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At the heart of the FDA's new scrutiny of prescription painkillers is a chemical called acetaminophen (aka. paracetamol). The key component in Tylenol and other popular painkillers, it has caused many injuries to the liver, as the suggested maximum daily dose is just below the dosage levels that could cause serious organ damage.  (Source: Wikimedia Commons)

Acetaminophen toxicity in the liver proceeds via the red path (other common non-toxic metabolic pathways shown in blue).  (Source: Wikimedia Commons)

The FDA is considering removing from the market Nyquil and other drug cocktails which combine acetaminophen with other medications.  (Source: Procter & Gamble)
Many household names may seem serious changes

The U.S. Food and Drug Administration is considering serious changes that may impact the sales of prescription and over-the-counter painkillers. According to the FDA, there are over 56,000 acetaminophen overdoses per year in the U.S. alone. 

Acetaminophen is a leading painkiller found in Tylenol, Procter & Gamble's NyQuil, and Novartis' Theraflu among others.  The cyclic hydrocarbon derivative is also frequently combined with opiates or other pain relievers in medications such as Percocet (oxycotin+acetaminophen).  Overdoses can cause severe liver damage and even death.

The FDA began a two-day meeting starting today, polling 35 experts about what the best approach is to reduce the dangers of acetaminophen-related liver damage.  At issue are the current 4 gram-per-day maximum dose listings featured on many of the drugs, a dose just below levels which can cause potentially fatal liver injury.  The FDA says that by emphasizing safety, drug makers like Tylenol essentially mislead consumers into the belief that the drugs are "extremely safe and not likely to lead to serious injury."

Among the suggestions are to add "black box" warnings to certain drugs, pull others off the market, and to reduce the dosage in still others.  Such restrictions would be major blow to the pharmaceuticals industry, potentially costing it millions. 

Nyquil and Theraflu are among the combination drugs that some experts are suggesting get pulled off the market.  The FDA is concerned about consumers not realizing that these drug cocktails contain acetaminophen and taking Tylenol in addition, elevating their dosage to dangerous levels.

Still, the provisions may only go so far -- only five of the 72 deaths reported with acetaminophen in 2005 were from combination drugs.  Of the remaining, 40 deaths were caused by prescription acetaminophen drugs and 27 involved single-ingredient over-the-counter acetaminophen products, such as Tylenol.

A reported 28 billion doses of such products were sold in 2005.  The pharmaceutical industry is already pleading with the FDA to avoid making changes.  States the Consumer Healthcare Products Association, "These products provide consumers with effective pain relief and are safe and effective when used according to labeled direction."

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New labelling
By markitect on 6/29/2009 3:49:23 PM , Rating: 5
Here's my idea for the new labelling. Put a sticker on it that says:
Don't be an Idiot




RE: New labelling
By zsunjian on 6/29/2009 4:48:46 PM , Rating: 5
"Only two things are infinite, the universe and human stupidity, and I'm not sure about the former." -Einstein


RE: New labelling
By invidious on 6/29/2009 5:22:43 PM , Rating: 2
Darwin for president 2012.

If someone is dumb enough to kill themselves so easily do we really want them watering down our gene pool? We were not all created equally, why should we all suffer equally?

It is all too common that the voice of the masses is determined by the listening to the loud inept minority.


RE: New labelling
By Redfoot on 6/29/2009 4:51:29 PM , Rating: 5
There you go!

Besides, I wonder how many of these supposed overdoses are suicide attempts. Tylenol was the number 1 "suicide attempt" drug next to ibuprofen and tricyclic antidepressants in my ER 3 years running. Controlled or illicit drugs barely came into our unit. I swear we had 3-4 a week, normally consisting of a female, 14-23 y/o, mostly looking for attention (more serious attempts are made with harder drugs, or different means).

It was interesting to see their reaction that yes, they are fine for now, but that incalculable damage has been done to one of the most important organs in the body.

The point is that should we really stand in the way of natural selection? Being a self admitted geek and nurse, the acronym RTFM takes on a very special meaning. Most any OTC drug can be taken to unsafe levels by taking just a few pills over the recommended dosage.

On another note, my Pharm teacher was telling us how aspirin, if submitted to the FDA today, would most likely never be approved due to its many interactions and side effects, most notable being internal bleeding. Meanwhile it remains one of the 4 front line medications for the treatment of chest pain and suspected myocardial infarction upon initial admission, and it is prescribed to millions daily alongside their daily vitamins.

The FDA would be better served not pushing through the myriad of drugs that have been recalled in the past decade for more serious side effects than attacking proven, cheap, reliable medications that serve 99.999% of the population without incident.


RE: New labelling
By tmouse on 6/30/2009 8:35:29 AM , Rating: 3
I usually refrain from anything that could be perceived as a personal attack but if you truly believe in your statement:

quote:
should we really stand in the way of natural selection?


Maybe you should consider a change in occupation. A significant part of your job involves standing in the way of natural selection. Natural selection mandates the genetically inferior should not live long enough contribute to the gene pool, The vast majority of your patients who are in any life threatening situations should, by natural selection, die. While "many OTC drugs can be taken to unsafe levels" I recommend you talk with your pharm teacher about the percent LD50 of acetaminophen versus other compounds, plus the nature of its detoxification mechanisms. The point is acetaminophen containing compounds are flooding the market and while it is generally safe by and of itself it can be very hard for the general populous to keep track when so many drugs contain it. Now I'll agree some of the suggestions are a bit too harsh but others are quite frankly overdue. We have absolutely no way of really quantifying whether we are steadily damaging our livers by the constant stream of this compound we keep ingesting in its myriad of forms. Acetaminophen's safety is being grossly mismarketed to the point many think it is completely safe, when in fact there are many situations when it should not be used or the maximal dose should be far lower.


RE: New labelling
By CSMR on 6/30/2009 4:19:06 PM , Rating: 2
No, deaths from this are a often a result of depression not stupidity.


Don't punish the smart ones
By Spivonious on 6/29/2009 3:33:44 PM , Rating: 2
Those of us that can read already know that Nyquil contains Tylenol, and don't take more. Don't take away a working "drug cocktail" because some idiots didn't read the label.




RE: Don't punish the smart ones
By brybir on 6/29/2009 3:40:54 PM , Rating: 3
I think most of the problems that are occuring are because the public thinks that Tylenol and others are very safe drugs. And for the most part they are very safe, but they are unsafe at larger dosages.

So, instead of playing nanny state, just do what is required of other drugs. If their is a commercial on TV, then it needs to disclose the major risks that could happen by taking the drug. You see it on Viagra commercials when the guy says "may also cause bleeding, dizzyness etc..." so why not just have that sort of thing for Tylenol commercials. Then, on the boxes, put a big warning at the top that OD'ing causes liver damage.

Put the info out there, and then let reasonable consumers make informed choices. If I read a label that says "excessive amounts of this product may cause liver damage or even death" I bet I would think a bit harder about taking it.

Then again, their will ALWAYS be people that cant or will not read things and will hurt or kill themselves as a result. The rest of us should not be punished for the actions of those people when the informatino about safety is readily available.


RE: Don't punish the smart ones
By marvdmartian on 6/29/2009 4:24:53 PM , Rating: 2
Well, if you listen to Tylenol commercials, they really do push themselves as being the safer alternative, and brag that more hospitals/doctors promote Tylenol as having less negative interactions with other drugs.

That being said, I've always considered Tylenol (acetaminophen) to be fairly safe, so long as used resposibly.....just like any other drug. Personally, I use ibuprofen nowadays as a pain killer/headache relief, because most of my pains/headaches are muscular related, and ibuprofen works better as an anti-inflammatory.

I do sort of laugh at myself, though, as back in my drinking days, it was quite common for me to come home from a night at the bar/club, and take steps to ward off any upcoming hangover with a large drink of water, usually used to wash down 3 extra-strength Tylenols! Oh well, it didn't kill me!! (eyeroll)


RE: Don't punish the smart ones
By Noya on 6/29/2009 5:15:36 PM , Rating: 2
quote:
in my drinking days, it was quite common for me to come home from a night at the bar/club, and take steps to ward off any upcoming hangover with a large drink of water, usually used to wash down 3 extra-strength Tylenols!


Same here...and for lots of people I know.


By foolsgambit11 on 6/30/2009 4:43:19 AM , Rating: 3
Extra Strength Tylenol is 500mg, and the maximum daily dosage is 4g, so you'd have to take more than 8 in a day to overdo it. The directions call for taking 2 at a time (and, surprise, not more than 8 per day). Perhaps 3 at once could overload the liver and cause damage - especially after trashing it with alcohol. It's certainly not in keeping with the '* Take Only As Directed' on the label. But I doubt it's much of an issue. I'm sure people do it millions of times a month (I know I'm guilty), but there are only thousands of overdose cases a year.


RE: Don't punish the smart ones
By MikeO on 6/30/2009 5:13:13 AM , Rating: 3
quote:
and take steps to ward off any upcoming hangover with a large drink of water, usually used to wash down 3 extra-strength Tylenols! Oh well, it didn't kill me!!


...and to make it worse, any painkillers you take before going to sleep won't do jack sh*t for you in the morning. Hangover is caused by dehydration, so just drink lots of water before going to bed and then take the painkillers in the morning if your head still hurts.


Aceteominphen is something to worry about...
By sxr7171 on 6/29/2009 3:45:53 PM , Rating: 5
It's not just deaths, but severe liver damage. The label says don't take more than 8 in a 24 hour period. 8 tabs in 24 hours is actually very dangerous in itself, coupled with the slighest amount of alcohol or even by itself puts a patient in far more danger than a OTC drug ever should.

Everyone is different in their liver function and in their frequency of use of the drug. There actually needs to be an awareness that Tylenol can really hurt you in some situations.

If you are taking 2 every 4 hours as the label says you could be taking 6g that day. You will suffer from that dose. The warning merely says don't take more than 4 such does in 24 hours. Most people think, that it is merely an OTC and that going over once or twice is no big and that the label indicates a conservative safety margin.

In the case of Acetaminophen, IT DOES NOT. 4g is the 24 hour maximum PERIOD. There is no real margin with that 4g dose.

I would be really careful with Acetaminophen.




RE: Aceteominphen is something to worry about...
By omnicronx on 6/29/2009 5:13:28 PM , Rating: 2
quote:
coupled with the slighest amount of alcohol
I would not be surprised if this played a huge role. I tell my friends about not taking Tylenol before drinking all the time and none of them believe me. I am sure the would be singing a different tune if there was a warning on the bottle. Combine that with any heavy drinker and there is no telling what damage you could do to your liver.


By tmouse on 6/30/2009 8:11:09 AM , Rating: 3
Not only alcohol, ANY reactive metabolite that would be removed via conjugation with glutathione. As long as your glutathione reserves are ok the acetaminophens reactive metabolite N-acetyl-p-benzoquinoneimine will not cause necrosis. Problem is MANY things now contain acetaminophen and many of the times people using it may also be on other drugs. Now while acetaminophen does not directly interact with other drugs is shares this common detoxification pathway. While there are not that many deaths we really have no way of knowing how much liver damage is accruing over time. Fortunately the liver is only second to the integument in its regenerative capacity, but things like hepatitis, drug abuse and alcohol or even many "good" natural remedies (often containing complex phytotoxins that are metabolized into conjugates for excretion) can tax this ability and contribute to toxicity well below the maximal dose for acetaminophen.


By Lord 666 on 6/29/2009 5:18:12 PM , Rating: 2
Well said. To add to that, in comparison to ephedra, acetaminophen caused more deaths and tissue damage. Its about time FDA has gotten something correct.


Directions
By Slug on 6/29/2009 3:27:25 PM , Rating: 2
Seriously. How hard is it to read the directions on the bottle! I'd hate to see a great med like Nyquil taken off the market because of a relatively small number of morons.




RE: Directions
By Botia on 6/29/2009 3:32:51 PM , Rating: 2
It has gotten harder and harder to find directions on the bottles. Warnings are all over the place. I can tell you 1000 ways not to use drugs but it is nearly impossible to find how you are supposed to use them anymore. Sometimes the directions are hidden inside some flap that gets ripped off when trying to get past all the warnings.


APAP
By apc31981 on 6/29/2009 5:55:05 PM , Rating: 2
Overdose is an extremely common occurance and is (usually)an accident in my patient population.
I am a pharmacist at a geriatric hospital and we get the antidote ordered about once a week.
People don't realize that many opiod products contain APAP. For example, Lortab / Vicodin both contain 500 mg of APAP per tablet and Vicodin HP contains 660 mg. Darvocet contains 650 mg per tablet.
I would argue that for the vast number of people, 4000 mg is not "potentially fatal." The general consensus is about 10 000 mg is sufficient for that.
That being said, for many patients the max should be 2000 mg daily.
What the FDA needs to do is remove Darvocet from the market, and change the labeling on OTC products to BOLDLY display the APAP content of the front of the products.




RE: APAP
By AntiV6 on 6/30/2009 3:37:39 AM , Rating: 1
I was put on some Cephlaxin(generic) when I got jacked in the jaw at a party; that pill worked great.

I slept pretty much all day, but, it worked great.

I got some Lortab coming my way though when I get my wisdom teeth pulled. Gonna finally ketch up on my sleep after suffering through O.Chem and history this summer! haha


RE: APAP
By AntiV6 on 6/30/2009 3:53:07 AM , Rating: 1
Whoops...

The Doctor gave me Propoxyphene for pain. Cephlaxin to ward of any infections.

Hahaha


fail
By LRonaldHubbs on 6/29/2009 3:29:53 PM , Rating: 3
quote:
The FDA is concerned about consumers not realizing that these drug cocktails contain acetaminophen and taking Tylenol in addition, elevating their dosage to dangerous levels.

So in other woods they want to protect idiots that take medications without actually reading the usage instructions (instructions which detail the active ingredients and clearly state not to use the product in combination with other products including those same ingredients). Don't they have better things to do? And isn't it in society's best interest to just allow said idiots to overdose?




By ggordonliddy on 6/29/2009 7:55:02 PM , Rating: 2
Please be to deliver it post-haste.




All this will do
By FITCamaro on 6/29/2009 9:40:44 PM , Rating: 2
Is raise drug prices which Democrats will then blame on the drug manufacturers.




HST
By codeThug on 6/29/2009 10:03:38 PM , Rating: 2
quote:
We had two bags of grass, seventy-five pellets of mescaline, five sheets of high powered blotter acid, a salt shaker half-full of cocaine and a whole galaxy of multicoloured uppers, downers, screamers, laughers.... also a quart of tequila, a quart of rum, a case of budweiser, a pint of raw ether and two dozen amyls


I don't remember Thompson mentioning NyQuil.

Maybe they should remove the acetaminophen and replace it with ether...




Nice
By Zingam on 7/2/2009 1:14:34 AM , Rating: 2
Let the pain begin!




Which is it?
By mattclary on 6/29/09, Rating: -1
RE: Which is it?
By mattclary on 6/29/2009 3:17:10 PM , Rating: 5
Ahhhhhh... overdoses vs. deaths... Reading comprehension finally kicks in.


RE: Which is it?
By rs1 on 6/29/2009 3:34:23 PM , Rating: 4
It makes for some interesting math though. According to the article, there are 28 billion doses sold each year. Of those, there are 56,000 overdoses, and 72 deaths. If we assume that on average, each bottle of pills purchased contains 100 doses, then for each person buying a bottle of pills, there is a 0.02% chance of overdose, and a 0.000026% chance of death (or if you prefer, a roughly 1 in 800 chance of dying from an overdose).

Put in that light, acetaminophen doesn't look all that dangerous. Considering the amount of time, effort, and resources that goes into creating and enforcing new regulations, I think a more worthwhile target could be found, that would result in many more saved lives for the same amount of effort.


RE: Which is it?
By 1frisbee1 on 6/29/2009 3:43:41 PM , Rating: 4
The problem is that as an over-the-counter medicine, the pharma companies can't charge as much as for restricted ones. The pharma industry has been pushing this idea for quite a while but I thought the Obama administration would have had better sense than this.

Business as usual, lobbyists dictating policy, fear driving bad legislation and bad regulation....the numbers do not support this action (look at the number of deaths from hospital mistakes and it is 50x the deaths from these drugs).


RE: Which is it?
By Souka on 6/29/2009 4:11:41 PM , Rating: 2
I always wash down my 4hr dose (6 does daily) of Tylenol with a glass of Jack Daniels... what doesn't kill you, makes you stronger right? I must have a strong liver!

:)


RE: Which is it?
By GlassHouse69 on 6/30/2009 1:14:36 AM , Rating: 2
alcohol with tylenol cause permanent liver damage.

alcohol within 24 hours of taking a regular dose can also damage it.

I like tylenol a whole lot for fever. It does not upset the stomach, and works well to just fix pain + fever. Aspirin is good but it is an anticoagulant, kinda scary at times. Ibuprofren causes your feet to swell and muscles to weaken, also stops bone growth. It's a anti-autoimmune disease medication, very powerful and misused easily (as well as mildly addictive!)


RE: Which is it?
By Ardan on 6/30/2009 2:57:10 AM , Rating: 3
Whoa there. Actually, NSAIDs like aspirin, ibuprofen and naproxen are anti-platelet drugs, not anti-coagulants (yes, there is a difference). An example of an anti-coagulant is warfarin, not aspirin. True, aspirin thins the blood (as naproxen and ibuprofen do, but not as strongly) but it is *not* an anti-coagulant. A better term than anti-autoimmune would be 'anti-inflammatory' as well. While NSAIDs can inhibit bone growth, it doesn't just stop everyone's bone growth. Generally, it is recommended to avoid taking them for a certain interval after a bone fracture, lumbar fusion, etc. Also, NSAIDs are non-narcotics and are not addictive. As with other medications (like nasal sprays), you can get a 'rebound effect' in certain cases but they are not addictive at all.

Yes, fluid retention is indeed a possible side effect (none of my customers have had that problem, however). They do not, however, just simply weaken your muscles. A few studies over the years have shown it to inhibit protein synthesis after exercise, but they used the maximum possible daily dosage. Tests shown using the average amount usually taken for muscle pain revealed no decreased muscle growth compared to someone that had exercised but did not take it. It is possible to have troubles consistently taking it while you work out, but if someone needs to take it every single day, then they need to see a doctor.


RE: Which is it?
By omnicronx on 6/29/2009 5:06:30 PM , Rating: 2
All you are going to see here is a change to the maximum daily dosage. People are stupid and think they can pop as many Tylenol as they want, and that is just not the case. As the article mentions it is not the common mixture (usually with narcotics like heavy opiates) that are causing the most deaths, but non mixture drugs that you can buy at your local convenience store. It is very hard to OD on acetaminophen when mixed with something else such as codeine (such as T1/T3's), you would pass out from the codeine long before you would be able to take enough acetaminophen.

No lobbying is ever going to make an average joe go get a prescription, especially when other OTC painkillers such as Advil and Aspirin are still freely available. Sure they do not compare directly, but I think you are crazy to think someone is going to spend 10 times the money to get a prescription.

Furthermore if they actually disallowed large doses, it would cost the pharmaceutical companies billions of dollars in R&D to find a replacement. There is no way this could be offset by the few extra prescriptions coming in


RE: Which is it?
By mondo1234 on 6/29/2009 11:36:38 PM , Rating: 2
quote:
All you are going to see here is a change to the maximum daily dosage

I think you are right about that (hopefully). Completely taking away a cheap OTC drug would not be good for any healthcare system. Tylenol is useful not only as a painreliever, but as a fever reducer and often works better than ibuprofen. Unfortunately, there are many suicidals that OD on Tylenol as a cry for help - only to find out they mistakenly hit the terminal jackpot.

According to the Joker:
What doesn't kill you makes you stranger...


RE: Which is it?
By Gul Westfale on 6/29/2009 5:14:30 PM , Rating: 2
the chance of dying from an overdose is clearly 72 in 56000.


RE: Which is it?
By TomZ on 6/29/2009 10:46:20 PM , Rating: 2
...and the chance of having and overdose AND dying from it is 72 in 28 billion.

Frankly, I find it hard to understand why the FDA is considering a change. Let's focus on reducing other types of fatalities...there's a long list of things that are much more letal...like driving for example.


RE: Which is it?
By tmouse on 6/30/2009 9:00:25 AM , Rating: 3
Keep in mind that number is probably grossly underestimated. The majority of people who could die due to accidental OD would be the elderly. Most states do not require any blood tests or autopsies on any one who dies while under a physicians care within a certain time frame. Also anyone with any liver pathology would probably go unnoticed. The numbers are ONLY for reported deaths from accidental or deliberate overdoses that are reported by emergency rooms. Add to that we simply do not know the chronic effects of long term maximal dosage, and with this compound appearing in more and more drugs; reaching or slightly exceeding the maximal dose is becoming easier. Please note how many on this forum also mention taking it after using alcohol which is foolish and clearly written of the label. I agree bans are not necessary but the marketing of its safety is being grossly exaggerated.


RE: Which is it?
By cyriene on 6/29/2009 6:16:22 PM , Rating: 3
Acetaminophen is a pretty dangerous drug. Just because someone doesn't symptamtecally OD doesn't mean they aren't damaging their liver.
Add alcohol in to the equation and the liver damage is much worse.

People feel these drugs are safe because they are over the counter. Also, a lot of people will take more then the recommended dose, because if 2 is good, 4 must be better. There is a ceiling of effect where more drug does not produce benefits, but causes harm.

ibuprofen is another drug that is not as safe as people think.

The funny thing is, for chronic pain, someone would be better off taking a narcotic than acetaminophen or ibuprofen. But we have this mentality that narcotics are bad.


RE: Which is it?
By Gul Westfale on 6/29/2009 10:13:57 PM , Rating: 3
quote:
symptamtecally


wow. symp-tam-tec-all-y. wow. you've made my day. that is the most retarded american spelling (and don't pretend you're not from the US) i have seen since someone wrote "uphauled" instead of "appalled".


RE: Which is it?
By codeThug on 6/29/2009 10:46:08 PM , Rating: 4
uphauled is like keelhauled without the boat. Get a qlew.


RE: Which is it?
By Ardan on 6/30/2009 3:05:46 AM , Rating: 2
Ah, I wasn't the only one that thought of that I see :).


RE: Which is it?
By Gul Westfale on 7/1/2009 8:17:46 PM , Rating: 2
yes, but he was writing about how appalled he was by something, which made it funny.


RE: Which is it?
By Ardan on 6/30/2009 3:16:52 AM , Rating: 2
So they MUST be American if they spell a word wrong? Sure, the word was spelled quite badly, but you sure went overboard on your criticism of it. There are always a few people everywhere we go that don't spell as well as they should. I certainly have seen my fair share of spelling errors from people in other countries. I just simply let them know what the correct spelling is while refraining from hurling insults at them. A bit less arrogance also goes a long way, too. I'm sure that this message will be responded to with some form of hostility, though it is nice when people respond appropriately.


"People Don't Respect Confidentiality in This Industry" -- Sony Computer Entertainment of America President and CEO Jack Tretton









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