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."

Comments

Vicodin?

[Megaweapon]

As long as it doesn't cause Lupus...

Re:Vicodin?

[clem]

It's not Lupus.

Re:Vicodin?

[the-matt-mobile]

Sarcoidosis?

Re:Vicodin?

[JAZ]

Coincidentally, I recently watched episode of Futurama, "The Devils Hands are Idle Play Things", which does a nice job of distinguishing the difference between coincidence and irony.

Unless you didn't expect that I had seen that episode, in which case it would ironic.

Re:Vicodin?

[IcyNeko]

Poor House. I heard they're banning Acetaminophen and Narcotic mixed pain killers... including Vicodin. WHY IS THE MAN AGAINST DOCTOR GREGORY HOUSE???

Re:Vicodin?

[Smooth and Shiny]

Yeah... it's never Lupus.

not really a ban

[mr100percent]

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

[Anonymous Coward]

Before everyone screams bloody murder, the fact remains that you'll still be able to buy the stuff, separately

Thank God! --- R. Limbaugh

Re:not really a ban

[ckthorp]

Except the article clearly states that Vicodin is actual hydrocodone+acetaminophen...

Re:not really a ban

[brainboyz]

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

[BrokenHalo]

Thirty extra-strength tylenols at once can destroy your liver and you'll die within 72 hours.

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.

Re:not really a ban

[Bitch-Face Jones]

I'm not so sure about that. One of the reasons that drug companies put acetaminophen in things like hydrocodone and dextropropoxyphene in the first place is because they make it more difficult (ironically) to overdose on or use recreationally. If you try and just down 12 vicodin at once, all of the acetaminophen in it is going to make you pretty sick, so you have to jump through quite a few hoops (like using a cold water extraction) if you want to get the good stuff out without having to deal with the acetaminophen.

Re:not really a ban

[mcgrew]

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

[jedidiah]

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.'

Who stands to gain here and who is greasing the relevant palms.

Re:not really a ban

[PCM2]

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

[Hatta]

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.

Re:not really a ban

[ae1294]

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

[Craig Davison]

One of the reasons that drug companies put acetaminophen in things like hydrocodone and dextropropoxyphene in the first place is because they make it more difficult (ironically) to overdose on or use recreationally.

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

[fuzzyfuzzyfungus]

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?

Re:not really a ban

[DurendalMac]

Acetomenaphine is the only OTC painkiller that is safe for pregnant women to take AFAIK. Aspirin is a big no-no and Ibuprofen is iffy at best. It's always good to have options. You can burn a hole in your stomach with too much Ibuprofen. Should that be pulled from the market too?

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

[Anonymous Coward]

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

[fuzzyfuzzyfungus]

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?

Re:not really a ban

[anotheregomaniac]

There is a synergistic effect between the two drugs that enhances the pain relief from the narcotic and reduces the amount of narcotic needed to achieve relief. Separating them will require doctors to prescribe the two be taken together or more of the narcotic.

http://en.wikipedia.org/wiki/Vicodin#Pharmacokinetics

I recently had surgery and was given clear instructions about avoiding anything with acetaminophen while taking Vicodin. If adding a little acetaminophen reduces the amount of narcotic needed, I think that is a good idea, as long as instructions are followed.

I would think all the OTC remedies that mix acetaminophen in with every known variety of other drug would be a much greater problem w.r.t. acetaminophen overdose.

Re:not really a ban

[businessnerd]

I really have to second this idea, but not just painkillers. Every medication has a label with extremely specific guidelines on how to take it (or not take it). Those labels go through painstaking copy review to make sure that the user has the tools to take the medication safely. But almost nobody reads them. For example, one day my wife missed two days of her birth control and didn't know what to do, so she was just going to come up with something on her own. I told her she should read the label and see what it says. She's been taking birth control for years and has never bother to read it. I read it and it said exactly what to do in every type of situation of missed pills at various points in the cycle and each situation had different instructions. It's a good thing I read it because she was planning on doing what was NOT recommended. While she wasn't in danger of overdose or anything like that, this type of drug messes around with your cycles which can cause a whole mess of uncomfortable issues or pregnancy (totally not ready for that). Everyone has been in a situation where they weren't sure what to do with their meds so they just guessed, but if they read the damn label it would tell them exactly what to do. Every time you get a new medication, sit down and read the label. It can be a surprisingly interesting read.

Re:not really a ban

[Slashdot Parent]

What's so wrong with a good, 'ol firearm discharged to the temple?

Re:not really a ban

[gamanimatron]

I actually really like the dextromethorphan/guaifenesin combo. I used to get really nasty colds a few times each year, (they stopped about the same time I stopped smoking - suspicious, that) and found that neither alone was as effective. Guaifenesin alone would help clear out the gunk, but I'd be miserable with recurring bouts of dry hacking, and dextromethorphan alone would stop the wild coughing but leave me with half-full lungs.

With the combination, I would - at least sometimes - end up just coughing enough to clear things out.

Re:not really a ban

[Red Flayer]

I think perhaps the parent to your post is currently under the influence of one or more of those narcotics. Or he just made an regular casual mistake, but I prefer to be cynical.

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. Of course, it's illegal to take oxycodone in any manner other than as directed by a physician, so we don't have to worry about that, right? Right?

Anyway, here's the deal:

Ask your doctor before you take any medication in conjuction with a prescription medication. At the very minimum, ask your pharmacist (the pharmacist will have better knowledge of potential drug interactions, but poorer knowledge of your personal medical situation). I'd do both.

Re:not really a ban

[Daniel Dvorkin]

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 sewer rat.

Re:not really a ban

[theydidnthavemyname]

This is not why acetaminophen (aka paracetamol in UK & other places) is combined with opiates in compound preparations. Acetaminophen is an effective painkiller and it works in a different way to opiate drugs meaning that you take a smaller dose of opiates to get the same effect on your pain. Opiates have more side-effects (e.g. constipation, nausea) and also the problems of addiction and tolerance. NSAID drugs like ibuprofen can also be combined with acetaminophen meaning you take a smaller dose of them (they can cause damage to the stomach lining and kidney amongst other things). Paracetamol (sorry so much easier for me to type) is very well tolerated, side-effects are much rarer than other analgesics - its only major downside is that its so damned unpleasant in overdose. Paracetamol is really commonly taken in attempted suicide and also overdose as a 'cry for help' in the UK. Its really heart-breaking how many patients i see who take an overdose, wake up and regret it only to have their liver slowly fail over the next few days and sometimes die a horrific death. Unintentional overdose with paracetamol is much, much rarer. Despite this, i will always prescribe paracetamol to people who are in MASSIVE amounts of pain (cancer, post-op, palliative, trauma) as a first line in combination with other painkillers. Yes on its own it will only help with mild pain but thats not the point. Some people here seem to think that their doctor is precribing them something ineffective or trying to con them. That just isnt true.

Re:not really a ban

[radtea]

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.

Re:not really a ban

[Zerth]

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 than dextromethorphan.

Re:not really a ban

[Otto]

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 both needed to produce the desired effects, which is why they combine it with those drugs. Hell, the stuff even works effectively in combination with aspirin (aka Excedrin), leading to a greater effect with less total dosage of either individually.

The fact is that acetaminophen is practically a miracle drug. It works incredibly well with virtually no side effects. Unfortunately, the effective dose happens to be rather high when compared to the damaging dose (1/16th) which is unlike most other drugs (most other drugs fall into the 1/30th to 1/50th range).

Anyway, I'm against the law banning any particular drug in general, because there may be an effective use of that drug in specific cases. My medicine should be between me and my doctor, not subject to government dictates.

Re:not really a ban

[b96miata]

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.

Re:not really a ban

[L0rdJedi]

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've already taken a painkiller, it's probably safe to not take any more tylenol. If you have a question, call your freaking doctor. Again, too damn many people try to be their own doctors that it's no wonder people get hurt. You can in fact take Ibuprofen and Tylenol in combination if you take them 3 hours apart (Ibuprofen, 3 hours later Tylenol, 3 hours later Ibuprofen, wash, rinse, repeat).

And every bottle of anything I've ever seen that has acetameniphen in it says "Do not take in combination with alcohol". Just because other people are stupid and don't read the label on their meds doesn't mean I should be penalized. Changing the label on children's tylenol had no effect on those of us with a clue, but an outright ban is going to hurt, especially when the kids are miserable with pain and low grade fevers.

Re:not really a ban

[sammaverick]

I don't even RTFA and you want me to RTFL? Inconceivable!

Re:not really a ban

[mcgrew]

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, store bought eggnog will not work, as it's been pasteurized. Egg yolks contain an emzyme that is very effective against hangovers, but heat destroys the emzyme. And since one in three store-bought eggs in the US has samonella, you'd better know someone raising their own poultry to get the eggs from or you're liable to ba a lot sicker than just a hangover.

If you do wind up getting samonella from it, eat cottage cheese after you get over the runs. Diaharria flushes out the intestines' flora, and cottage cheese replaces these organisms.

But there's an even better hangover cure that takes only one step. Unfortunately, you need an acetylene torch for that. Just turn on the green hose and inhale deeply. Pure oxygen will cure your hangover in less than a minute, but it has two dangers. First, too much pure o2 can cause brain damage, and second, if you're hung over and turn on the red hose by mistake you're going to be puking your guts out all morning. Yes, I know this from experience...

Re:not really a ban

[Will.Woodhull]

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

[Will.Woodhull]

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.

Re:not really a ban

[mr100percent]

Yes, any half-way intelligent person SHOULD know not to take tylenol, but there's many thousands of accidental overdoses every year in emergency rooms all over the country. Some of these people get all upset and blame the government for making it OTC and not warning them if eating the whole bottle can kill you. Yes, their logic is pretty bad, but the public can be stupid.

Your list is inaccurate, the FDA did warn about many of these drugs, but they were not banned. Avandia is still on sale today, as well as in formulations like AvandiaMet. Vioxx was voluntarily pulled from the market by Merck and not the FDA, which probably would have been fine with it as long as it had some sort of black box warning on it.

Re:not really a ban

[BitZtream]

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.

Re:not really a ban

[Will.Woodhull]

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

[radtea]

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, based on my experience with them and other puritans over many years. I believe that their explicit arguments are incoherent, like the one you've presented here, and therefore infer that there is another reason they are against these things, and that they are either two cowardly to say it out loud or too unreflective to be aware of (it in fairness, I think the latter is depressingly common.)

The claim "making a dangerous activity less dangerous encourages it" fails the test of empiricism on many counts--so many that it is very, very difficult to credit anyone who makes that claim with any intellectual honesty whatsoever.

It is well-known and well-documented that the United States, one of the least free jurisdictions in the developed world, has a much higher rate of drug use than other, more-free jurisdictions: http://www.sciencedaily.com/releases/2008/06/080630201007.htm

This despite the conservatives doing everything they can to make drug use as dangerous as possible to users, including limiting access to needle exchanges and treatment, violent interdiction of drug supplies, and incarceration of everyone involved in the drug trade from high level dealers down to individual users.

So it is not clear why conservatives would think that liberal drug laws and programs like needle exchange and other public health measures, which have a record of getting addicts into treatment in other, more free, jurisdictions than the United States, constitute "condoning" drug use. It seems to me on the contrary that such programs do nothing but recognize the fact that drug use is bad... so bad that considerable public health resources need to be directed at the problem of treating addicts, to make things better.

It is ONLY if you take a purely punitive attitude toward drug use on the basis that it is "pure evil", in the sense that "whatever the consequences, it is still bad," that such an approach makes sense, at least to me. I really and honestly don't see any other way to read conservative policies, given the objective facts of the matter: freedom-oriented, health-oriented policies reduce drug use.

Conservative, punitive policies increase drug use by making it harder for addicts to get help and destroying the legal employment prospects of people found guilty of drug crimes. Conservative policies, at the same time, make drug use more dangerous.

Can you give me any non-punitive, non-desert-based account of why conservatives think this is the right thing to do? And failing that, can you give me any rational justification for the claim that drug users "deserve" to be harmed by their activity? I just don't see it.

Re:not really a ban

[gringer]

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 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 drugs (in particular, Tylenol)?

FWIW, here's one, which has the following ratios:
psilocybin (psychadelic mushrooms): 641
vitamin A: 9637
LSD: 4816
aspirin: 199
nicotine: 21

If You Drink Alcohol Avoid Acetaminophen

[eldavojohn]

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

[mr100percent]

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

[dunkelfalke]

Maybe your sister should have told you not to drink that much alcohol in first place. Makes a lot of more sense that way.

Re:If You Drink Alcohol Avoid Acetaminophen

[Hatta]

Not that I recommend anyone do this, but there's evidence 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

[Hatta]

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.

Re:If You Drink Alcohol Avoid Acetaminophen

[Hatta]

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

[snl2587]

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 night during which little liver damage takes place, and the person can use their sickness as a warning against further abuse or ignore it; it's their choice.

Taking too much Tylenol, on the other hand, does not manifest itself right away. As long as the headache goes away a lot of people will say "screw the warning, I want to feel better so I'll take six...it's never hurt me before". And so without recognizing the problem and despite being warned, people take too much and can't feel their consequences until it's too late.

Personally I'm not in favor of banning either drug, and I really wish the government would just keep providing the warnings as they always have and leave it to the people to ignore them.

Re:If You Drink Alcohol Avoid Acetaminophen

[Hatta]

It's actually the 2nd step in alcohol metabolism, the aldehyde dehydrogenase that uses up reducing equivalents. Here's a nice summary of what happens.

Doctors orders

[DerekLyons]

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.

Why?

[muridae]

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.

Re:Why?

[mcgrew]

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 would be your own fault.

Darvocets are far less effective than the older Darvons for injuries, because acetameniphine won't reduce swelling while aspirin will. Of course, aspirin is so cheap and easy to make that it isn't the cash cow for the pharm companies, which is why they push the less effective, more dangerous Tylenol.

Re:What will kill pain then?

[Freetardo Jones]

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.

Only because of stupid people.

[Lumpy]

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!

Re:Only because of stupid people.

[jlechem]

'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.'

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.

Re:Only because of stupid people.

[geekoid]

"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...

[moosehooey]

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...

[phizix]

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

[geekoid]

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.

Re:more pointless prohibition

[njfuzzy]

It's easier to live without one arm than without one liver. Food for thought.

This is not a ban

[wiredlogic]

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:This is not a ban

[ae1294]

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 to those who wanted them and they didn't have to pay $50 dollars a pill they might not need to steal you say? THAT'S a THOUGHT CRIME SIR and you are NOW on OUR LIST.

Want a citation? I'll be your fucking citation as its happened to me and it's not very much fun.

As someone with a lortab prescription...

[ScytheBlade1]

... 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.

Re:As someone with a lortab prescription...

[phizix]

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.

Generally, it is the narcotic causing the nausea, not the acetaminophen.

Re:House, MD

[ae1294]

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.

Logic fail

[forgottenusername]

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 _nothing_ to do with the RX painkillers in question. The fact that liver damage etc is so prevalent with acetaminophen simply means they need to remove that component of it, and people consume that as as seperate pill.

Such silliness. Don't force people to take acetaminophen if they don't need it - damage from that is a very real problem with these painkillers. It makes no sense - "let's prevent people from overdosing on the painkiller by adding in something that will cause liver failure if they take too much of it!" "omgz grate idea I just happen to have a great deal worked out with this acetaminophen provider. We'll all get rich!"

Re:I for one

[Freetardo Jones]

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.

Alcohol

[sexconker]

So when will the FDA ban alcohol for destroying people's livers?

Re:Alcohol

[MightyYar]

The US government tried banning alcohol. It didn't take.

Re:Alcohol

[Empty Threats]

Taking the daily recommended maximum dose of alcohol will not destroy your liver.
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?

[Fallen Kell]

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).

Re:more pointless prohibition

[Austerity Empowers]

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.

Thanks, but it's too late for me.

[Anonymous Coward]

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

[Dr_Barnowl]

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...

Re:So too much acetaminophen can kill you?

[EastCoastSurfer]

Well, the same can be said for alcohol, let's ban that. Wait, we tried? And failed? Damn.

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.

Where is this 2,000 mg number coming from?

[Anonymous Coward]

As a nurse, I know that the current FDA limit is no more than 6,000 mg per day for up to ten days. Where is this new number from?

cigarettes

[CyBrett]

Yet we still allow cigarettes to be legal even though we know for sure that they cause lung cancer.

Re:But for what durration?

[Dr_Barnowl]

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).

how about Glypizide?

[techno-vampire]

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.

Easy to OD on acetaminophen. Need better labels.

[Ritz_Just_Ritz]

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,

Summary is factually wrong; daily limit is 4000mg

[Sangui5]

2000mg is not the daily limit for acetaminophen; 4000mg is. 2000-3000 is the limit for "at risk" populations (e.g. existing liver disease). The linked article doesn't even mention a dosage limit. You can take your 2 Percocets and 2 extra strength Tylenol and still be under the dose limit; that's only 2300 mg even with the high-dose Percocets.

It's one thing to be concerned about an overdose and set a dose limit; it's a completely different thing to arbitrarily lop the max dose in half to cause hysteria.

Jaundiced junkies in the ER,

[pigwiggle]

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.

You can't regulate stupidity and ignorance

[Rastl]

When you get your prescription for these drugs filled the pharmacist tells you not to take Tylenol with it. Your doctor should be asking if you're taking Tylenol. They're doing their jobs.

The specific combination of drugs is also important. My husband requires brand name Vicodin (at a premium cost) because there's something about the way they make it that just works much better than generics for him. Getting hydrocodone and taking it with Tylenol isn't going to do that.

If people can't read the labels and aren't following instructions then they're going to find another way to fuck themselves up. If you sell the narcotic separately do you really think for one moment that they're not going to abuse that? "Take one of these with 2 Tylenol every 4 to 6 hours" = "Take a whole bunch of the good ones and screw the Tylenol" in those people's minds.

I don't see taking a highly useful class of drugs off the shelf because people are stupid. Who do I write to stop this idiocy?

Citation Needed

[Slashdot Parent]

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.

Re:What will kill pain then?

[xyphor]

You can get a script for just hydrocodone or oxycodone, but doctors don't like to prescribe them because of DEA pressure. Oxycontin is oxycodone plus acetaminophen (like percocet) but is time released.

Not Banning Acetaminophen-Based Pain Killers

[Fieryphoenix]

They are not. They are considering banning combination drugs that include acetaminophen, because there have been fatal overdoses when people additionally took acetaminophen.

I think there's a bigger problem

[m1ss1ontomars2k4]

I think there's a bigger problem if you've already taken your PRESCRIPTION pain-killers and then you still take Tylenol. At any rate, I prefer acetaminophen because it fixes my headaches and doesn't need to be taken with food like ibuprofen.

Include the antidote !

[Brit_in_the_USA]

In the UK you can only buy ~Qty. 10 (I forge the exact number) Acetaminophen at a time at supermarkets, the checkout computer blocks or requires overrides.

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.....

Allergic to acetaminophen

[wift]

This is good for me as I'm allergic to acetaminophen. It could kill me so I'd have to make sure I didn't get any. My dentist who was made aware of my allergy unwittingly prescribed Hydrocodone to me, my pharmacy missed it and luckily my wife knew Hydrocodone contained acetaminophen otherwise I wouldn't be typing this.

Re:I for one

[xyphor]

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.

michael jackson,heath ledger,anna nicole smith...

[circletimessquare]

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

Citation Provided

[Tyler Durden]

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.

The problem is Acetaminophen

[Budenny]

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.

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[account_deleted]

Comment removed based on user account deletion

OMG kill it!

[Aphoxema]

"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

[hesaigo999ca]

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!

Re:House, MD

[plague3106]

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.

Oh for crying out loud.

[Hillgiant]

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.

Re:I for one

[fafalone]

I normally wouldn't correct something like this, but this is /. so minor technicalities cannot go uncorrected. The DEA, not the FDA, determines which CSA schedule a drug is placed in.

Re:House, MD

[Mysticalfruit]

Ding, ding, ding... you get the brass ring...

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 to spring up, which is only going to get more people maimed/killed/livers exploded

* I make this claim on the idea that some people will actually sell real acetaminophen based pain killers, the rest will just sell counterfeit crap.

Umm, that's the POINT.. to be toxic.

[dickmerkin]

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.

only banned

[bugs2squash]

in teenager's underwear