FDA Considers Banning Acetaminophen-Based Pain Killers 631
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by
ScuttleMonkey
from the welcome-to-the-nanny-state dept.
from the welcome-to-the-nanny-state dept.
Greg George writes "The FDA has determined that Tylenol enhancing pain killers are dangerous enough to potentially be pulled from the market. Drugs including Vicodin, Hydrocodone, Lortab, Maxidone, Norco, Zydone, Tylenol with codeine, Percocet, Endocet, and Darvocet may be permanently banned from the US market, even if the patient has a prescription from a doctor. The problem is the key ingredient — acetaminophen — can easily damage or destroy a patient's liver if more than 2000 mg are used per day. In many cases that means if you take a pain killer and then take two extra strength Tylenol, you may have gone over the maximum dosage per day."
As 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.
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.
Re:So too much acetaminophen can kill you? (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: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:So too much acetaminophen can kill you? (Score:1, Interesting)
And if I said that three beers a day will kill you within 5 years? Well, having been prescribed a standard prescription of vicodin which contains 500 mg of ace., 6 tables a day. You can do the math.
And this has been for 2 years for nerve damage. And yes, I have liver damage. I'm not a make believe TV doctor and I don't pretend to be one.
Re:not really a ban (Score:3, Interesting)
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.
Where is this 2,000 mg number coming from? (Score:2, Interesting)
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?
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, 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.
Re:As someone with a lortab prescription... (Score:1, Interesting)
And as someone with (a) chronic back pain and (b) a now-deceased drug addicted in-law, I'll chime in.
I need the Lortab. I use it sparingly, and try to halve the dose if I can (works about 1/3 of the time) because of the addictive potential and the side effects. (And I've seen & dealt with both at close range. It is not pretty).
But according to the now-deceased in-law, the Tylenol is in there exactly _because_ an overdose can kill you (or your liver). Generic Lortab et al are dirt cheap, and fairly readily prescribed. The Tynenol is the disincentive for the addict to take the drug. Which means they at least have to work harder to get another drug, or leach out the Tylenol from the Lortab.
Yes, taking too much can kill you. It's not a bug. It's a feature.
I'd rather see OTC Tylenol banned. There are other good OTC options. But what I'd really rather see is some in gov't stand up and tell people to READ THE LABEL. Remind them that they are responsible for their actions. Not that that will happen in the nanny state. (Soon to be a true ObamaNation).
Re:If You Drink Alcohol Avoid Acetaminophen (Score:3, Interesting)
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:This is not a ban (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 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.
Re:not really a ban (Score:3, Interesting)
With the combination, I would - at least sometimes - end up just coughing enough to clear things out.
You can't regulate stupidity and ignorance (Score:2, Interesting)
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?
Re:not really a ban (Score:1, Interesting)
For those of us allergic to NSAIDs and the like (including ibuprofen, aspirin, bufferin, advil, and pretty much everything except tylenol), banning tylenol is a problem. Amazingly, I've been taking tylenol in responsible dosages for years without liver damage. However, even children's aspirin and a number of those other fancy new painkillers all give me hives and leave me short of breath. Of course the article is not terribly clear as to whether acetominaphine itself would be banned.
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.
I think there's a bigger problem (Score:2, Interesting)
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.....
Allergic to acetaminophen (Score:2, Interesting)
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:not really a ban (Score:3, Interesting)
IMO neither of these drugs has sufficient warnings on them. The problem, as I see it, is that once you pass a certain threshold it isn't like you can just stop and your liver will fix itself. So maybe you take 15 200mg ibuprofen a day for 5 days thinking that it can't hurt you or if it does that you can just stop and be OK. When the truth is you may end up in a coffin. I'd like to see something like "exceeding the recommended dosage may result in irreversible liver failure and even death". The "irreversible" part is pretty important and is totally missing from the label.
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!
Re:not really a ban (Score:3, Interesting)
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 (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.
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.