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FDA Considers Banning Acetaminophen-Based Pain Killers
Greg George writes "The FDA has determined that Tylenol enhancing pain killers are dangerous enough to potentially be pulled from the market. Drugs including Vicodin, Hydrocodone, Lortab, Maxidone, Norco, Zydone, Tylenol with codeine, Percocet, Endocet, and Darvocet may be permanently banned from the US market, even if the patient has a prescription from a doctor. The problem is the key ingredient — acetaminophen — can easily damage or destroy a patient's liver if more than 2000 mg are used per day. In many cases that means if you take a pain killer and then take two extra strength Tylenol, you may have gone over the maximum dosage per day."
Would it not make more sense to educate the people taking the pills, instead of banning an effective pain reliever? Anyone taking a vicodin and then two Tylenol is either in serious pain that the hydrocodone is not treating, or is unaware of what is in vicodin. A little talk by the pharmacist or doctor can fix both. Lowering the dose of APAP in prescription pills makes sense too, I mean 650mg in Darvocets? Take that 4 times a day and you are already over the daily dose. All of that just to prevent some junkies from getting high?
Not that I will argue too much, since I can't take Aspirin or ibuprofen, it will be much easier to get a script for pure codeine.
The problem is with the idiots that take 1000mg and then cant wait for it to work so they take another 2-4 in an hour or so.
The people that are stupid and dont read the bottle that says" DO NOT TAKE MORE THAN XXX in a 24 hour period." It's clear as day on the fricking bottle.
So we ban something because the average person is too stupid to read the bottle?
Can we ban water as well? if you drink 6 gallons in an hour it will kill you!
Do not look at laser with remaining good eye.
The FDA made the drug companies put acetaminophen into the narcotic painkillers to keep people from recreationally overdosing on them (same as they "denature" ethyl alcohol that you can buy at the hardware store by poisoning it with methyl alcohol), and then when druggies take large doses anyway and cause liver damage and death, the FDA is *surprised*?
So when will the FDA ban alcohol for destroying people's livers?
Seriously here. Why not make sure that there are STRONG WARNINGS on these drugs and require that they also place the warnings on TV Ads (not just in the small print, but actually required spoken warning about exceeding the 2000mg limit, and mention that other drugs like prescription pain killers may also contain this substance and to check with your doctor). I mean, if people know that over-dosing on this WILL seriously damage and potentially kill your liver, they will pay a little more attention to how much they are taking...
As it currently is, with the current ads and warnings, more people think that something like Tylenol with Codeine is pretty safe to take. I mean, its Tylenol, safe for your stomach (too bad just not necessarily safe for your liver).
We were all warned a long time ago that MS products sucked, remember the Magic 8 Ball said, "Outlook not so good"
But if you take drugs as correctly prescribed, you can, and should, have both. In spite of the hysteria, people have taken vicodin for pain and not died from liver failure.
One problem with the substance is that the doses in which it's effective are so close to the doses in which it's toxic, as mentioned.
The other problem is that you can take a fatal overdose, and you'll be fine for three days. Then you die very horribly indeed.
A lot of the time a suicide attempt is the proverbial "cry for help". Someone overdosing on acetaminophen might take their overdose and fall asleep in a tearful puddle, feel emotionally purged and a lot better in the morning. And then discover a few days later that they are the walking dead.
Most other drugs have the virtue of making you feel ill enough to seek (or attract) medical attention. Some of them you can just literally "sleep off", with enough support.
That said, it's an excellent drug. Safe, when taken as prescribed, very few side effects, and effective, as evidenced by the enormous number of combination preparations containing it - it reduces the overall dose of opiates that need to be taken and that's a good thing.
The downside of this profligate mixing with other drugs of course, is that if you're not 100% clued up on which preparations you are taking, you might take an overdose.
I'm an ex-doctor. I had no idea that Vicodin contained it until I read TFS. I've never prescribed the stuff though. If I was living in blissful ignorance every time Greg House popped a little blue pill, imagine what the general level of knowledge is amongst Joe Public.
The tinfoil-hatted part of me thinks that they only mix acetaminophen with opiates to stop junkies abusing them anyway. Who'd be stupid enough to take a fatal overdose of something that doesn't even get you high ... oh , wait, the general public, after we spent so much time and effort dumbing them down...
Maybe your sister should have told you not to drink that much alcohol in first place. Makes a lot of more sense that way.
"It's such a fine line between stupid and clever" -- David St. Hubbins, Spinal Tap
I'm a Type II diabetic. One of the medications I take for it is glypizide, which increases my insulin production, lowering my blood glucose level. If I took too many, my bg would get so low I'd pass out and possibly die. Does that mean it should be banned? No, of course not; it means that I'm given instructions on how much to take and when, and I follow those instructions. Give patients using these drugs instructions that include not taking other, non-prescription pain killers with them (or listing which ones are safe, and in what dose) and trust them to do as they're told. Most people will follow that type of doctor's orders, especially if it's explained why and it's not just an arbitrary order. And don't point out that some people aren't smart enough to understand, either, because it's the people who are smart enough to "know better" that are the problem. The "left side of the bell curve" is more likely to do what they're told because they understand that they don't know better.
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Of course, instead of the intended effect of less drug abuse, we now have more liver failures, at a higher societal cost. This is the same thinking that has people opposed to clean needles programs - does less clean needles mean people will inject less? No, actually they will still inject, and they will have a higher chance of contracting Hepatitis or HIV.
Hands in my pocket
This actually happened to me. A few years back I had open heart surgery. After spending a week in hospital, I was released with a big fat percocet prescription (having your sternum in 2 halves is remarkably painful). I was told to "try" to get by on Tylenol, but to take the percocet if the pain was too much. Funny thing about narcotics...it's pretty easy to forget how many and exactly WHEN you last took the medication. In 3 days, I managed to completely shut down my liver by taking two percocets every 4-6 hours. Back into hospital I went and it took about a week for my liver to "wake up." It could have just as easily failed permanently and resulted in my eventual death.
The doctors and nurses who were responsible for prescribing the medication did a lot of finger pointing about WHO should have let me know about the risk of hepatic failure, but the end result was "you should have known better." I'm a programmer, not a doctor...for fook sake.
Also, as someone else mentioned, it is remarkably easy to destroy your liver when you consume alcohol along with acetaminophen. That should be a big bold warning on the label, not fine print.
Best,
Which is really pretty damn fucked up, if you think about it.
Adding an agent that can, and does, cause liver failure and unpleasant death, just to discourage recreational narcotics use, reflects a pretty disturbing set of priorities. Given that recreational narcotics use isn't wildly healthy to start with, it should be able to discourage rational actors without added acetaminophen(and, if it isn't actually that dangerous, why restrict it?). Adding it basically amounts to displaying a willingness to kill drug users, along with people too sick or old to read a bunch of warning labels and cross-check for potential drug interactions. Srsly. WTF?
Most people have no idea what the maximum safe dosage of acetaminophen is. And even if they do, the point is that it's easy to take your vicodin prescription and then take some Nyquil without realizing that Nyquil has acetaminophen as well. The average person is not a pharmacist, and really shouldn't be expected to be one.
When I had surgery on my hand my doctor's instructions for frequency of use on the vicoden would have put me over the 4000mg limit. The pharmacist told me I needed to make sure I only took 5 a day instead of 6 (or something like that, can't quite remember what the frequency was anymore).
Now imagine my doctor had written the prescription correctly for 5 doses a day. There's no reason for most people to know the maximum daily dose value. It would have been quite easy to take the maximum dosage just on pain pills, then take a few doses per day of some OTC med (maybe something for allergies) that lists acetaminophen in the small print and exceed the max dose by quite a bit. Nyquil Sinus for example has 650mg per dose and allows up to 6 per day. Accidentally exceeding 4000mg would be easy.
my wife sees it all the time - dead livers. The concern isn't for people taking this on prescription. They can get a different preparation if necessary. Good riddance. Better yet, get rid of the whole prescription regime. Many doctors are sick of being the narcotic gate keeper. On one side is the DEA looking to pull your license and prosecute, on the other a patient who may or may no be in pain. It's the doctors responsibility to correctly identify drug seekers. Chronic pain rarely kills. What would you do if your livelihood could be taken away for prescribing narcotics to a patient who you believed to be in pain, but was a very clever junkie? I have a feeling there are a lot of chronic pain sufferers that aren't having their pain managed correctly because their physician fears being accused of over prescribing narcotics. More senseless shit brought to you by the War on Drugs. As the late but not so great Bill Hicks said - it's not a war on drugs, it's a war on personal freedom.
46 & 2
Out of curiosity, where exactly do you draw the line between "stupidity", which should be allowed to suffer, and unsafe products? All humans have finite cognitive capacity, finite reflexes, finite short and long term memory, finite rationality under emotional conditions, etc. Further, levels of those capabilities differ between individuals in a given population. Virtually any product could be made more or less safe by changing the design choices, and more or less safe by the degree to which the operator follows directions. Further, some sets of directions are more likely to be followed than others(either because they are onerous and people are lazy, or because they demand precision and people make mistakes). How often does a set of directions have to be not followed before we describe it as "unrealistic" rather than the people not following it as "stupid"?
In this case, assuming suitable labeling, "stupidity" implies possession of fairly low cognitive capacity(for label cross checking) and/or memory(for tracking pills taken over time). Sounds an awful lot like, for instance, the sicker, more arthritic old people who, as a population, probably suck down painkillers and anti-inflammatory drugs like nobody's business.
Obviously, product safety is a matter of degree, with the obviously absurd on one end, and the self-evidently necessary on the other. Navigating the middle, though, is far from obvious. Do you have a particular reason for assigning this case to the "obviously absurd" end of the pool, or is it just a gut reaction?
Do not welcome our nannystate overlords.
Seriously why do we have to keep legislating everything.
When did the FDA become a legislative body? Did I miss that?
The FDA can schedule drugs, so they can decide whether or not I'll get locked in a cage for putting a particular substance in my body. I don't think the term "legislating" is too far off.
Soon after Government run healthcare they are going to tell you want you can and can't eat.
And yet in countries with publicly funded health care the government doesn't do that. It's almost as if your comment is just plain bullshit.
And yet in the US one of the main reasons for taxing tobacco and alcohol is to reimburse Medicare, so a logical conclusion is to tax "bad" food once the State is responsible for everyone's health care. Hell, trans fat is banned in some local jurisdictions so I could see banning other food substances in the future.
What I haven't seen mentioned yet are the differing prescription requirements for the various drugs mentioned. Hydrocodone "compounds" like the ones mentioned can be prescribed by a much larger class of professionals than can straight Hydrocodone/oxycodone/etc.
As the GP stated, the acetaminophen is put in the pills to reduce the "abuse potential" Since these are considered "less dangerous" (since they'll kill you before they get you very high.) the gov't lets them be given out more easily. So right now my dentist can prescribe Vicodin/etc. after a particularly nasty root canal, but if they take it off the market, he can't just write a script for the controlled substance part of the compound on its own.
The problem is, the lethal dose is very close to the effective dose. In addition, the effect of an overdose is not getting sick, its death. It is not a drug that should be sold over the counter. It is simply not safe.
To compound that, it is being misused. It is being mixed with opiates to prevent people overdosing for kicks on the opiates, by mixing the opiates with a substance which is lethal if too much is taken. This is a misuse of Acetaminophen, it is not being compounded with the opiates for the therapeutic effect, but for social purposes to do with our attitudes to opiate abuse.
Something similar happened in the UK with cough mixture. Everyone, pharmacists and doctors, knows that the only effective cough suppressant is codeine. However, in the mania about stopping abuse of codeine based cough syrups, it is sold either mixed with other positively harmful ingredients or not at all. In Gee's Linctus, for example, an optium extract is sold mixed with Quill, which is a truly noxious substance and one of the worst things to give to an invalid.
We need to do a few things. One is to focus more on getting the opiates to people who are sick, stop worrying about people who are sick and need them abusing them. They will not. This implies that if people need opiates, prescribe the things to them, not mixed with crap they do not need. The second thing is we do have to have a rational drug policy which prevents the crime and disease associated with opiate abuse - but what we do not need is to screw up sick people's access to drugs they need in the name of doing this. Not that it does it, anyway.
The third is we need to take Acetaminophen off the over the counter list altogether.
If a doctor wishes to prescribe a mixture of opiates and Acetaminophen, that's a professional decision. There is no reason why Acetaminophen despite its dangers should not be available on a prescription basis, it may have unique applications. But there is every reason why a drug with those characteristics, and to which there are perfectly good over the counter alternatives, should not be sold over the counter, let alone mixed in half the over the counter pain relief and cold remedies.
We should not be telling people to read the ingredients and not take two over the counter pain or cold remedies at the same time under danger of dying. That is just a totally ridiculous, even criminal policy. We should be making sure that any painkiller ingredient where taking two medicines with it in at once will kill you, is not freely available over the counter.
I left hospital recently with a huge stock of this crap - opiate pain relief mixed with Acetaminophen, with the recommended daily dose right at the limit of how much Acetaminophen you can safely take. I got myself off the stuff as fast as possible at the price of feeling some pain. It was a choice I should not have had to make.
How about we leave it as it is, and let people read the warning labels.
I'm tired of not being able to get a decent decongestent because of some stupid war on drugs, and now the ONLY thing that works on my headaches might be banned? Fucking enough already.. if you're too dumb to know you can even pop over the counter pills without thinking, maybe you should die of liver failure.
While what you say is true, aspirin has the same synergistic effects with oral opiates as acetaminophen, and is equivalent in terms of antipyretic and anti-inflammatory action as well. However it has a much wider margin between therapeutic level and destructive overdose level, and since overdosing usually causes tinnitus (ringing in the ears) long before any permanent damage is done, it comes complete with an audible overdose warning system.
So there is not, and has never been, a valid reason for creating acetaminophen based competitors to the aspirin based compounds that were prevalent before 1980. Such as Emperin #3 (replaced by Tylenol #3), APC, APC with Codeine, and so on.
The problem with aspirin in this regard is that about three decades ago several marketing campaigns were pushing Tylenol products by putting undue emphasis on aspirin sometimes causing stomach distress in some people. This was before it was known that stomach ulcers were caused by a bacterial infection, and it was easy to suggest that too much aspirin could be causing some ulcers.
The modern American health care industry is riddled with these kinds of bullshit pharmaceutical fads. "We'll do anything for a buck" seems to be the motto.
Aspirin isn't without its own problems. High doses for an extended period of time can lead to long clotting times, for instance. But on the whole, it is a whole lot safer than acetaminophen. It just isn't as profitable.
Will