Use Only as Directed(propublica.org)
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Use Only as Directed
http://www.propublica.org/article/tylenol-mcneil-fda-use-only-as-directed
11 comments
> I'd always assumed Tylenol in the US was functionally equivalent to Panadol in Australia
Your assumption is correct.
> I was surprised to learn Tylenol had a different active ingredient
??? It doesn't. Unless you mean it has a different name for the active ingredient.
Your assumption is correct.
> I was surprised to learn Tylenol had a different active ingredient
??? It doesn't. Unless you mean it has a different name for the active ingredient.
"So today I learnt that paracetamol is also called acetaminophen."
Side note, but I learned about the dangers of acetaminophen when I was on Vicodin while recovering from a major surgery a few years back. Back then, a lot of Vicodin tablets (and generics) had doses as high as 500mg of acetaminophen per pill, and I could have sworn I saw them go as high as 750 in some instances. (The FDA has since lowered the cap to 350, in light of the huge risk of liver damage).
The drug was almost banned from the U.S. market entirely in 2009, and not because of the hydrocodone. The acetaminophen is more deadly than the hydrocodone in the quantities consumed per day.
The drug was almost banned from the U.S. market entirely in 2009, and not because of the hydrocodone. The acetaminophen is more deadly than the hydrocodone in the quantities consumed per day.
The cynic might think that acetaminophen was added in such massive quantities with hydrocodone (Vicodin) and oxycodone (Percocet) [usually 500/50 ratios] as a way to discourage people from attempting to take more than the recommended dosage of opiates.
Kind of like how they used to put methanol into alcohol during prohibition, knowing full well it would kill some people, in an effort to scare people away from alcohol.
Even if that's not the case, it does seem reckless to put so much acetaminophen into each individual pill. I'd be very curious what percentage of those deaths were from overdoses on Vicodin and Percocet.
Kind of like how they used to put methanol into alcohol during prohibition, knowing full well it would kill some people, in an effort to scare people away from alcohol.
Even if that's not the case, it does seem reckless to put so much acetaminophen into each individual pill. I'd be very curious what percentage of those deaths were from overdoses on Vicodin and Percocet.
That's not cynicism, it's just realism. The drug companies don't want their product associated with drug abuse, so they add a megadose of something that eventually causes liver failure (acetaminophen). You get a lot of dead addicts, but fewer abuse scandals.
Acetaminophen doesn't actually reduce swelling (although it does reduce fever). Ironically, it's mostly... a mood-altering drug. http://www.theatlantic.com/health/archive/2013/04/whats-tyle...
Acetaminophen doesn't actually reduce swelling (although it does reduce fever). Ironically, it's mostly... a mood-altering drug. http://www.theatlantic.com/health/archive/2013/04/whats-tyle...
Do 500 mg or even 750mg sound that high?
Paracetamol (the non-US name of acetaminophen) here in France is usually available either in 500mg or 1g doses, and Wikipedia seems to say we had 6 deaths in 1990, and the number has been stable since then, so more than five times less than the US relative to population size.
So, I'm not sure that dosage is the most important factor here.
Paracetamol (the non-US name of acetaminophen) here in France is usually available either in 500mg or 1g doses, and Wikipedia seems to say we had 6 deaths in 1990, and the number has been stable since then, so more than five times less than the US relative to population size.
So, I'm not sure that dosage is the most important factor here.
It's not the dosage per pill that's unsafe; it's the concentration over a period of time. Acetaminophen builds up in the system.
I'd venture to guess that most acetaminophen/paracetamol users aren't popping Tylenol (etc.) every four hours for weeks at a time. But four Vicodin pills a day, taken over the course of a week or two -- not an unusual dosage for pain relief from major surgery or illness -- will concentrate an extremely large amount of acetaminophen in your system, because acetaminophen is eliminated fairly slowly from the body (and at great cost to the liver).
You're probably not going to kill yourself taking that much acetaminophen. I've done it a few times, and I'm still here. But you might do some serious, potentially irreversible damage to your liver. It's sort of like heavy metal poisoning: it takes a lot to get an acutely toxic dose, but a slowly toxic dose can accumulate over time.
I'd venture to guess that most acetaminophen/paracetamol users aren't popping Tylenol (etc.) every four hours for weeks at a time. But four Vicodin pills a day, taken over the course of a week or two -- not an unusual dosage for pain relief from major surgery or illness -- will concentrate an extremely large amount of acetaminophen in your system, because acetaminophen is eliminated fairly slowly from the body (and at great cost to the liver).
You're probably not going to kill yourself taking that much acetaminophen. I've done it a few times, and I'm still here. But you might do some serious, potentially irreversible damage to your liver. It's sort of like heavy metal poisoning: it takes a lot to get an acutely toxic dose, but a slowly toxic dose can accumulate over time.
How many grams in total do you get in a pack?
In a lot of Europe (certainly UK, I heard also France), you can only buy 16 pills (about 8g) at a time, unless your doctor writes you a ticket.
The pills themselves may contain a lot of chemical, but the whole pack doesn't contain enough grams for a successful impulsive suicide. You would need to go to a second drug store, by which time you'd probably decide not to do it. Hence the reduction in death rate.
The problem of liver damage due to chronic over use continues .
In a lot of Europe (certainly UK, I heard also France), you can only buy 16 pills (about 8g) at a time, unless your doctor writes you a ticket.
The pills themselves may contain a lot of chemical, but the whole pack doesn't contain enough grams for a successful impulsive suicide. You would need to go to a second drug store, by which time you'd probably decide not to do it. Hence the reduction in death rate.
The problem of liver damage due to chronic over use continues .
Right, I had not thought about this aspect of things, both the 500mg and 1g tubes I have at home contain a total of only 8g.
It doesn't seem difficult to accumulate more than 8g at home over time though, I'm not a big consumer of these and I have 12g at home, in three tubes. I remember my grand parents having a lot more packs at their place.
It doesn't seem difficult to accumulate more than 8g at home over time though, I'm not a big consumer of these and I have 12g at home, in three tubes. I remember my grand parents having a lot more packs at their place.
you can take acetaminophen 1gram ever 4 hours. So long as you don't do it for any length of time(1 week+), thats the issue. (Assuming your liver isn't comprised. )
If you keep to the NHS guidelines you'll be fine (http://www.nhs.uk/Conditions/Painkillers-paracetamol/Pages/I...)
your issue is that you had an opiod mixed in. That is where the "huge risk" is. Both opiates (especially ones like codine that require the liver to work) and acetaminophen (paracetamol) hammer you liver, which is fine so long as you don't take the piss.
Co-codolmol (the UK equivalent of vicodin ) is still available over the counter with a 8/500mg is available without prescription here in the UK.
update
Reading the article its very hard to see what point they are trying to make. The evidence they offer to suggest that its unsafe is vague. Prolonged exposure is bad, and almost doubling the dose is doubly bad.
The basic rule of thumb here for any medicine is this: READ THE LEAFLET. DON'T MIX AND MATCH. TALK TO A DOCTOR.
Most medicine is toxic, and if you double the amount you take bad shit happens. If you OD on codine you stop breathing, why is it a surprise that if you OD
If you keep to the NHS guidelines you'll be fine (http://www.nhs.uk/Conditions/Painkillers-paracetamol/Pages/I...)
your issue is that you had an opiod mixed in. That is where the "huge risk" is. Both opiates (especially ones like codine that require the liver to work) and acetaminophen (paracetamol) hammer you liver, which is fine so long as you don't take the piss.
Co-codolmol (the UK equivalent of vicodin ) is still available over the counter with a 8/500mg is available without prescription here in the UK.
update
Reading the article its very hard to see what point they are trying to make. The evidence they offer to suggest that its unsafe is vague. Prolonged exposure is bad, and almost doubling the dose is doubly bad.
The basic rule of thumb here for any medicine is this: READ THE LEAFLET. DON'T MIX AND MATCH. TALK TO A DOCTOR.
Most medicine is toxic, and if you double the amount you take bad shit happens. If you OD on codine you stop breathing, why is it a surprise that if you OD
Also the topic of the latest This American Life: http://www.thisamericanlife.org/radio-archives/episode/505/u...
Since it is Sunday and that's when they post the MP3s I listened to some of it today ... I had known of the dangers but had no idea how easy it was to get into dangerous territory. Interesting presentation as well.
Since it is Sunday and that's when they post the MP3s I listened to some of it today ... I had known of the dangers but had no idea how easy it was to get into dangerous territory. Interesting presentation as well.
I have little sympathy for people thinking "oh, it's safe, so it must be safe to take more than the maximum recommended safe dose", but that might be partially because I'm married to a nurse. If I try to be a little more objective about it, I suppose its sensible given how prevalent the drug is and how little you ever hear about people having problems with it- you wouldn't really assume that overdosing would be that dangerous.
When your pain is bad, it is tempting to just keep taking more drugs until it starts working, and everyone knows (er... everyone I know; again, probably biased 'cause married to a nurse) you're not supposed to take too much ibuprofen 'cause it's bad for your stomach, so might as well take tylenol. Fortunately, one of the genuine good features of acetaminophen is a lack of negative interactions with other drugs, so the safe way (as far as I know / have experienced, not a medical professional, don't take my advice, etc., etc.) to assuage that temptation is to vary the types of painkillers you use- little bit of ibuprofen, little bit of tylenol, and unless it gets really bad (at which point you should probably be seeing a doctor and not self-medicating anyway), that generally keeps you within safe limits for both (if you wanna add more types to the rotation, though, you do have to do some research and make sure that the additions don't cause bad interactions or have similar mixtures of active ingredients; e.g., if you take Aleve, that counts towards your total ibuprofen dosage limits).
When your pain is bad, it is tempting to just keep taking more drugs until it starts working, and everyone knows (er... everyone I know; again, probably biased 'cause married to a nurse) you're not supposed to take too much ibuprofen 'cause it's bad for your stomach, so might as well take tylenol. Fortunately, one of the genuine good features of acetaminophen is a lack of negative interactions with other drugs, so the safe way (as far as I know / have experienced, not a medical professional, don't take my advice, etc., etc.) to assuage that temptation is to vary the types of painkillers you use- little bit of ibuprofen, little bit of tylenol, and unless it gets really bad (at which point you should probably be seeing a doctor and not self-medicating anyway), that generally keeps you within safe limits for both (if you wanna add more types to the rotation, though, you do have to do some research and make sure that the additions don't cause bad interactions or have similar mixtures of active ingredients; e.g., if you take Aleve, that counts towards your total ibuprofen dosage limits).
Wow. But let's play along. Which other OTC medicines could being forgetful and accidentally taking a second dose cause death? Not to mention it's hidden in other medications which require careful label reading to discover. fta:
"The 4 gram per day recommended dose is also the maximum safe dose, one that
must not be exceeded, an unusual situation for any drug, particularly an OTC
drug, one placing a large fraction of users close to a toxic dose in the
ordinary course of use," the report said.
Where did you get the idea that an extra 1g dose can be fatal? "Maximum safe dose" does not mean "exceeding this dose once is fatal".
I don't subscribe to the belief that people deserve to die for not doing exhaustive research on the over-the-counter medications they take. You might want to rethink your position, since you apparently didn't do enough research yourself when you said that acetaminophen has "a lack of negative interactions with other drugs." Acetaminophen interacts with a lot of commonly taken drugs, such as alcohol, ephinedrine, and lomitapide, not to mention things that most people don't consider drugs like white grapefruit juice.
The reality is, unless you're a child or a teenager, you should just take aspirin. It won't damage your liver or give you an ulcer like acetaminophen or ibuprofen. And it is actually an anti-inflammatory, not just a fever reducer and mood-altering drug.
The reality is, unless you're a child or a teenager, you should just take aspirin. It won't damage your liver or give you an ulcer like acetaminophen or ibuprofen. And it is actually an anti-inflammatory, not just a fever reducer and mood-altering drug.
You might want to rethink your position
As far as interactions, you're right, it does interact with other drugs and non-drugs (the fact that lots of other OTC medications contain acetaminophen is also troubling, but a different issue in my mind), but in my experience as a guy who has to take a lot of painkillers and who's married to a nurse who takes care of figuring out what's safe, acetaminophen is one of the less worrisome drugs to deal with. On re-reading, I pretty clearly chose a bad way of expressing myself with the word "lack"- I meant "fewer" rather than "none at all"- so sorry about that, but with the appropriate disclaimers about don't take my advice, etc., I stand by my statements as regards my own experience- acetaminophen is very safe and very convenient when you don't overdose. Unfortunately, as I have just learned, it's really easy to overdose, and that's really sad and a big problem.
Aspirin does cause ulcers. If you have references showing that ibuprofen is more dangerous (or even differently dangerous) than aspirin I would be interested to see them.
That's a good point. I don't really have any hard information on which is more dangerous in terms of ulcers. I find conflicting information online. One thing is for sure: you should NOT take either aspirin or ibuprofen on an empty stomach. Always eat something first.
I tend to lean towards aspirin for a few reasons. It's older (100 years versus 30 years old) so we've had more time to figure out what other side effects it has, as well as interactions with other drugs. The blood thinning effect reduces the chance of heart attack or stroke (while it's in your system), which is always nice. There are some studies which seem to show that aspirin has anti-cancer properties, but I'm not sure if I believe them, because they have not proposed a mechanism of causation. Finally, ibuprofen seems to be sold in higher doses in general and have a more intense effect, which isn't really want I want. I just want something that does the minimum most of the time.
I tend to lean towards aspirin for a few reasons. It's older (100 years versus 30 years old) so we've had more time to figure out what other side effects it has, as well as interactions with other drugs. The blood thinning effect reduces the chance of heart attack or stroke (while it's in your system), which is always nice. There are some studies which seem to show that aspirin has anti-cancer properties, but I'm not sure if I believe them, because they have not proposed a mechanism of causation. Finally, ibuprofen seems to be sold in higher doses in general and have a more intense effect, which isn't really want I want. I just want something that does the minimum most of the time.
Do you understand that most people do not take painkillers for more than a few days at a time, and rarely at anything like the maximum daily dose?
You're worried about effects that occur with chronic high dosages. That's not the typical use-case.
You're worried about effects that occur with chronic high dosages. That's not the typical use-case.
You can kill yourself with Aspirin, in fact I thought that Aspirin was the #1 choice for that (without research). In any case, take too much and you are dead - I think not because of stomach ulsters, but because of bleeding in the brain. Again, that's just from memory, but google for it and you'll find some negative side effects.
I think there is also a problem in combination with other stuff, for example grape fruit juice.
(Edit: Googling for "aspirin suicide", find it in top 20 list of suicide methods http://wantdeath.blogspot.de/2011/07/method-5-of-suicide-asp... )
(Edit: Googling for "aspirin suicide", find it in top 20 list of suicide methods http://wantdeath.blogspot.de/2011/07/method-5-of-suicide-asp... )
You can kill yourself with almost anything, including water.
Did you read the article? The whole point of it is that the dose of acetaminophen found in many pills in the US is dangerously close to the level at which liver damage occurs.
The same can't be said for other painkllers.
Did you read the article? The whole point of it is that the dose of acetaminophen found in many pills in the US is dangerously close to the level at which liver damage occurs.
The same can't be said for other painkllers.
The reality is, unless you're a child or a teenager, you should just take aspirin.
For me ibuprofen is a miracle. I get bad headaches from time to time that aspirin and acitominphen have negligible impact on. Ibuprofen knocks them out completely.
For me ibuprofen is a miracle. I get bad headaches from time to time that aspirin and acitominphen have negligible impact on. Ibuprofen knocks them out completely.
I don't subscribe to the belief that people deserve to die for driving off the cliff. The reality is they should just take the bus.
I would not describe the ~40% of acetaminophen overdoses
in the US that are attempted suicides as "accidental".
http://onlinelibrary.wiley.com/doi/10.1002/hep.20948/pdf
http://onlinelibrary.wiley.com/doi/10.1002/hep.20948/pdf
One notable case in point was the suicide of Dr Bruce Ivins, senior biodefense researcher at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in Fort Detrick, Maryland.
By 2008, Ivins had found himself on the FBI's short list in the Amerithrax[1] investigation. No autopsy was ordered[2], due to the medical examiner's blood tests which revealed an overdose of acetaminophen and codeine.
[1]http://en.wikipedia.org/wiki/2001_anthrax_attacks
[2]http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aKQxd...
By 2008, Ivins had found himself on the FBI's short list in the Amerithrax[1] investigation. No autopsy was ordered[2], due to the medical examiner's blood tests which revealed an overdose of acetaminophen and codeine.
[1]http://en.wikipedia.org/wiki/2001_anthrax_attacks
[2]http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aKQxd...
Related: Fall in paracetamol deaths 'linked to pack limits'
Deaths from paracetamol overdoses fell by 43% in England and Wales in the 11 years after the law on pack sizes was changed, according to a study.
http://www.bbc.co.uk/news/health-21370910
Deaths from paracetamol overdoses fell by 43% in England and Wales in the 11 years after the law on pack sizes was changed, according to a study.
http://www.bbc.co.uk/news/health-21370910
I don't have any sources but I think education about paracetamol was improved too, most people seem to be aware of the risks to the liver and know not to take it when consuming alcohol.
While every death is a tragedy, 150 per year makes the phenomenon quite the outlier. For perspective, cancer takes over 500,000 lives a year in the US [1]. And lightning kills around 50 [2].
[1] http://www.cdc.gov/nchs/fastats/lcod.htm
[2] http://www.lightningsafety.noaa.gov/fatalities.htm
[1] http://www.cdc.gov/nchs/fastats/lcod.htm
[2] http://www.lightningsafety.noaa.gov/fatalities.htm
the difference, unlike cancer, is we know how to nearly completely prevent those 150/year (and 70k associated hospitalizations)... it's just it puts a big dent in a private company's earnings and we have the best congress that money can buy. fta
The German government reported four deaths from acetaminophen poisoning in
2010, the same year the CDC put the American total at 321. The U.S.
population is four times that of Germany.
Yet 85000 people die each year of alcohol abuse. Legalizing marijuana as a substitute for alcohol would save thousands of lives each year. I would pick my battles, this issue seems very minor in comparison to the real problems.
MDMA would be a much better substitute for alcohol, since it doesn't cause long-term cognitive impairment or lung cancer.
Of course, I don't encourage anyone to use drugs that are currently illegal, since what you're getting is not pure.
Either way, it's off-topic.
Of course, I don't encourage anyone to use drugs that are currently illegal, since what you're getting is not pure.
Either way, it's off-topic.
MDMA would be a much better substitute for alcohol
I think you are seriously misunderstanding the normal use case for alcohol.
I think you are seriously misunderstanding the normal use case for alcohol.
I'm not sure it has stricter controls (think you can buy it OTC, too, but not 100% sure), but it also has better health insurance for everyone. Perhaps that could be a factor - people are more likely to see a physician before overdosing on pain killers?
When using statistics, it needs to be done with more care. This is a typical example where the article fails to support its main argument because of not using statistics correctly:
> The amount of acetaminophen these patients had ingested was close to the recommended daily dose of 4 grams. The median was 6 grams per day — a surprise, because the toxic dose was thought to be between 10 and 15 grams, Erush said. She also found that most of these patients had other risk factors, such as chronic alcohol use.
That is like saying: The median speed in fatal accidents are 10% over the speed limit, with most involved drivers having other risk factors such as chronic alcohol use.
Without separating out the factors, we can't say how much higher risk of an fatal accident a 10% over the speed limit might cause. The information is simply not there. I would have liked that the article told me about the increased risk that 6 grams per day might give by itself. Combining 6 grams with alcohol is a bad idea, and is as obvious as being drunk and speeding. The article really shouldn't focus on those kind of scenarios, and it weakens the main argument they are trying to make.
> The amount of acetaminophen these patients had ingested was close to the recommended daily dose of 4 grams. The median was 6 grams per day — a surprise, because the toxic dose was thought to be between 10 and 15 grams, Erush said. She also found that most of these patients had other risk factors, such as chronic alcohol use.
That is like saying: The median speed in fatal accidents are 10% over the speed limit, with most involved drivers having other risk factors such as chronic alcohol use.
Without separating out the factors, we can't say how much higher risk of an fatal accident a 10% over the speed limit might cause. The information is simply not there. I would have liked that the article told me about the increased risk that 6 grams per day might give by itself. Combining 6 grams with alcohol is a bad idea, and is as obvious as being drunk and speeding. The article really shouldn't focus on those kind of scenarios, and it weakens the main argument they are trying to make.
That's why I buy ibuprofen instead. It's safer, except for someone who is pregnant.
Different use cases, surely? I tend to pick my painkillers according to the nature of the pain.
They seem equivalent to me as far as the type of pain.
How would you distinguish them?
How would you distinguish them?
Far more people in the US die of dehydration every year. I am not saying that we shouldn't try to save people dying from different causes, but please - people have to use at least basic common sense when ingesting drugs.
The problem is that for most people, with a drug that is massively advertised as "trusted by hospitals and doctors", taking a little more than prescribed when you're in a lot of pain IS basic common sense.
How does that work - they forget to drink and die?
Usually they have a gastrointestinal infection and lose fluid through diarrhea and vomiting, i.e. drinking doesn't help. If they don't get it via an infusion, it can be game over surprisingly quickly.
"You die of dysentry" isn't just a game quirk.
"You die of dysentry" isn't just a game quirk.
Interesting, although I wonder if "death by dehydration" would be the correct labeling of those cases.
Like if you are being stabbed through the heart, technically you die of heart failure.
Like if you are being stabbed through the heart, technically you die of heart failure.
When I started reading this article I was surprised to learn Tylenol had a different active ingredient, and almost tuned out to the warning because I've never encountered acetaminophen in the wild. But my linguistic assumption compelled me search further, and uncover the connection.