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...

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

[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

[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

[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

[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

[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]

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.

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]

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.

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.

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.

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: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.

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: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?

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: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).

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,

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.

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.

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.

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.