FDA Considers Banning Acetaminophen-Based Pain Killers 631
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."
Vicodin? (Score:5, Funny)
As long as it doesn't cause Lupus...
Re: (Score:3, Funny)
It's not Lupus.
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Unless you didn't expect that I had seen that episode, in which case it would ironic.
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Yea, I've heard the damn vampire are tough to stomach in Santa Monica. The last thing they need is Werewolves too.
not really a ban (Score:5, Informative)
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)
Re:not really a ban (Score:4, Funny)
Thank God! --- R. Limbaugh
Re:not really a ban (Score:4, Informative)
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Hydrocodone is very mild compared to oxycodone. Oxycodone has something like 3000 (IIRC from medicinal chemistry well over a decade ago) times the affinity for the relevant receptor sites in the body as hydrocodone. Taking 30 oxycodone tablets is far from harmless... untreated, it would likely be fatal, as you'd stop breathing.
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Yes, let's protect people from their own stupidity. Next, we can make it illegal to sell desks without permanently attached foam on the corners to protect you in case you trip!
Anyone taking medicine should know they have to check for drug interactions and overdoses. The medical industry has been harping about it for years. If the product they offer is safe when following the directions, then it's not their problem if people do stupid things with it.
Re:not really a ban (Score:5, Informative)
Anyone taking medicine should know they have to check for drug interactions and overdoses. The medical industry has been harping about it for years. If the product they offer is safe when following the directions, then it's not their problem if people do stupid things with it.
What I think is funny is that the FDA is spending all this time over something that any half-way intelligent person should already know or at a minimal their doctor should have told them. What about all the drugs that they approve as safe that turn out to kill large numbers of people when they take the proper dose? eh? Maybe the makers of Tylenol are late on their hush money payment???
Avandia - Glaxo SmithKline, Banned 03-2000 for; heart failure, hepatitis, and liver failure
Baycol - Bayer AG, BANNED 08-2001 for fatal rhabdomyolysis
Bextra - Pfizer, BANNED 04-2005 for; heart attack, stroke, skin diseases
Dexatrim - Bayer, BANNED 11-2000 for fatal strokes
Ephedra - Brayton Purcell, BANNED 04-2004 for; high blood pressure, heart rate irregularities, insomnia, nervousness, tremors, seizures, heart attacks, strokes, brain hemorrhages, and death
Fen Phen - Wyeth, BANNED 09-1997 for; heart valve damage, primary pulmonary hypertension
Lotronex - Glaxo SmithKline, BANNED 11-2000 for; ischemic colitis, abdominal pain, severe constipation
Pondimin - Wyeth, BANNED 09-1997 for; heart valve damage, primary pulmonary hypertension
Propulsid - Janssen, BANNED 03-2000 for; torsades de pointes, SIDS
Redux - Wyeth, BANNED 09-1997 for; heart valve damage, primary pulmonary hypertension
Rezulin - Warner-Lambert, BANNED 03-2000 for severe liver toxicity
Vioxx - Merck, BANNED 09-2004 for; heart attack, stroke
This is only the short list... Thank you FDA for protecting us and the children!
Re:not really a ban (Score:5, Insightful)
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.
Re:not really a ban (Score:5, Insightful)
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?
Re:not really a ban (Score:5, Insightful)
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.
Re:not really a ban (Score:5, Interesting)
Red Flayer, you are amazing! 13 posts in 7 different threads in 6 hours... impressive. And nearly every one of them confrontational to boot.
COX 2 inhibition is one mechanism of anti-inflammatory action typical of the NSAIDs. When Vioxx was introduced, it was thought to be a better anti-inflammatory agent because it preferentially inhibited COX 2 over COX 1 (and COX 3, whose functions are not well understood as yet), and that this would reduce the incidence of gastric irritation associated with aspirin and some other NSAIDs. But it has been withdrawn from the market as its use significantly increases the risk of thrombus incidents: heart attacks and strokes. And it is now thought that this happens when the balance between COX 1 and COX 2 is shifted in a bad way. Which would suggest that aspirin, which nonselectively inhibits both, is possibly safer than any of the COX 2 inhibitors.
So, Red Flayer, your facts are correct... and they undermine your argument.
Besides, we were talking of the analgesic use of these drugs, and specifically in their role as a synergetic for oral opiates. This is a very different purpose with a very different kind of dosage regimen, and the COX inhibition mechanisms may not even be involved.
Oh, this also needs some further comment:
Re: the higher margin between therapeutic level and destructive overdose level, I'm not sure, and I can;t be bothered to look up the LD50 and therapeutic levels right now. What I DO know is that the margin between minimum therapeutic level and minimum toxicity level is much smaller for ASA than APAP. For a lot of people, side effects from ASA are experience at a *lower* blood concentration than the minimum therapeutic level.
The "minimum toxicity level" you are talking about here is the fully reversible tinnitus that I described as an early warning sign. Your spin doctoring seems inappropriate. Aspirin's way of usually causing "ringing in the ears" before any irreversible damage occurs remains an important positive feature of the drug. (I do realize that for someone posting so frequently over such a broad range of subjects, looking up certain critical details can be a bother, and I believe me I fully understand where you are coming from with that.)
Okay, I've been a good boy scout and fed the trolls. Hopefully in a way that some third parties reading this will find something of interest here.
Re:not really a ban (Score:5, Informative)
If you're lucky. Things have a tendency to go wrong with this course of medication, resulting in a fucked liver and a death spread over several weeks. It happened to my sister-in-law, and it's not pretty.
If you want to kill yourself, I'd suggest a nice clean OD on smack.
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What's so wrong with a good, 'ol firearm discharged to the temple?
Re:not really a ban (Score:5, Informative)
Re:not really a ban (Score:4, Interesting)
This is a good point, but in the U.S. at least, vicodin is still a prescription-only drug. It's not like you can just go to the store and buy a bunch of vicodin and extract the "good stuff" out and sell it on the street. If you can get enough vicodin to do that, then you already have a doctor who's willing to bend the rules to get you high, in which case he'd probably prescribe something that didn't have acetaminophen in it in the first place.
Re:not really a ban (Score:4, Insightful)
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.
Re:not really a ban (Score:5, Insightful)
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.
Re:not really a ban (Score:5, Interesting)
No, actually they will still inject, and they will have a higher chance of contracting Hepatitis or HIV.
Yes, but most anti-drug people are arguing from the basis of a puritan's punitive mythology, in which taking drugs is pleasurable and therefore drug takers "deserve" to be harmed. You can see this in puritans of all stripes: environmental puritans are often opposed to safe and effective means of disposal of nuclear waste because they would make nuclear power safer, which would be unacceptable because humans aren't supposed to have access to clean, cheap power, we're supposed to suffer for any pleasure we get, because we "deserve" to.
I have no idea what "deserve" means, other than, "I don't like what you're doing and want to see you get hurt as a consequence of doing it." It's a primitive, pre-scientific concept based on rudimentary rationalizations around social control behaviours in our primate ancestors, I think.
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Don't knock your rudimentary instincts, they got our species to where it is today. While there are plenty of people who think that our species is in a sad shape, myself being one of them, I'm still quite happy with my current state of evolution. I'd love to be more 'enlightened', but I'll take what I've got.
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To the conservatives, saying "don't do drugs, but if you do here's a free needle" would be the same as saying "drug use isn't encouraged, but isn't really bad either".
Why would it be that, and why only to conservatives? Surely if we live in an objectively real world, whether or not two things are the same as each other is independent of political bias!
My argument is not in the least intellectually dishonest: I am stating clearly and without equivocation what I believe to be true of the anti-drug side, bas
Re:not really a ban (Score:5, Insightful)
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?
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Re:not really a ban (Score:4, Interesting)
The acetaminophen is added because it increases the effectiveness of the narcotic, so a lower dose of the narcotic is needed for good pain control. Has nothing at all to do with controlling illicit drug use.
But what is fucked is that aspirin has this same effect with the narcotics and is much safer to use, and in fact aspirin + narcotic compounds used to be the common thing back in the day (prior to 1980). The change to acetaminophen compounds had to do with the profit margins of the pharmaceutical companies more than for any other reason. (Aspirin was the first ever drug synthesized in a laboratory and neither it nor any of the process that is used to make it can be patented. Plus the stuff is so easy and cheap to make that there is no way for a large pharmaceutical company to squeeze out smaller competitors. So aspirin is a failure in the American health care industry, despite its therapeutic effectiveness. No profit there.
Citation Needed (Score:3, Insightful)
I think I'll need a citation for this one. I find the logic suspect that a typical recreational drug user would avoid abusing Oxys out of concern for acetaminophen overdose.
The article claims that acetaminophen and oxycodone, et al, are packaged together because they act on different pain receptors. I find this explanation to be far more believable than yours, sorry.
Citation Provided (Score:5, Informative)
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I'd say its highly irresponsible to claim that 24 pills of 5mg Oxycodone will not kill an Opiate-naive individual.
Re:not really a ban (Score:5, Interesting)
Drinking alcohol with it also will destroy your liver faster than either alone will. An over the counter cough medicine with both acetaminophen and alcohol in it is especially dangerous.
Tylenol has never worked for me, even Tylenol with codeine (percocet?). If I'm prescribed Tylenol with codeine, I have to take an aspirin with it to make it work. Perhaps they'll bring back Darvon (aspirin and codeine).
I don't see (aside from advertising and bribing doctors and hospitals) why acetomenaphine needs to be on the market at all, as there are a plethora of newer, more effective, and safer analgesics these days. Acetominaphine won't relieve swelling at all, while aspirin and other analgesics will.
Of course no drug is completely safe -- my friend Charlie had to be operated on for a perforated intestine that her doctor said was caused by taking too much naproxin. But that's far preferable to a liver transplant.
Re:not really a ban (Score:5, Informative)
Bottom line: READ THE DAMN LABEL. Make sure you're not taking too much. Check with your doctor if you're not sure. A lot of medications will screw you up if you take too much. Equip yourself with knowledge and you'll be fine.
Re:not really a ban (Score:5, Informative)
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Acetaminophen has a lot of uses, actually. In recommended doses, it's perfectly safe and doesn't cause any liver damage. It's only when you combine it with other things or OD that it becomes problematic.
Unlike aspirin, acetaminophen is safe for children as it doesn't cause Rhye's syndrome. It's safe for pregnant women. It doesn't irritate stomach lining and so is safe for those with gastric ulcers.
It's method of operation is unlike other drugs (especially opiates) and the combination leads to less amount of
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I have a very effective hangover cure, part of which is centuries old. Rye ("hair of the dog") is not a good solution.
First, smoke a joint. That will cure the nausea and make your stomach ok for the rest of the cure.
Second, drink a bunch of water (or better yet, gatoraide). Without the pot you're going to throw up any water you drink, while the reefer will make you thirsty. Part of the hangover is from dehydration.
Third, make some home made eggnog (why it's traditionall a holiday drink). Unfortunately, stor
Re:not really a ban (Score:4, Interesting)
It's the combination that causes problems; people wind up overdosing
I always figured this was intentional, to poison the people who are abusing them. If anything the individual formulations are more likely to be abused, and doctors will be less likely to prescribe them. It's really unfortunate the medical field often considers punishing addicts to be a higher priority than helping those in pain.
In any case, multi-drug formulations are dumb. Even the over the counter cough syrup formulations. The one you most commonly see is dextromethorphan and guaifenesin . The dextromethorphan is intended to suppress coughs, but you shouldn't take it with a "productive cough", that is, one that produces phlegm. Obviously if you're coughing up phlegm you want to get it out of your lungs, so suppressing that cough is a bad idea.
Ok, but then they through guaifenesin into the mix, which is expectorant. An expectorant is a drug that breaks up mucus so it's easier to expel by coughing. In other words, it's designed to make your productive cough more productive. WTF are they doing pairing it with a substance that shouldn't be used with a productive cough?
It's just stupid. I never buy medications with more than one active ingredient, and mix and match as needed. Obviously this is always going to be better than some one size fits all solution simply created so the marketers would have more product lines to market.
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With the combination, I would - at least sometimes - end up just coughin
Re:not really a ban (Score:4, Informative)
The guaifenesin isn't really in there as an expectorant. It's in there because if you chug the whole bottle, the guaifenesin will make you throw up, discouraging you from using the dextromethorphan to get high.
I'd rather take it with with theobromine [wikipedia.org] than dextromethorphan.
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Tylenol is nasty dangerous stuff. It's very easy to misuse it to a lethal degree.
Warning labels generally are not sufficiently dire assuming they are even detailed enough.
On the one hand, I am not really surprised. On the other hand, I wonder why they
took so bloody long. Tylenol by itself is dangerous enough, you don't really have
to mix it. So given how long it took for the Feds to take action, it doesn't
really seem to be that serious.
Successful diet pills get more diligence than the Feds are showing here.'
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Tylenol is nasty dangerous stuff. It's very easy to misuse it to a lethal degree.
Really? How so? By not reading the damn labels? I mean seriously, anything is easy to misuse at that point. How hard is it to read a label of Tylenol that says "Adults: No more than 2 tablets every 4-6 hours with no more than 8 tablets in a 24 hour period" And if you do the math, guess what? 2 tablets every 4-6 hours is 8 tablets in a 24 hour period (assuming you wait the full 6 hours).
Tylenol is no deadlier than any other drug on the market. Too damn many people just don't read their labels. If you
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Tylenol is no deadlier than any other drug on the market.
From memory from a course I did at university, Tylenol (or Paracetamol, as we call it here) has a very low therapeutic index (ratio of lethal to effective dose), which is unusual for a drug which is commonly used by many people. It happens to be quite a big cause of liver damage worldwide. This wikipedia page [wikipedia.org] seems to agree with that, suggesting a toxic/effective ratio of about 10.
Unfortunately, I can't find other web references for this, can anyone else help out by linking to a list of LD50/ED50 ratios for
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Regardless that it would be more effective and less dangerous than most NSAIDs
No. It's not. That's the point.
Aspirin is safer than acetaminophen. Ibuprofen is safer than acetaminophen. For that matter, narcotics are safer than acetaminophen -- you are, no shit, better off with a lifelong narc dependency than you are poisoning yourself with this crap. And it's been pushed on us for years, in various ways, by a well-funded lobby which has all the compassion of the Mafia and all the ethics of your typical
If You Drink Alcohol Avoid Acetaminophen (Score:5, Informative)
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.
Re:If You Drink Alcohol Avoid Acetaminophen (Score:4, Informative)
This is true. Any pharmacist will tell you to take Motrin or Advil (Ibuprofen) instead, as it skips the liver and is not nearly as toxic
Re:If You Drink Alcohol Avoid Acetaminophen (Score:5, Insightful)
Maybe your sister should have told you not to drink that much alcohol in first place. Makes a lot of more sense that way.
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Not that I recommend anyone do this, but there's evidence [aspetjournals.org] that replacing the reducing equivalents available to your liver with a supplement like SAMe can reduce hepatoxicity of acetaminophen(APAP).
Re:If You Drink Alcohol Avoid Acetaminophen (Score:5, Informative)
Oh, I should have mentioned this. Aspirin and ibuprofen can damage the stomach lining, and drinking alcohol thins the blood which can increase the risk of stomach bleeding. Best thing to do for a hangover is to drink water and coffee and smoke some pot. If you absolutely must take an analgesic, use ibuprofen it doesn't thin the blood as much as aspirin does.
Re:If You Drink Alcohol Avoid Acetaminophen (Score:5, Informative)
Alcohol damages the liver as it's broken down and so does acetaminophen
Not necessarily. Normal metabolism of either alcohol or acetaminophen isn't damaging, but it uses up reducing equivalents (such as those sulfhydryls on methionine and cystine). It's only when those reducing equivalents are used up that acetaminophen is shunted into another metabolic pathway that it produces toxic metabolites. In moderation drinking alcohol xor taking acetaminophen is safe.
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It's actually the 2nd step in alcohol metabolism, the aldehyde dehydrogenase that uses up reducing equivalents. Here's a nice summary [ceri.com] of what happens.
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By the logic in this thread I would suggest that is is alcohol we should take off the market. After all, it damages your liver and all kinds of alcohol can be purchased WITHOUT the advice and guidance of a professional. Furthermore, it is understood that you need to take care when taking medicine; otherwise why would you need a prescription to take much of it. However, it is not the same for alcohol.
I wouldn't go that far, and I find a small problem with your reasoning. While it's true that the warnings against taking too much acetaminophen are printed clearly on the drug facts label while the alcohol containers have only the vague "may cause health problems" warning, the effects of taking too much alcohol can be readily seen. One becomes aware of intoxication, people feel physically sick, and, ultimately, the person is fully aware that they're hurting themselves. All of this can occur in a single nigh
Doctors orders (Score:4, Informative)
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.
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If people want to destroy their liver after being warned, then so be it. I think it is overreacting for the FDA to ban something that has been used successfully for decades when no new side-effects have been discovered. We knew for a long time that acetaminophen is dangerous in large doses, so are a lot of things.
Why? (Score:5, Insightful)
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.
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Would it not make more sense to educate the people taking the pills, instead of banning an effective pain reliever?
No, because there are too many over the counter medications with acetamenophine in them. If you're takinig vicodin for your injury and cough syrup for your cough and then a shot of Nyquil before bed, you may not know that the cough syrup and Nyquil have tylenol in them.
Better to take the tylenol out of the Vicodin and Nyquil and cough syrup. If theat were the case and you overdosed, then it wou
Only because of stupid people. (Score:4, Insightful)
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!
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I think the point is that it is easy to misuse even if you are careful. That's becasue it's in so many products.
However, not letting a doctor prescribe it is just stupid.
Re:Only because of stupid people. (Score:5, Interesting)
Not really look at a tylenol bottle. Yeah it says no more then 6 or 12 in a day but it's incredibly tiny and hard to read. And nowhere does it talk about using it with other drugs of that type other then a generic consult your doctor blah blah blah. And who talks about tylenol with your doctor? I means it's been on the market a while and is 100% safe right? I agree there is a lot of stupid shit out there but I feel this case isn't one of them.
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"So we ban something because the average person is too stupid to read the bottle?"
Perhaps if ti's the average person, then there is an issue.
Anyways, this is just a ban from putting two specific medication together in the same pill. There reason are good and are not "because the average person is stupid".
Of course, one if the most stupidest things someone can do is post about an article they clearly didn't read. Of course, the most stupiest thing, bar none, is having a land war in Asia.
So wait... (Score:4, Insightful)
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*?
Re:So wait... (Score:5, Informative)
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)...
This is not true at all. Acetaminophen and narcotics are mixed because the combination is a much more effective pain reliever than either alone.
Well (Score:3, Insightful)
If this is an issue with miss use, then pulling it from the shelf seems ok; however not letting a doctor prescribe it is just stupid.
This is not a ban (Score:3, Informative)
What is being proposed is not a wholesale ban on acetaminophen but a ban on *some* drug combinations that include it and a reduction in the maximum OTC dosage. The drug will still be available and you'll still be able to mix drugs yourself to get the old effect.
Re: (Score:3, Interesting)
What is being proposed is not a wholesale ban on acetaminophen but a ban on *some* drug combinations that include it and a reduction in the maximum OTC dosage. The drug will still be available and you'll still be able to mix drugs yourself to get the old effect.
THERE are A LOT of people suffering with extreme pain because they can not get the proper pain medications because the DEA goes after doctors who prescript 'too much of X Y or Z'. If you think it's going to be EASIER to get pure oxytocin after this ban you are out of your mind.
We really need to grow up and get over the whole 'but someone is going to abuse or misuse it" bullshit. LET THEM! when they steal a TV to support their habit then throw their asses in jail. O but wait... if the drugs where available t
As someone with a lortab prescription... (Score:5, Interesting)
... 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.
Well then don't do that (Score:2)
Also, if you take any of these pills and then drive your car into a telephone pole or across the median of a highway you could die. Also, if you don't take any of these pills and then drive your car into a telephone pole or across the median of a highway you could die. I think this is a classic case of "don't do that, stupid"
Logic fail (Score:2, Insightful)
Hydrocodone has 0 requirements to be "cut" with acetaminophen. Neither does oxycodone. It's just done as a way of limiting a patient's intake of the various painkillers that are mixed with acetaminophen. Look at the dosing for Vicodin for instance (I had neck surgery a while ago for a herniated neck disc & did a bit of research);
- 5mg hydrocodone for 500mg acetaminophen
- 7.5 for 750
etc
Similar ratios with oxycodone.
So you really end up being limited by the amount of (unecessary) acetaminophen which has _
Just in time (Score:2)
For some fresh drama on an aging "House, MD"
Alcohol (Score:5, Insightful)
So when will the FDA ban alcohol for destroying people's livers?
Re: (Score:3, Insightful)
The US government tried banning alcohol. It didn't take.
Re: (Score:3, Informative)
Taking double the daily recommended maximum dose of alcohol will not destroy your liver.
Taking triple the daily recommended maximum dose will not destroy your liver.
Alcohol will cause acute CNS depression and kill you long before it causes acute liver damage. Only chronic abuse allows it to scar your liver. The same is not true of acetaminophen.
Why BAN and not WARN? (Score:5, Insightful)
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).
michael jackson,heath ledger,anna nicole smith... (Score:3, Insightful)
the issue is not education, as everyone getting a medical degree in anesthetics is impractical, nor is it competency and monitoring, as these celebrities are people who certainly could afford that, and still wound up dead. the issue is the fact you are dealing with addictive substances and intolerant thresholds to real damage and death
banning is superior to warning, as simple human nature is incompatible with responsible use of these substances. warning simply doesn't work
Thanks, but it's too late for me. (Score:3, Informative)
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.
Therapeutic Index (Score:4, Insightful)
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...
how about Glypizide? (Score:4, Insightful)
Jaundiced junkies in the ER, (Score:5, Insightful)
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.
Not Banning Acetaminophen-Based Pain Killers (Score:3, Informative)
Include the antidote ! (Score:3, Interesting)
I also remember watching "Tomorrows World" as a kid, and one program had mentioned and "invention" of putting the Acetaminophen andtidote in the tablets so you couldn't overdoes or have liver damage. I'm assuming it was N-acetylcysteine (NAC) , but it could have been somethign else. This was TWENTY YEARS AGO. But for some reason lost to me and probably a lot of people it never happened.....
The problem is Acetaminophen (Score:4, Insightful)
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.
OMG kill it! (Score:4, Informative)
"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.
How about doctor administered only (Score:3, Interesting)
How about doctor administered only, instead of just COMPLETELY illegal.
If i take about 5000mg of caffeine all at once, wont that damage my liver too, then maybe we should illegalise caffeine too?
If people are stupid with drugs, then that is their fault, in Europe, you have weed which is legal, why are we still in this neo-nazi community where they have to wait to the last possible moment before legalizing something (ie - alcohol) before they realize once legal, then people will be more responsible with dosage, as they will have to become more informed!
Oh for crying out loud. (Score:3, Insightful)
Doesn't anyone RTFA? Not even the submitter?
They are talking about removing the acetaminophen from the prescription meds. They are not talking about removing it from the market entirely.
This is to prevent inadvertent overdosing. Take a vicodin and a tylenol and you are double dosing on the acetaminophen. Most people don't know this.
IMHO this makes huge sense. Any time you combine prescription and over-the-counter meds in the same pill, you risk ODing on the o.t.c.
Umm, that's the POINT.. to be toxic. (Score:4, Informative)
only banned (Score:3, Funny)
Re:What will kill pain then? (Score:4, Informative)
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.
Re: (Score:3, Insightful)
Re:more pointless prohibition (Score:4, Insightful)
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.
No it's not, read the FUCKING ARTICLE (Score:2)
They are considering banning them from being put in the same pill as other drugs. You will still be able to take them as separate pills.
This is actually seems to be a good thing.
"...prohibition is totally what people want from their government."
Some people do. I mean not what THEY enjoy, just what others seems to. F'n neo-cons.
Easy to OD on acetaminophen. Need better labels. (Score:5, Insightful)
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,
Re:House, MD (Score:5, Funny)
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.
Re:House, MD (Score:5, Insightful)
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.
Re: (Score:3, Insightful)
The problem is that obviously, a large segment of people are ODing on acetaminophen and their getting liver damage. This being America where nothing is anybody's fault, obviously the fault lies with the product.
I'm all for education. Hell make the label really explicit to say something like "DO NOT EXCEED 2000MG PER DAY OR YOUR LIVER WILL EXPLODE!!!!"
If the FDA does ban acetaminophen based pain killers, a HUGE (bigger than it already is) black market is going t
Re:I for one (Score:5, Informative)
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.
Re: (Score:3, Insightful)
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.
Re: (Score:3, Informative)
Re: (Score:3, Interesting)
Are you sure they failed? Alcohol laws continue to get stricter and stricter. The prohibitionists realized that you can't take it all away overnight, instead you have to slowly take it away.
Re:But for what durration? (Score:5, Informative)
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).