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http://www.propublica.org/article/tylenol-mcneil-fda-use-only-as-directed

by tokenadult • 13 years ago

36 45 13 years ago

propublica.org

gonzoisme• 13 years ago

150 or 1500?

bobbles• 13 years ago

It's 150 a year, but the post starts with 'during the last decade'

asveikau• 13 years ago

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.

jonnathanson2• 13 years ago

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.

byuu• 13 years ago

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.

cmccabe5• 13 years ago

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...

seszett2• 13 years ago

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.

shubb• 13 years ago

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 .

jonnathanson2• 13 years ago

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.

KaiserPro• 13 years ago

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

gliese13372• 13 years ago

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).

x0x02• 13 years ago

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.

that sounds like something extraordinarily dangerous to be handing out OTC and allowing companies to bury in other medications requiring people to be very careful to not accidentally double dose.

nknighthb2• 13 years ago

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".

cmccabe5• 13 years ago

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.

iopq2• 13 years ago

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.

waqf• 13 years ago

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.

veidr• 13 years ago

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.

Tichy4• 13 years ago

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... )

gliese13372• 13 years ago

    You might want to rethink your position

That was kind of my point. I should perhaps have been more explicit about it. I was unsympathetic, but, hey, now that you mention the problem and make me think about it, I can see how most people could have problems with this; while for me it's just plain obvious that you don't ever take more than the recommended maximum dose because you don't want to deal with side effects, other people do that with no expectation that death is a possible side effect.

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.

mattip• 13 years ago

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

x0x02• 13 years ago

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.

Germany has strict controls on acetaminophen.

iopq2• 13 years ago

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.

Tichy4• 13 years ago

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?

JacobAldridge2• 13 years ago

So today I learnt that paracetamol is also called acetaminophen. I'd always assumed Tylenol in the US was functionally equivalent to Panadol in Australia - ie, a brand name used in place of a drug name referring to the most common form of over-the-counter pain relief.

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.

ars3• 13 years ago

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.

JacobAldridge2• 13 years ago

"So today I learnt that paracetamol is also called acetaminophen."

dmckeon• 13 years ago

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

cynwoody• 13 years ago

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...

goggles99• 13 years ago

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.

Tichy4• 13 years ago

How does that work - they forget to drink and die?

brazzy2• 13 years ago

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.

brazzy2• 13 years ago

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.

ars3• 13 years ago

That's why I buy ibuprofen instead. It's safer, except for someone who is pregnant.

andrewaylett• 13 years ago

Different use cases, surely? I tend to pick my painkillers according to the nature of the pain.

ars3• 13 years ago

They seem equivalent to me as far as the type of pain.

How would you distinguish them?

gadders• 13 years ago

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

lewispollard• 13 years ago

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.

belorn• 13 years ago

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.

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