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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."
As long as it doesn't cause Lupus...
I'm sure "SlashdotMedia" will improve on all the wonders that Dice Holdings blessed us all with
Before everyone screams bloody murder, the fact remains that you'll still be able to buy the stuff, separately. Percocet, for example, is actually a mix of oxycodone and acetaminophen. You can buy them separately as Oxycontin and Tylenol (or paracetamol in the UK).
It's the combination that causes problems; people wind up overdosing. Overdosing on the oxycodone portion is not all that dangerous (you could swallow 2 dozen of them at once though I would definitely not recommend it) compared to Tylenol, which can damage your liver. Thirty extra-strength tylenols at once can destroy your liver and you'll die within 72 hours. These medications have acetaminophen in them as an an anti-inflammatory to work with the painkiller, but they wind up being the deadlier part of the drug since people take too much. A few people think they can commit suicide by swallowing the whole prescription, but what happens is the codeine-based painkiller part wears off in hours and then the agonizing abdominal pain of liver failure begins until they're dead 3 days later.
You'll still be able to buy the separate ingredients, hydrocodone is Vicodin and Norco, oxycodone is Percocet, etc. There are other formulations; Percodan is nearly the same as Percocet except it uses aspirin in place of acetaminophen (Tylenol)
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.
Disclaimer: Not a doctor or med student but my three sisters are nurses/researchers.
My older sister warned me when I started college that if I was going to drink I should avoid acetaminophen at all costs. Luckily, I don't get headaches or have had a need for a painkiller in a very long time and I think it's been about six years since I've taken them. If you are a heavy drinker, avoid acetaminophen as your liver's already dealing with the alcohol and crap in the American diet and doesn't appreciate it. My sister told me that people who use acetaminophen during hangovers may be putting themselves at a much higher risk for liver diseases. I'm a little concerned these have been out for this long when there's safer alternatives. I'm sure the companies that stand to profit have tons of tricks up their sleeves yet.
My work here is dung.
Which is why my doctor tells me not to take any medication containing acetaminophen other than those prescribed, and the form I have to sign when I pick my prescriptions repeats that warning.
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.
All this ban is saying is that you can't buy the drugs as an all-in-one formulation. You can still buy them just the same as separate pills.
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*?
... good.
My prescription is 7.5mg hydrocodone, 500mg acetaminophen (standard - though there are a few variations on the amount of hydrocodone). The FDA has enforced that amount of acetaminophen, for two reasons. Hydrocodone is relatively addictive, and acetaminophen often induces a huge amount of nausea. This acts as a deterrent for anyone trying to "get high" off of the hydrocodone. Second, acetaminophen is a pretty decent pain killer, which hey, if you're taking lortab, that is the whole point.
My problem is the raw nausea induced. It's not uncommon for me to need to take one, and then develop a severe stomach, erm, 'problem' to the point where I can't do anything until a couple minutes after I've emptied my stomach into the nearby toilet. That is solely a side effect of the acetaminophen.
The "hey my liver is going to live" is a bonus effect from the removal of acetaminophen as far as I'm concerned.
The problem of course - is what they'd replace the acetaminophen with, should they want to continue shipping lortab (and friends). I somehow doubt it'd be any better in terms of side effects.
But I can hope.
So does House still have a working liver at this point?
The whole reason he got into medicine in the first place was to be near a supply of fresh new organs. It was ether THAT or start APPLE and he just couldn't stomach the idea of rampant fanboys.
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?
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.
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.
Even though I was concerned about taking the maximum daily limit of vicodin and then percocet, my doctors dismissed my concerns as all they really care about is treating my spine/nerve damage. Well now that my pre-surgery tests show that my enzyme levels were high, you would think that my neurologist and neurosurgen would care. Nope.
After switching doctors, my new neurologist has the same careless attitude towards how many percocet that I take daily. My he proscribes up to 6-500 mg per day. According to this recommendation I feel bitter about towards the highly uneducated pimps that call themselves doctors. So not only was my spine surgery not successful I know have to deal with liver damage.
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...
This is one case where it's counterintuitive.
Your liver makes acetaminophen into some really nasty toxic shit, and that's what damages it. Fortunately, it has another metabolic pathway that detoxes the stuff before it reaches toxic concentrations.
This pathway is powered by a limited stock of glutathione in the liver. When you run out, the toxic products start to accumulate rapidly and cause acute liver failure. Up until that point you are suffering no significant ill effects. Therefore you could take a therapeutic dose for extended periods with little ill effect, it only causes a problem when you overwhelm your capacity to produce glutathione.
Acetaminophen is the number one cause of acute liver failure in the USA and UK, but is not noted for causing chronic damage (or it would certainly not be available over the counter).
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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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,
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
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.
See here. It states in part that combining hydrocodone with other substances changes it from a Schedule II substance to a less restrictive Schedule III substance. The two example drugs they cite for this are Lortab and Vicodin - both containing acetaminophen.
Happy people make bad consumers.
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.
"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"
1. Vicodin is Hydrocodone
2. None of these painkillers require APAP to function, the anti-inflammatory effects of acetaminophen are auxiliary. The primary reason APAP is added to these drugs is to make them difficult to take in doses addicts can appreciate.
3. Acetaminophen is STILL effective at what it does and despite the misuse of it from ignorant users it is less harmful to the lining of the stomach than aspirin, does not increase the risk of people taking lithium or have sodium sensitivity like naproxen, and is not as definitely fatal in case of overdose as ibuprofin.
Acetaminophen is not perfect, but there's no perfect alternative and that is the very reason why we need to sustain as many options as possible for the diversity of medical needs people have.
"Most people, I think, don't even know what a rootkit is, so why should they care about it?"
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.
I've worked in a liver transplant unit, which is where Tylenol poisoned patients land... The whole idea is to make drugs like vicodin toxic in high doses and lethal IV. These are called "Compounded" drugs. They have a maximum dose, over which it becomes toxic. Drugs like oxycontin have no maximum dose (if you are adequately physically tolerant to opiate drugs) It's like similar to the practice of adding an adulterant (e.g. isopropanol, methyl ethyl ketone, methanol, etc ) to ethanol to make it undrinkable. In addition to Tylenol, atropine and aspirin are used as adulterants. The theory is that they will have less value to opiate addicts and it works. Compounded drugs are worth less on the street than uncompounded drugs. Almost Invariably, people who OD (not counting suicide attempts) on the Tylenol portion of a compounded drugs are abusing it. Furthermore, they are usually malnourished alcoholics who already have underlying liver disease... Last of all, most people aren't as susceptible to Tylenol toxicity as the people who get into trouble. I've seen quite a few addicts who were downing 40 pills a day of percocet or vicodin, with no ill effects.