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September 23, 2013 5:19 PM   Subscribe

ProPublica.org and This American Life partnered for a special report on acetaminophen (also known as paracetamol), the active ingredient in Tylenol, which is also found in many other over-the-counter medications. The narrow therapeutic index of acetaminophen means that often, the difference between safe use and overdose can be as small as one gram. From ProPublica.org: "About 150 Americans die a year by accidentally taking too much acetaminophen, the active ingredient in Tylenol, federal data from the CDC shows."
posted by fiercecupcake (76 comments total) 26 users marked this as a favorite

 
And the lede which I internalized and forgot to externalize: McNeil, the makers of Tylenol and owned by Johnson and Johnson, has resisted strong safety warnings on acetaminophen while their internal documents and those of the FDA show that they have known for decades of the relative dangers of acetaminophen in relation to other OTC painkillers -- even while marketing Tylenol as "safe."
posted by fiercecupcake at 5:28 PM on September 23, 2013 [3 favorites]


[few comments removed. totally okay to rtfa folks.]
posted by jessamyn at 5:35 PM on September 23, 2013 [6 favorites]


This is an important pain killer with features not found in NSAIDs, such as not killing you from a gastric ulcer. However, it is not without its own dangers as discussed in the link. As with all medicines, proceed with care.
posted by caddis at 5:39 PM on September 23, 2013 [3 favorites]


Related: Ban Is Advised on 2 Top Pills for Pain Relief
A federal advisory panel voted narrowly on Tuesday to recommend a ban on Percocet and Vicodin, two of the most popular prescription painkillers in the world, because of their effects on the liver.
When people overdose on these, whether taking them for pain or recreationally, they are dying not because of the narcotic, but the acetaminophen they are bound to.
posted by modernserf at 5:40 PM on September 23, 2013 [22 favorites]


Pull-quote reads 150, first line of article reads 1,500 in a decade. Acetaminophen is pretty hepatotoxic. But it's also really good at relieving pain, and unlike opiates, it doesn't depress respiration. And since twenty billion doses are sold in the US a year, 150 deaths is about one death per 133 million doses sold. I really wonder what that figure looks like for other common drugs.
posted by gingerest at 5:41 PM on September 23, 2013 [12 favorites]


The long-term effects, vs OD, have finally been getting some attention. Quick Google
posted by Lesser Shrew at 5:49 PM on September 23, 2013


This is tragic, on many levels, but as someone who routinely surveys patients on OTC drug use (as well as other meds), Acetaminophen is hardly the only drug being misused to problematic effect.
Folks just pop pills til they feel better.
A good start would be to print warning labels and dosage instructions on all meds that look more like the safety instructions on airplanes -- big colorful pictures with pictures of mr. yucky next to the number of pills that would be too much (for every body weight).
but big pharma doesn't want folks to know that meds are toxic chemotherapy, they want people to think of meds as colorful magic healing tablets that do only good.
Now i routinely rely on pharmaceuticals to help me in my practice, mostly antibiotics (and resistance is a whole 'nother subject) and pain meds, so i am intimately familiar with how little the average person knows or cares about what they ingest, so long as it 'works'.
Tylenol, in fact, is not very good at relieving pain, because it's not an anti-inflammatory. it's used because it's gentle on the GI tract and it's not an anti-coagulant.
It is excellent at reducing fever, which is why it's given so often to small children.
posted by OHenryPacey at 5:50 PM on September 23, 2013 [6 favorites]


Tylenol, in fact, is not very good at relieving pain, because it's not an anti-inflammatory. it's used because it's gentle on the GI tract and it's not an anti-coagulant.

Which makes it essential to those of us with chronic pain who must avoid NSAIDs due to bleeding conditions and/or GI problems (I have both, because I am lucky). But yeah, it's not actually great at relieving pain -- god knows I'd prefer to take ibuprofen for that -- but it at least takes the edge off.
posted by scody at 5:55 PM on September 23, 2013 [9 favorites]


Christ. I take 3 upon waking every A.M. as a prophylactic before I do my morning workout. While not really an OD danger, I'm now a little fearful of the long term damage I may be doing.
posted by sourwookie at 5:57 PM on September 23, 2013 [1 favorite]


Acetaminophen is hardly the only drug being misused to problematic effect.

But a lot of people "misuse" it unintentionally. More than half the people who died in 2010 of overdose overdosed unintentionally. That's completely fucked up.
posted by rtha at 6:01 PM on September 23, 2013 [3 favorites]


My experience is that almost nobody -- and that includes a shocking number of doctors -- is aware of how dangerous Tylenol is compared to other OTC drugs. I personally know a person who nearly died because while his liver was failing his doctor told him not to worry about the 10-15 Tylenol he was popping a day for his back pain. When test after test failed to reveal the problem the doctor he finally went to for a second opinion asked about OTC drugs and said STOP DOING THAT NOW when S. mentioned the Tylenol. End of problem.
posted by localroger at 6:01 PM on September 23, 2013 [2 favorites]


Yeah, not good to take anything before working out. Exacerbates the damage. Tylenol is the only thing I can take, due to having weird allergic-type reactions to Advil, aspirin, and now, sadly, Naproxen. But, I have seen enough on the dangers to know what not to do.
posted by Windopaene at 6:02 PM on September 23, 2013 [1 favorite]


A federal advisory panel voted narrowly on Tuesday to recommend a ban on Percocet and Vicodin

Wow, that is one of the most sane things to happen in the Failed War on Some Drugs in a long time. I have long held the view that the only possible motivation for combining Acetaminophen with a potentially addictive second drug is pure sadism.
posted by localroger at 6:04 PM on September 23, 2013 [8 favorites]


Which makes it essential to those of us with chronic pain who must avoid NSAIDs due to bleeding conditions and/or GI problems

The fact that you know that you can't take NSAIDs means that you're not really the type of consumer/patient that the occasionally-proposed warnings or availability/packaging changes would be aimed at. Nobody is saying that acetaminophen is never the best tool for the job. Just that there are safer choices that should be ruled out first, and then if they're contraindicated for some reason, consider acetaminophen.

The controversy is over McNeil's careful positioning of Tylenol as a first-line, first-choice, "safe" pain reliever for everyone, all the time, to be washed down with roughly as much concern as table sugar -- maybe less. (And that's separate from the use of acetaminophen as an intentional denaturing agent alongside opiate drugs, which is misguided at best and evil at worst. However, that blame lies not with McNeil but with government regulators' decision to adopt a "harm maximization" approach to substance-management.)

There is a lot of room between what we have today, which is largely a creation of McNeil's marketing department, and taking acetaminophen out of the pain-control arsenal altogether.
posted by Kadin2048 at 6:07 PM on September 23, 2013 [9 favorites]


With strategic dosing of Acetaminophen in many (most?) opioid pain killers to discourage "misuse" (hey, with 650mg in some pills such as percocet, you CANNOT take two of them), this is my surprised face.

Many of these acetaminophen overdoses can be laid directly at the feet of the War on Drugs. Because heaven forbid you might need to take 2 percocets. We'd rather you destroy your liver and die a horrible death than take so much as a single extra pain pill.
posted by chimaera at 6:08 PM on September 23, 2013 [15 favorites]


Christ. I take 3 upon waking every A.M. as a prophylactic before I do my morning workout. While not really an OD danger, I'm now a little fearful of the long term damage I may be doing.

You might want to look into the research on how prophylactic pain killer use retards fitness gains and recovery.
posted by srboisvert at 6:12 PM on September 23, 2013 [5 favorites]


ProPublica produces the best quality investigative journalism, approached fearlessly, that I've witnessed in my 49 years.
posted by vapidave at 6:14 PM on September 23, 2013 [8 favorites]


Christ. I take 3 upon waking every A.M. as a prophylactic before I do my morning workout. While not really an OD danger, I'm now a little fearful of the long term damage I may be doing.

This is highly inadvisable on multiple levels. Not only are you needlessly subjecting yourself to serious side effects, but you are not accomplishing a thing vis a vis workouts; in fact, you are doing the opposite - you are diminishing the benefits of exercise and delaying recovery. I know that there's been a fashion to take OTC painkillers (usually ibuprofen) before workouts, but there's never been science behind that.
posted by VikingSword at 6:18 PM on September 23, 2013 [6 favorites]


ProPublica produces the best quality investigative journalism, approached fearlessly, that I've witnessed in my 49 years.

I've collaborated with their team on several projects now and they produce excellent primary sources and thorough research. WOULD MUCKRAKE AGAIN A+++!
posted by Mayor Curley at 6:23 PM on September 23, 2013 [19 favorites]


Every now and then I hear something about some new controls being proposed on acetaminophen, and it worries me that as I get older, some avenues of relatively easy relief may become more and more limited. I get that it's not a perfectly safe drug, and I understand that life will eventually kill me anyway, but I'd like for it to hurt a tad less in the meantime.
posted by sageleaf at 6:23 PM on September 23, 2013 [1 favorite]


You might want to look into the research on how prophylactic pain killer use retards fitness gains and recovery.

but you are not accomplishing a thing vis a vis workouts; in fact, you are doing the opposite - you are diminishing the benefits of exercise and delaying recovery.


Geez. I don't know anything. Thats good info. Thanks, guys.
posted by sourwookie at 6:26 PM on September 23, 2013 [2 favorites]


Caught this on the radio over the weekend. It's quite good, actually. Love ProPublica.

The big thing really is the labeling. Safe usage of acetaminophen is generally fine. The problem is the labeling is conservative and people (and even doctors - oof, that story of the little girl is heartbreaking) just ignore the warnings because of the aggressive marketing of Tylenol as super safe and basically benign. But it isn't benign. It's a drug. And like all drugs it has to be taken with caution.

I mean, growing up my friend's dad used to say when taking Tylenol, "if 2 is good, 6 must be great!" as he shoveled a mouthful of the stuff.
posted by Lutoslawski at 6:27 PM on September 23, 2013


I get that it's not a perfectly safe drug

There is no such thing as a perfectly safe drug. All drugs are toxins and all toxins are drugs. You can indeed kill yourself with Aspirin or Ibuprofen.

However, for most people who don't have a special sensitivity, it is a hell of a lot harder to kill yourself accidentally or otherwise with those other drugs. I don't think anybody wants Tylenol taken off the market or even subject to the kind of restrictions we place on things like alcohol. But people need to know that if you do something stupid with this thing you will die. Most people have been deliberately prevented from knowing that by the manufacturer, who does not want customers opting for possibly safer alternatives.
posted by localroger at 6:28 PM on September 23, 2013 [1 favorite]


vapidave: "ProPublica produces the best quality investigative journalism, approached fearlessly, that I've witnessed in my 49 years"

I love ProPublica. Love the work they do. The design on this story in particular, though, is giving me some pause. The count-up clock since the regulation deadline from the FDA? Quotes from victims' parents in the sidebar like "Death is never an acceptable side effect"? A lot of this feels emotionally manipulative in a way that makes me super uncomfortable.
posted by Apropos of Something at 6:28 PM on September 23, 2013 [1 favorite]


A lot of this feels emotionally manipulative in a way that makes me super uncomfortable.

That's the TAL contribution (and I love TAL but, you know, it's got a Thing).
posted by Lutoslawski at 6:30 PM on September 23, 2013


I was puzzled by the whole Vicodin thing for years and years, never could find an answer. I finally managed to put the pieces together a few months ago by accident. It has to do with the DEA schedules of drugs. By combining acetaminophen with hydrocodone you bump the opiate down a schedule, making it a hell of a lot easier for doctors who aren't licensed in pain management (gross oversimplification, forgive me) to prescribe it.

Thus your ob-gyn or your surgeon can give you a prescription for Vicodin with very little fuss, whereas it would be a hell of a lot more paperwork for straight hydroxycodone or whatever the kids are using these days.

But it's always fun to look at rare side effects. Aspirin has a small chance of killing your kid, or triggering asthma, or destroying your immune system if memory serves me. It also permanently disables a small portion of your platelets. Ibuprofen and other NSAIDS can destroy your stomach and kidneys. Acetaminophen handily destroys livers like it's going out of style, but on the flip side it may share some molecular characteristics of THC in the brain.
posted by hobo gitano de queretaro at 6:30 PM on September 23, 2013


Gingerest, the low number of fatalities does a disservice illustrating the true cost of acetaminophen overdose. Failing to rise above the mortal threshold are thousands of ED visits and hospitalizations each year due to overdoses most of which, as rtha notes, are unintentional-- 100% preventable. The UK got on this pretty early by restricting the number of pills per pack, and managed to decrease by almost half the number of deaths per quarter attributable to unintentional APAP overdose, which was already quite small compared to the US (30% in the US compared to 8% in the UK as of a decade ago). (Here's February's BMJ write-up on the program).

For those science nerds who are interested, here is a great (free) review article dealing with the mechanism of liver injury in the setting of acetaminophen overdose. WHO LIKES CYTOKINES?

chimaera: "Many of these acetaminiphen overdoses can be laid directly at the feet of the War on Drugs. Because heaven forbid you might need to take 2 percocets. We'd rather you destroy your liver and die a horrible death than take so much as a single extra pain pill."

About a year ago, I had the same thought you did and looked into it. As it happens, smart folks with a taste for prescription opiates tend to do their own cold water extractions, and the vast vast vast vast majority of opiate deaths are directly related to respiratory depression. Here's an interesting paper from 2010 suggesting that co-administration of opiates may actually speeds up metabolism of APAP. Just for scale, we should note that prescription opiates killed 14,800 folks in 2008-- about a hundred a day.
posted by The White Hat at 6:35 PM on September 23, 2013 [5 favorites]


Quotes from victims' parents in the sidebar like "Death is never an acceptable side effect"? A lot of this feels emotionally manipulative in a way that makes me super uncomfortable.

If you had a relative who died from a single dose of something you'd been led to believe was as safe as table sugar you might be a little upset too.

Stupid drug idea #1: Back when I was young, poor, uninsured, and had a massive toothache, I took seven grams of Aspirin in a twelve hour period. Killed the pain, my iron stomach had no problem with the acidity, I managed not to bleed out, and I'm still here. (I did look up the side effects and had some idea what I was doing. I was ready to dial 911 if it went south.) If I had done that with Tylenol I would be DEAD.

Supid drug idea #2: Before I got my pre-diabetes under control via diet, I was having regular (as in monthly) attacks of Gout. None of the usual precautions worked and none of the OTC pain relievers were worth a damn. I happened to mention this one day to a doctor acquaintance and he said "even Ibuprofen? How much did you take?" when I said "the maximum, 800 mg a day," he laughed. "No, no, for gout the starting dose is 3 doses of 800 mg. Just watch for gastric distress, you'll know quickly if it's a problem, and if you need to ramp it up more make sure a doctor is monitoring you." I answered gout with that dose of Ibuprofen for two years before finding the root cause. If I had done that with Tylenol I would be DEAD.

Tylenol is not like other OTC drugs. It is much more dangerous and people need to know that they cannot treat it the same.
posted by localroger at 6:37 PM on September 23, 2013 [9 favorites]


Listening to the show last weekend (one of the few times I've made time for TAL recently) the major thing that struck me about it all was the incessant insistence from McNeil that the overwhelming majority of ODs where from people trying to commit suicide, well that and the fuckupedness of children's vs infant's Tylenol. Outside of those two pretty serious things there certainly seems to be an element of almost willful consumer ignorance.
posted by edgeways at 6:40 PM on September 23, 2013


The onus shouldn't be on average people to understand this stuff. The products should just work. If I'm not allowed enough tyelnol OR enough ibuprofen to make it feel better then what the F am I expected to do? If they would just cure menstrual cramps the demand for these stupid pills would go down considerably.
posted by bleep at 6:46 PM on September 23, 2013 [2 favorites]


The onus shouldn't be on average people to understand this stuff.

I heard this story when it was on the radio also. I think this is the argument that they were making, you're correct. There should be clear warnings on the package that having not that much more than usual could actually directly lead to liver damage and, potentially, death. This is a known thing. And McNeil's response was basically to imply that people who died from Tylenol were mostly trying to commit suicide. It's not so much that the labeling won't happen eventually, it's that this is not the response you'd expect from people who are like "Oh no we are trying to be totally out in front of this" as McNeil are claiming.
posted by jessamyn at 6:51 PM on September 23, 2013


Tylenol is not like other OTC drugs. It is much more dangerous and people need to know that they cannot treat it the same.

The part of the story that gave me the most pause was how many other drugs--that are often taken together--have acetaminophen in them. So while you might have a handle on how much Tylenol you're taking, you've forgotten to include the dosage that's in your Mucinex and the cough and cold remedy you're also taking.
posted by gladly at 6:54 PM on September 23, 2013 [5 favorites]


The products should just work.

Unfortunately, tools have pretty much never worked like this at any time in all of human history. Tools have limits and dangers which must be respected. Drugs are powerful tools but they are not magic talismans of just-workingness. They powerfully interfere with natural processes in ways that can be both useful and dangerous. If the onus is not to be on you to understand the danger, then the drug needs to be prescription-only so someone who does understand the danger can keep track of it for you.
posted by localroger at 6:57 PM on September 23, 2013 [4 favorites]


Once upon a time, a, um, friend of mine was super depressed and impulsive after getting fired. That, er, friend came up with the idea of taking 20+ pills of whatever was around with whatever booze was around as a chaser. Fortunately, this combination just made this person throw up repeatedly for several hours. So it was a little scary to see that if this person happened to take more Tylenol, things could have ended up much differently.
posted by kat518 at 7:02 PM on September 23, 2013 [3 favorites]


Acetaminophen is, in fact, the safest oral OTC painkiller when used as directed. That’s why it is and should remain first-line therapy for pain. Far more people die per year from GI bleeds caused by NSAIDs. We’re talking thousands, not hundreds. And gastrotoxicity from NSAIDs can occur even at normal, recommended doses. In contrast, no one without existing hepatic dysfunction is going to die from using acetaminophen at recommended doses.

Read the box. Follow the directions. Ask your pharmacist. Use common sense.
posted by dephlogisticated at 7:05 PM on September 23, 2013 [8 favorites]


Tylenol, in fact, is not very good at relieving pain, because it's not an anti-inflammatory.

I think you're oversimplifying. Acetaminophen *is* a good analgesic - it blocks nociceptive receptors peripherally, which is pretty effective on non-inflammatory pain (like incisional pain). Because its action on prostaglandins is central (kinda mysterious, too), it's not nearly as fast-acting or effective an anti-inflammatory as the NSAIDs, so it doesn't do as good a job on pain secondary to inflammation. But it has its place in relief of both acute and chronic pain.

I'm worried that this is going to result in more professionals and patients undertreating pain. The narrow therapeutic ratio for acetaminophen bears much more monitoring than the drug gets, it's absolutely true, and McNeil's attitude is reprehensible, but I really hope this doesn't result in damage to availability of this incredibly clinically valuable medication.
posted by gingerest at 7:06 PM on September 23, 2013 [5 favorites]


dephlogisticated, you may be right -- although I suspect the death rate from gastric bleeds is highly inflated by situations that are very different from one-off Tylenol overdoses, but whatever. The thing is, people aren't warned that failing to follow the instructions will kill them. "If two is good, six is better," quoted upthread, is a very very common attitude.

With Tylenol two can be good and six will kill you. And the fact that people don't realize that is killing them.
posted by localroger at 7:10 PM on September 23, 2013 [2 favorites]


I'm lucky I didn't hurt myself taking it daily for anxiety routinely. Not long ago, I had a rough period where I was very anxious during the daytime. I needed help with my nerves during the workday, and I'd read that acetaminophen is an anxiolytic, so I went for it.

This was dumb. I'm glad that I mentioned it to my doctor, and he told me to stop before I got hurt. But what if I hadn't been able to afford to see a real doctor, and kept using Dr. Internet instead?
posted by Countess Elena at 7:12 PM on September 23, 2013


Far more people die per year from GI bleeds caused by NSAIDs. We’re talking thousands, not hundreds.

Found this hard to believe, but ahoy, you're right. More than 3,000 a year.
posted by Lutoslawski at 7:12 PM on September 23, 2013 [4 favorites]


Lutoslawski, the major difference is that you can feel gastric distress. You cannot feel what Tylenol is doing to your liver until it is far too late.
posted by localroger at 7:18 PM on September 23, 2013 [2 favorites]


Actually, many gastric bleeds do not cause pain—because, hey, you're taking a painkiller. That's why a good doctor or pharmacist will tell you to look for black, tarry stools.

Also, since we're on the subject, if you're going to kill yourself, please don't use acetaminophen. Dying from liver failure takes days, which gives you plenty of time to realize that you don't actually want to die anymore. But if you aren't given n-acetylcysteine (the antidote) within a certain window, there's nothing that can be done to reverse the effects, so your family gets to watch you die slowly in the hospital. Don't do that.
posted by dephlogisticated at 7:24 PM on September 23, 2013


I felt real reassured that ah, apparently nobody really knows how much is too much to take. That's real helpful. Especially if the borderline is pretty vague and easy to overdo?

I take Excedrin or Excedrin ripoffs pretty frequently, but I've never taken more than three in a day, which is what I think it said was the limit on the bottle. Today I had a headache while listening to this, and I felt all kind of shitty at the idea of breaking into my bottle of Safeway-ripoff and trying to do something about it.

For the record, that label says:

"Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
* with other drugs containing acetaminophen.
* more than 8 tablets in 24 hours, which is the maximum daily amount."


EIGHT?!
posted by jenfullmoon at 7:26 PM on September 23, 2013


EIGHT?!

That's the 24-hour maximum. The directions (assuming regular strength Excedrin or generic equivalent) also say 2 tablets per 6 hours (i.e. 8 per 24 hours). That's actually a fairly low dose of acetaminophen (assuming 250mg per tablet). Extra-strength Tylenol is twice that, but Excedrin also contains aspirin and caffeine.

the difference between safe use and overdose can be as small as one gram.

For perspective: that's 2 extra-strength Tylenol (i.e. 2 500mg pills), or twice the maximum dosage directed on the packaging.
posted by jedicus at 7:34 PM on September 23, 2013 [1 favorite]


With Tylenol two can be good and six will kill you.

I had the worst cold ever last winter - so much worse than my usual "sniffle and cough for a couple day, feel kind bleh, then...done!" kind of cold. I ached, I coughed, I sneezed, I couldn't breathe if I lay flat, my head hurt, blahblahblah. I was taking so much more OTC stuff than I usually do for colds and it was not that fun to try to keep track of which had Tylenol and which didn't, and in what quantities for the doses I was taking, etc.

I don't have any blood disorders, so taking too much ibuprofen over a period of a few days is really unlikely to give me any trouble. But between the daytime cough medicine and the nighttime cough medicine and whatever for my nose so I wasn't dripping everywhere and somethingsomething for my headache - it would have been terribly easy to OD on acetaminophen just by losing track of an extra dose of [cold med for symptom] if I hadn't forced myself to really watch it.
posted by rtha at 7:34 PM on September 23, 2013


Actually, many gastric bleeds do not cause pain—because, hey, you're taking a painkiller.

D'OH. Okay I had not thought of that, and it undoubtably explains why the mortality rate is so high. But it also still only affects a minority of people who are sensitive, as opposed to Tylenol which will kill anybody who takes a gram too much.
posted by localroger at 7:43 PM on September 23, 2013 [1 favorite]


modernserf: "Related: Ban Is Advised on 2 Top Pills for Pain Relief
A federal advisory panel voted narrowly on Tuesday to recommend a ban on Percocet and Vicodin, two of the most popular prescription painkillers in the world, because of their effects on the liver.
When people overdose on these, whether taking them for pain or recreationally, they are dying not because of the narcotic, but the acetaminophen they are bound to.
"

I note that they don't mention what those the millions of people who need those drugs, and have managed to not-od themselves by following directions, are supposed to do when they just ban them, rather than say...reformulating. Most people can't find, or afford pain specialists. They've been all but hounded out of practice by puritans who attack pain relief as a moral failing.

I agree that there isn't any reason for acetaminophen to be in everything. But banning the most common, very inexpensive, low dose, virtually non-addictive if directions are followed, painkiller on the market just because it has acetaminophen in it, is going to make a whole lot of people suffer needlessly.
posted by dejah420 at 7:47 PM on September 23, 2013 [10 favorites]


as opposed to Tylenol which will kill anybody who takes a gram too much.

That's false. A 1 gram overdose can be fatal in unusual circumstances, but it isn't necessarily so:
Minimum toxic doses of acetaminophen for a single ingestion, posing significant risk of severe hepatotoxicity, are as follows: Adults: 7.5-10 g
7.5g is 15 extra strength Tylenol, or 13 pills over the maximum directed single dose. It's almost twice the daily maximum.

There can rarely be fatal or dangerous side effects from smaller overdoses (particularly in people with pre-existing liver problems), but most people are not two extra Tylenol away from certain death.
posted by jedicus at 8:05 PM on September 23, 2013 [1 favorite]


virtually non-addictive if directions are followed

Newsflash: People don't follow the directions. Get over that and try to stop killing them because they think if two is good six is better.
posted by localroger at 8:06 PM on September 23, 2013 [1 favorite]


A 1 gram overdose can be fatal in unusual circumstances

/pedantfilter. Okay how about a 4 gram overdose, which is a very easy thing for someone who hasn't read the label and thinks the first gram did a world of good and of course they're OTC so harmless as candy?
posted by localroger at 8:08 PM on September 23, 2013


If you make it so that I have to start typing in people's drivers license info when they buy acetaminophen, I swear to God people, you and me are going to have words.
posted by dephlogisticated at 8:14 PM on September 23, 2013 [4 favorites]


I note that they don't mention what those the millions of people who need those drugs, and have managed to not-od themselves by following directions, are supposed to do when they just ban them, rather than say...reformulating.

There's not really any need to reformulate them.

Percocet users could just take oxycodone, and vicodin users could just take hydrocodone. If they need it, they could also be prescribed acetaminophen. Just not in the same pill.
posted by ROU_Xenophobe at 8:18 PM on September 23, 2013 [6 favorites]


> There's not really any need to reformulate them.

But, but, PROFIT:
Ask patent lawyers about expiration and the need to reformulate ....
posted by hank at 8:34 PM on September 23, 2013 [1 favorite]


But Rou, as was mentioned above, if the drugs aren't blended with something else, then they get bumped up a notch on the drug scale list, and most doctors won't prescribe them, because prescribing stuff on the top end of the drug scale gets you investigated regularly. The only doctors who regularly prescribe stuff at the top end of the drug chart are pain specialists. There are very few pain specialists, and almost none outside of major metropolitan areas.

Just using Texas as an example, a pain management clinic may not operate in Texas without obtaining a certificate from the Texas Medical Board. Malpractice rate prices for pain management clinics are exorbitant, and most GPs and Internists do not want to deal with the requirements necessary to maintain the certification. All patients which now see a regular doctor/internist/neurologist, will have to be shunted into another practice which only handles writing their prescription, thereby necessitating two different health care providers to do what a single healthcare provider does now. It will be a massive waste of both time and resources for the patient. And that assumes that they live anywhere near a pain specialist, which, again using Texas as an example, means that if you're not near Dallas, Houston, Austin (or Waco if you've got cancer), you're fucked. You could be two hours away from a doctor who can legally prescribe medication for you. And recent law changes on hydrophone don't allow for automatic refills, mean that you might have to make that trip every single month.

localroger, I've no idea what "Newsflash: People don't follow the directions. Get over that and try to stop killing them because they think if two is good six is better." even means.

Are you suggesting that I'm killing people because I take pain killers for my almost crippling medical issues? Because, what? I really have no idea how to parse your sentence, nor do I understand why you're so eager to see people like me live in crippling pain because other people are stupid. If we get to ban everything that stupid people use to kill themselves, we should start with beer, and anyone who says "Hey, y'all, watch this."
posted by dejah420 at 8:35 PM on September 23, 2013 [11 favorites]


I drink regularly, and as such I will not take acetaminophen. Ever. Naproxen works fine for me, and I can layer aspirin on top of that if required (only twice in my life has it been required).
posted by hippybear at 9:07 PM on September 23, 2013 [1 favorite]


How many people OD'd on pot this year?
posted by empath at 9:26 PM on September 23, 2013


And recent law changes on hydrophone don't allow for automatic refills, mean that you might have to make that trip every single month.

Exactly. I also take Percocet regularly -- but not as regularly as I actually should to stay on top of my pain, because I often take half of the dose I need in order to stretch out my Rx as long as possible, because of the hoops that I have to jump through to get refills (any Rx written with an automatic refill is rejected; faxed or phoned in refills are rejected; only hard copies of Rx's for a one-month supply are acceptable).

It regularly varies somewhere between pain in the ass and wild goose chase to get my refills, and I live in a major metropolitan area with most of my doctors located within a few miles of me. I can't imagine how hard it must be for people who live outside big cities, or how much more difficult it would be to get hydrocodone alone. (But hey, at least all these restrictions have led to a more successful War on Drugs!)
posted by scody at 9:30 PM on September 23, 2013 [2 favorites]


How many people OD'd on pot this year?

There is no determined LD-50 for THC.
posted by hippybear at 9:32 PM on September 23, 2013 [1 favorite]


I...really don't like this episode. At the crux, the argument seems to be that we need to better protect people who don't read the instructions coming with their medicine. And while I'm totally for better education, and I feel great sympathy for people who've suffered as a result of not understanding the medicine they're taking, how do you not understand the medicine you're taking?

And I don't even mean at a low level. It boggles my mind that someone wouldn't take a few seconds to read the recommended and maximum dosage printed on the bottle. And that their failure to do this is somehow not their fault. You're taking drugs, how do you not do the basic amount of work to protect yourself?

The later parts of the episode, regarding infant vs. baby formulations and the lack of any such dosage instructions are a huge problem though. My only explanation for why McNeil wouldn't just add instructions to the bottle (barring legal ramifications that I don't know about) would be that if their competitors don't as well it could affect sales in some manner. Which is scummy, but that's the whole reason we have the FDA. If anyone is to blame for this whole thing, I'd think it's them.
posted by karanlyons at 9:41 PM on September 23, 2013 [1 favorite]


It boggles my mind that someone wouldn't take a few seconds to read the recommended and maximum dosage printed on the bottle. And that their failure to do this is somehow not their fault. You're taking drugs, how do you not do the basic amount of work to protect yourself?

But like I said above, it's not always just reading the one label. It's reading multiple labels on multiple meds, which you're taking together - not even "six different pills at one time," but "I took a dose of the cough and ache syrup at 10 am, and that's got [some amount] of acetaminophen, then I took a dose of [other OTC med] that has [other amount] four hours later, then four hours after that, I took med 3 that *also* has acetaminophen" and so on. I don't remember any of the labels (and I read them because I already knew too much acetaminophen is dangerous) warning "Hey, are you taking more than one thing for this heinous cold? Check to make sure you're not over the safe recommended dose of this thing that can wreck your liver or maybe kill you, because it show up in a lot of the cold meds you're taking!" You're not always just adding up a neat little number of four Tylenol = X number of grams.

When you're already feeling pretty shitty and you just want the fucking coughing to stop already so you can sleep, I can see how it would be really easy to forget the dose you took earlier, or just be incapable of doing the math correctly.
posted by rtha at 10:09 PM on September 23, 2013 [7 favorites]


One thing not mentioned here (haven't listed to the episode yet to know if this is there) is ODing because you can't remember how much you took. Specifically, the pain blinding your ability to remember how much and when you took it last. Before I got proper migraine treatment, I know there were days I constantly downed excederin migraine (with acetaminophen) and sometimes would forget if I just took it or if I was planning on taking it and hadn't yet. I'm sure there were times I double dosed. Fortunately it must have been under the amount needed to kill me.

I eventually realized that was a fire I didn't want to play with, so I would keep a log of what I took at what time. But I think I'm probably in the minority. I did the same thing with percocet after a surgery, for a similar reason. It made me of loopy that I couldn't remember when I took it last.

One thing I'd love to see is pill bottles which displayed the last time the bottle was opened. It wouldn't necessarily tell you how many you took, but at least you'd know whether enough time had passed for another dose.
posted by [insert clever name here] at 10:13 PM on September 23, 2013 [3 favorites]


Have you even tried to read OTC medication labels lately? They are completely indecipherable. The actual dosage and stuff is buried WAY down in the label, often I have to look 3 or 4 times to find it. I mean, look at this. And with many things I buy, this runs over several "pages", not in a single column like this.

Drug labeling should be simple and straightforward. At the top should be dosage information. How much, and how often. After that should be warnings, spelled out explicitly. "If you take too much of this, you will have liver failure." That's probably too simple a wording, but yeah, that blunt. "Taking more than the described dosage may result in diarrhea" would be an excellent warning for naproxin sodium (Aleve). Because that is a fact. Etc etc etc.

The active and inactive ingredients should be listed on a separate label/section which is made to resemble food labeling, because everyone is practiced in reading that kind of thing.

Seriously, current OTC drug labeling is an exercise in obfuscation. Make it clear, make it obvious. Use different sizes of type. It isn't hard to create something which is easily scannable -- that current "modern" label simply is not.
posted by hippybear at 10:19 PM on September 23, 2013 [8 favorites]


You know hippybear, i swear growing up the dosage info was easier to find. Maybe I'm crazy, but it seems like it's obfuscated in an attempt to make you read the other info. I could swear those that dosage used to be easy to find and stood out more. I can't say at what point I noticed the switch. I am thinking the 80s or 90s. Does anyone else remember this?
posted by [insert clever name here] at 10:27 PM on September 23, 2013


20 billion doses.
150 deaths.
One death per 133 million doses.

I'm not seeing the problem here. You could plaster the box with skulls and make me sign a waiver and I'd still take those odds. Seriously, I'm twice as likely to win Powerball with a single game.
posted by obiwanwasabi at 1:15 AM on September 24, 2013 [2 favorites]


20 billion doses.
150 deaths.
One death per 133 million doses.

I'm not seeing the problem here.


Well, it's not just deaths from acute toxicity. Left out of most of the discussions are the people who are cumulatively eroding their liver function and consequently their health.

Beyond that, there's the principle of what constitutes a safe drug. "Number of deaths caused" isn't the only metric used in public health to evaluate a drug's safety. The main issue is that the difference between a therapeutic and toxic dose is so small that acetaminophen might not constitute what should be considered a safe drug.

Most people know that it has a potential for toxicity, but are not aware that said toxicity is so close to the recommended amount. I don't think I want to see it removed from the shelves, but I'm glad that someone is making the public aware that acetaminophen is not the kind of drug where you say "I'm feeling exceptionally crappy, so I'm going to double up on it."
posted by Mayor Curley at 2:44 AM on September 24, 2013 [1 favorite]


For those commenting on the number of deaths compared to doses taken, I hear ya but I'd point out that taking acetaminophen is the leading cause of acute liver failure. That's pretty messed up, IMHO.
posted by kat518 at 3:47 AM on September 24, 2013 [2 favorites]


So, given that Vicodin and Percocet have to have *some* acetaminophen (in the US), is there a reason they couldn't have less?

(I never found it worked for me anyways, I'm all for ibuprofen.)
posted by jeather at 5:16 AM on September 24, 2013


Acetaminophen is the HFCS of the pharma world. It's in fucking everything, for no defensively apparent reason. On its own, acetaminophen (unlike HFCS) is a useful product, but putting it in every damned thing just seems crazy.
posted by Thorzdad at 5:35 AM on September 24, 2013 [4 favorites]


HFCS is a useful product. It is sweet and it is cheap. That is its use.
posted by maryr at 7:00 AM on September 24, 2013


But like I said above, it's not always just reading the one label. It's reading multiple labels on multiple meds, which you're taking together - not even "six different pills at one time," but "I took a dose of the cough and ache syrup at 10 am, and that's got [some amount] of acetaminophen, then I took a dose of [other OTC med] that has [other amount] four hours later, then four hours after that, I took med 3 that *also* has acetaminophen" and so on. I don't remember any of the labels (and I read them because I already knew too much acetaminophen is dangerous) warning "Hey, are you taking more than one thing for this heinous cold? Check to make sure you're not over the safe recommended dose of this thing that can wreck your liver or maybe kill you, because it show up in a lot of the cold meds you're taking!" You're not always just adding up a neat little number of four Tylenol = X number of grams.

Yes, that's my problem. I'm one of those people for whom NSAIDs are a matter of trading one form of unbearable acute pain for another. I have to be very careful when I need an expectorant, cough suppressant, or antihistamine because so many OTC formulations are cocktails with acetaminophen and/or aspirin.
posted by CBrachyrhynchos at 7:01 AM on September 24, 2013


So, given that Vicodin and Percocet have to have *some* acetaminophen (in the US), is there a reason they couldn't have less?


They did, in fact, reformulate Vicodin within the past year, from 325mg to 300 mg acetaminophen. it's been a pain in the ass, to be frank.
Most pharmacies that i usually use don't have the new formulation,so I am constantly getting a call back asking if the old formulation can be substituted, which means the patient waits and waits to get the meds they need.
I am all for the reformulation (and agreed they could have dropped it more, but decided to keep a therapeutic dose), but it has been poorly executed IMO.
posted by OHenryPacey at 9:20 AM on September 24, 2013 [1 favorite]


Percocet was also reformulated in the past year or two, I believe, down to 325 mg acetaminophen.

My own feeling is that acetaminophen should be removed from most (if not all) OTC combo cough and cold medications, and come with a black-box warning with unambiguous wording on any products (OTC and Rx) that contain it.
posted by scody at 10:39 AM on September 24, 2013


One thing I'd love to see is pill bottles which displayed the last time the bottle was opened. It wouldn't necessarily tell you how many you took, but at least you'd know whether enough time had passed for another dose.

They make these! Tylenol's never going to be sold with such an expensive cap, but you can put your previously-purchased meds in there if you're having trouble remembering when you took your last dose.
posted by vytae at 12:44 PM on September 24, 2013 [3 favorites]


It boggles my mind that someone wouldn't take a few seconds to read the recommended and maximum dosage printed on the bottle. And that their failure to do this is somehow not their fault. You're taking drugs, how do you not do the basic amount of work to protect yourself?

The difference here is that for most OTC drugs, the recommended and maximum dosages are way, way below the LD50. Like, I take Benadryl almost constantly when my allergies flare up, and I once, in a spate of OD worry, calculated that I'd need to take something like 95 pills (almost 50 times the recommended dose) to even have a chance of seriously hurting myself. In contrast, especially if you're a regular drinker, Tylenol can hose your liver at doses only twice or three times the recommended dosage. You can't "lol mmkay" a Tylenol label's RD the way you can almost any other OTC label.

We treat recommended dosages a bit like we tend to treat speed limits - "Sign says 55mph? So I can almost certainly actually do 65 safely, because The Po-Po's just tryin' to keep us down" - but acetaminophen is like that one dead man's curve in your hometown where people die on it regularly because they assume the speed limit sign is as disregardable as usual and then they find themselves flying off the side of a mountain and oops, dead.
posted by badgermushroomSNAKE at 1:05 PM on September 24, 2013 [10 favorites]


I'm curious about the labelling differences between Canada and the US. This is what I have written on my bottle of EZ Tab, Extra Strength Tylenol:

In red:
FOR HEADACHE, PAIN and FEVER
Read carton for important information before use

In black underneath, samed size text
MEDICINAL INGREDIENT: Acetaminophen, 500mg per tablet
DOSAGE:Adult use only (12 years and older): Take 1 tablet every 4-6 hours. If pain or fever does not respond to 1 tablet, take 2 tablets at the next dose. Do not take more than 8 tablets per day.

Red stop sign icon: CAUTION: Keep out of the reach of children. This package contains enough medication to seriously harm a child. Do not use with other drugs containing acetametaphin. Use the smallest effective dose. Do not take more than the maximum daily dose. Overdose may result in severe or possibly fatal liver damage. Use only as directed by a doctor.
Store at 15-30 `C


Are the labels different?
posted by valoius at 3:49 PM on September 24, 2013


Thorzdad: "Acetaminophen is the HFCS of the pharma world. It's in fucking everything, for no defensively apparent reason. On its own, acetaminophen (unlike HFCS) is a useful product, but putting it in every damned thing just seems crazy."

This is a real problem. If you happen to have a combination sickness event (say allergies and muscle spasms) it's really easy to hit or exceed the acetaminophen maximum dosage because both your antihistamine and your muscle relaxant contain acetaminophen. Shoppers Drug Mart here now carries Robaxacet knock offs with your choice of aspirin, acetaminophen or ibuprofen as the included pain treatment and it's a god send vs. only acetaminophen being available.
posted by Mitheral at 4:17 PM on September 24, 2013


Do not take more than the maximum daily dose. Overdose may result in severe or possibly fatal liver damage.

I think it doesn't connect for people that "more than the maximum daily dose" is basically equivalent to "overdose" in the case of acetaminophen. Those two sentences read to the average person (if they even bother to read them) as "Follow the instructions [ignorable]. Also don't pour the whole bottle down your gullet because you could die [well, duh, of course not]."

Even a simple rewrite like "Taking more than the maximum daily dose may result in severe or possibly fatal liver damage" would be more clear, although I think it may still not be clear enough.
posted by vytae at 9:42 AM on September 25, 2013 [2 favorites]


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