greenLED
Flashaholic
Re: FDA warns Naproxen users
Bottomline: *Under certain circumstances* (important in any experiment or study to know the population your trying to infer about), if you take Naproxene, a person is "50 percent more likely to have heart attacks or strokes.". In my mind, that is dangerous and scary *if* you are taking this med. If you're not taking it, it's good to have been warned. Thanks for the heads up.
Afterthought:
Let's not get tied up in semantics, guys. Frangible, I don't think the issue here is whether Naproxene is dangerous or not. The issue Sasha and Skyline raise is that this thread's title is "FDA rules...". The CNN article says FDA "issued a warning...". Your interpretation of an FDA earning obviously is different from other people's. I don't want to guess whether a "warning"="ruling" so I'll let you guys sort it out. So, I agree with both sides /ubbthreads/images/graemlins/grin.gif and will let people read the article and decide for themselves.
Bottomline: *Under certain circumstances* (important in any experiment or study to know the population your trying to infer about), if you take Naproxene, a person is "50 percent more likely to have heart attacks or strokes.". In my mind, that is dangerous and scary *if* you are taking this med. If you're not taking it, it's good to have been warned. Thanks for the heads up.
Afterthought:
Let's not get tied up in semantics, guys. Frangible, I don't think the issue here is whether Naproxene is dangerous or not. The issue Sasha and Skyline raise is that this thread's title is "FDA rules...". The CNN article says FDA "issued a warning...". Your interpretation of an FDA earning obviously is different from other people's. I don't want to guess whether a "warning"="ruling" so I'll let you guys sort it out. So, I agree with both sides /ubbthreads/images/graemlins/grin.gif and will let people read the article and decide for themselves.
Draco_Americanus
Enlightened
Re: FDA warns Naproxen users
The question I have is if the said person is 50% more likely to have heart/ stroke problems, what is the 50% of ?
what are the odds based on?
if say a "normal" person has the odds of a stroke set at 1 out 50,000 for a 45 year old human male(spec pulled from My diaper as I don't know what that acual number is,) then if that person took this drug all the time his odds would then be 1 in 25,000 ?
sometimes the level of pain a person may have, may be worth the risk.
I now fear that a lot of pain sufferers may lose a medication that works better then other medications with out thier voice being heard.
The question I have is if the said person is 50% more likely to have heart/ stroke problems, what is the 50% of ?
what are the odds based on?
if say a "normal" person has the odds of a stroke set at 1 out 50,000 for a 45 year old human male(spec pulled from My diaper as I don't know what that acual number is,) then if that person took this drug all the time his odds would then be 1 in 25,000 ?
sometimes the level of pain a person may have, may be worth the risk.
I now fear that a lot of pain sufferers may lose a medication that works better then other medications with out thier voice being heard.
was_jlh
Enlightened
- Joined
- Oct 15, 2002
- Messages
- 751
Re: FDA warns Naproxen users
Draco, it was a 50% increase over the group taking the placebo.
Draco, it was a 50% increase over the group taking the placebo.
hank
Flashlight Enthusiast
Re: FDA warns Naproxen users
This is interesting partly because it gives the lie to Merck's claims in 2000:
"Merck found in 2000 that more than twice as many patients had heart attacks when taking Vioxx than when given an older painkiller, naproxen. But it made the argument that the difference was due to protective effects of naproxen, not to a problem with Vioxx...."
[Merck had no evidence to back this claim -- they made it up, it was "arguable", as in, what could we argue that, if true, would explain these excess heart attacks in people who use Vioxx compared to those using naproxen ....]
That rhetorical lawyer trick worked-- Merck kept Vioxx on the market (and kept advertising it to consumers) for the four years between 2000 and 2004.
Being without relief for pain is itself a major health rish -- this isn't easy or simple as an issue. But having honest research done, published, reviewed and replicated is fundamental to making good decisions.
It's kind of like buying LEDs -- any individual problem is just an individual's problem. A pattern, good statistics, and good process control allows figuring out what makes a difference and what it will cost to improve the results overall, as well as how to price the individual items properly when they're sold according to the quality of the 'bin' result. Medicines need to be tested the same way.
This is interesting partly because it gives the lie to Merck's claims in 2000:
"Merck found in 2000 that more than twice as many patients had heart attacks when taking Vioxx than when given an older painkiller, naproxen. But it made the argument that the difference was due to protective effects of naproxen, not to a problem with Vioxx...."
[Merck had no evidence to back this claim -- they made it up, it was "arguable", as in, what could we argue that, if true, would explain these excess heart attacks in people who use Vioxx compared to those using naproxen ....]
That rhetorical lawyer trick worked-- Merck kept Vioxx on the market (and kept advertising it to consumers) for the four years between 2000 and 2004.
Being without relief for pain is itself a major health rish -- this isn't easy or simple as an issue. But having honest research done, published, reviewed and replicated is fundamental to making good decisions.
It's kind of like buying LEDs -- any individual problem is just an individual's problem. A pattern, good statistics, and good process control allows figuring out what makes a difference and what it will cost to improve the results overall, as well as how to price the individual items properly when they're sold according to the quality of the 'bin' result. Medicines need to be tested the same way.
Re: FDA warns Naproxen users
[ QUOTE ]
I now fear that a lot of pain sufferers may lose a medication that works better then other medications with out thier voice being heard.
[/ QUOTE ]
You can still use it, according to the FDA, as long as you follow the directions not to use it for more than 10 days.
Perhaps aspirin or advil might be an acceptable long-term alternative?
[ QUOTE ]
I now fear that a lot of pain sufferers may lose a medication that works better then other medications with out thier voice being heard.
[/ QUOTE ]
You can still use it, according to the FDA, as long as you follow the directions not to use it for more than 10 days.
Perhaps aspirin or advil might be an acceptable long-term alternative?
mattheww50
Flashlight Enthusiast
Re: FDA warns Naproxen users
This is a far more complex problem then the FDA is letting on. I suspect when the smoke clears, it is going to be discovered that is a problem with just about all Non-
Steroidal Anti Inflamatory Drug. (NSAIDS)Nobody has talked about an avoidance, but I suspect there is one, 81 mg of asprin per day.
The bind is to really establish that these drugs are the cause, you need a double blind study over a long time, and no ethics committee is ever going to allow that to happen.
How do you justify knowingly giving placebos to people who are clearly in pain for a long time. you cannot, so you are forced to make comparisons against other drug treatments.
With vaccines it is a different story. For example with the Hep A and Hep B vaccines, there was no prior product, ergo it was a comparison between the vaccine and no vaccine, and since there was no previous vaccine, the people not getting the vaccine were no worse than the general public. Witholding treatment when known, and effective and safe treatment is readily available runs into intractable ethics problems, and the ethics committes that approve human trials won't allow it, period.
The bind comes in because if people aren't taking Ibuprofen,
Naproxen,Acetominophen or a COX2 inhibitor, they are probably taking something else, Asprin, which is well established for its anti-platlet aggregation effects, which prevent heart attacks and strokes! That fact is well established from multiple clinical trials.
So My gut feel is that these drugs don't actually cause an increase in Heart Attack and Stroke, it is far more likely that the alternative (Asprin) is preventing them!
It s kind of like is the road underwater because the water rose, or the land fell, We always assume it was the water that came up, that isn't necessarily the case.
This is a far more complex problem then the FDA is letting on. I suspect when the smoke clears, it is going to be discovered that is a problem with just about all Non-
Steroidal Anti Inflamatory Drug. (NSAIDS)Nobody has talked about an avoidance, but I suspect there is one, 81 mg of asprin per day.
The bind is to really establish that these drugs are the cause, you need a double blind study over a long time, and no ethics committee is ever going to allow that to happen.
How do you justify knowingly giving placebos to people who are clearly in pain for a long time. you cannot, so you are forced to make comparisons against other drug treatments.
With vaccines it is a different story. For example with the Hep A and Hep B vaccines, there was no prior product, ergo it was a comparison between the vaccine and no vaccine, and since there was no previous vaccine, the people not getting the vaccine were no worse than the general public. Witholding treatment when known, and effective and safe treatment is readily available runs into intractable ethics problems, and the ethics committes that approve human trials won't allow it, period.
The bind comes in because if people aren't taking Ibuprofen,
Naproxen,Acetominophen or a COX2 inhibitor, they are probably taking something else, Asprin, which is well established for its anti-platlet aggregation effects, which prevent heart attacks and strokes! That fact is well established from multiple clinical trials.
So My gut feel is that these drugs don't actually cause an increase in Heart Attack and Stroke, it is far more likely that the alternative (Asprin) is preventing them!
It s kind of like is the road underwater because the water rose, or the land fell, We always assume it was the water that came up, that isn't necessarily the case.
Re: FDA warns Naproxen users
[ QUOTE ]
Frangible said:
Perhaps aspirin or advil might be an acceptable long-term alternative?
[/ QUOTE ]
Advil isn't home free either.
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.
[ QUOTE ]
Frangible said:
Perhaps aspirin or advil might be an acceptable long-term alternative?
[/ QUOTE ]
Advil isn't home free either.
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.
Re: FDA warns Naproxen users
Interesting topic since I use to take both suspect drugs in addition to 11 others. I was taking two celebrexs a day, 2 anti inflimation pills, muscle relaxers and pain patches not to mention tylenol #3. I found vioxx did little to nothing for me. Celebrex worked, but I needed at least 2 a day, where the dose was one. I also found I needed indomedenson(SP?) for my back and should pain while ketporofin(SP?) for my neck pain. Later found out I could not take all those a day, only one of the other and if celebrex, one a day.
Ultimately I found better relief in androbolic steroids you can guy at most viatmin stores and protein shakes. I had several doctors and each one had a different opinion on the doses.
I also was told aleve was a safe alternative to celebrex and used it when I couldnt afford celebrex. Boy looks like they may be wrong.
Anyway, last I heard more folks die from non steroid type pills than aids in america. Thats a shock to me. I assumed aids was much worse than those in pain.
Interesting topic since I use to take both suspect drugs in addition to 11 others. I was taking two celebrexs a day, 2 anti inflimation pills, muscle relaxers and pain patches not to mention tylenol #3. I found vioxx did little to nothing for me. Celebrex worked, but I needed at least 2 a day, where the dose was one. I also found I needed indomedenson(SP?) for my back and should pain while ketporofin(SP?) for my neck pain. Later found out I could not take all those a day, only one of the other and if celebrex, one a day.
Ultimately I found better relief in androbolic steroids you can guy at most viatmin stores and protein shakes. I had several doctors and each one had a different opinion on the doses.
I also was told aleve was a safe alternative to celebrex and used it when I couldnt afford celebrex. Boy looks like they may be wrong.
Anyway, last I heard more folks die from non steroid type pills than aids in america. Thats a shock to me. I assumed aids was much worse than those in pain.
geepondy
Flashlight Enthusiast
Re: FDA warns Naproxen users
Good lord, ibuprofen has been my godsend. Under prescription for a few injuries, I have taken up to 2800 mg a day (equivalent of 12 advils) and will take two to four tablets for a really bad headache and when hiking will take 800 mg prior for "preventive" measure to quell my aching knee and will often take another four to eight hundred mg during a particular long hike. I don't take the stuff every day and indeed go weeks without taking it but I sure would be disappointed if it was taken off the market.
Good lord, ibuprofen has been my godsend. Under prescription for a few injuries, I have taken up to 2800 mg a day (equivalent of 12 advils) and will take two to four tablets for a really bad headache and when hiking will take 800 mg prior for "preventive" measure to quell my aching knee and will often take another four to eight hundred mg during a particular long hike. I don't take the stuff every day and indeed go weeks without taking it but I sure would be disappointed if it was taken off the market.
flashlight_widow
Enlightened
Re: FDA warns Naproxen users
I occasionally take Naproxen or Ibuprofen for bursitis in my left hip, because both are anti-inflammatories. I might take 1 pill a month - IF that. At the rate that I consume it, I'm not going to worry my pretty little head about it. I do hope they don't pull anything from the market, though.
I occasionally take Naproxen or Ibuprofen for bursitis in my left hip, because both are anti-inflammatories. I might take 1 pill a month - IF that. At the rate that I consume it, I'm not going to worry my pretty little head about it. I do hope they don't pull anything from the market, though.
Alan_L
Newly Enlightened
Re: FDA warns Naproxen users
I worked for the company that made Naproxen before it was sold to Bayer to market over the counter, so I know a little about this drug. If you read the CNN article and the linked related article closely, the finding of greater cardiovascular events came from a study to see if Naproxen could be used to treat Alzheimer's, not pain relief which is what the drug was designed for. Also, the patients were 70 years old or older and had been taking the drug regularly for 3 years and were supposed to take it for 2 more years. Normally pain relief drugs are taken until the pain is gone and not on a continuous basis. Older people are already at risk of heart attacks and if you take a drug in a way that it wasn't approved for, then the chances of new adverse effects that haven't been seen before are pretty high.
Naproxen went OTC about 10 years ago and has been on the market as a prescription drug for about 30 years. I think if there was a significant heart attack risk to the general public, it would have shown up by now. If they want to know if Naproxen causes heart attacks when it is used as directed, then there needs to be a study done for that specific purpose, not as a side effect of a study using the drug in new ways.
I worked for the company that made Naproxen before it was sold to Bayer to market over the counter, so I know a little about this drug. If you read the CNN article and the linked related article closely, the finding of greater cardiovascular events came from a study to see if Naproxen could be used to treat Alzheimer's, not pain relief which is what the drug was designed for. Also, the patients were 70 years old or older and had been taking the drug regularly for 3 years and were supposed to take it for 2 more years. Normally pain relief drugs are taken until the pain is gone and not on a continuous basis. Older people are already at risk of heart attacks and if you take a drug in a way that it wasn't approved for, then the chances of new adverse effects that haven't been seen before are pretty high.
Naproxen went OTC about 10 years ago and has been on the market as a prescription drug for about 30 years. I think if there was a significant heart attack risk to the general public, it would have shown up by now. If they want to know if Naproxen causes heart attacks when it is used as directed, then there needs to be a study done for that specific purpose, not as a side effect of a study using the drug in new ways.
