FDA: Limits on Acetaminophen

Acetaminophen dose recommendations will be lowered significantly by the FDA, and some products will be pulled off the market, because of concerns over liver damage. If you look up “Tylenol” on Wikipedia as I write this, you see the following:

i-840772567044866599ba31c8157a592a-ThisWikiHasProblemTylenol.jpg

Indeed.

From MSNBC:

Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., according to the FDA.

Panelists cited FDA data indicating 60 percent of acetaminophen-related deaths are related to prescription products. Acetaminophen is also found in popular over-the-counter medications like Tylenol and Excedrin.

“We’re here because there are inadvertent overdoses with this drug that are fatal and this is the one opportunity we have to do something that will have a big impact,” said Dr. Judith Kramer of Duke University Medical Center.

Comments

  1. #1 Jason Thibeault
    June 30, 2009

    Well. To that, all I can say is…

    You’re still using the Human theme???

  2. #2 Whitecoat Tales
    June 30, 2009

    I’m not sure how much it will help.

    I mean, anecdotally, I’ve seen a few cases of acetaminophen overdoses. The inadvertant ones (read:nonsuicide attempts) were associated with alcohol or other substance use, and the patients didn’t know/didn’t care that the product contained acetaminophen.

  3. #3 John Swindle
    June 30, 2009

    “years of educational campaigns and other federal actions …”? I don’t recall ever hearing about Tylenol killing anyone. I’m pretty sure that would’ve gotten my attention. So either I’m more dense than I’d like to think, or the educational campaigns and other federal actions have been ineffective. Okay, maybe both.

  4. #4 Dan J
    June 30, 2009

    Didn’t know about the relationship between acetaminophen and liver damage? I thought everybody had heard of that. Then again, that may be one of the factors in the inadvertent overdoses.

    There’s also the problem with a lot of OTC cold and flu remedies containing acetaminophen. People who don’t read the label are likely to take still more of the stuff for their aches/pains/fever on top of what they get in other medication.

    Greg still uses “Human”?!?!? I change mine around whenever I get the whim to do so. Right now it’s a “Dust” variant.

  5. #5 Jason Thibeault
    June 30, 2009

    Wikipedia appears to have been having a legitimate database hiccup. It seems to be back up now. I don’t know if any information has been whitewashed in the meantime, but I can’t imagine what if anything would need to be removed by the men in black.

    [edit] Dangers
    Main article: Paracetamol toxicity

    Acetaminophen causes three times as many cases of liver failure as all other drugs combined,[7] and is the most common cause of acute liver failure in the United States,[6][8] accounting for 39% of cases. While it occurs through overdosing[5], even recommended doses especially combined with even small amounts of alcohol, have caused irreversible liver failure. [9][10] The other over-the-counter painkillers, ibuprofen and aspirin, do not cause such problems.

  6. #6 Me
    June 30, 2009

    Of course, ibuprofen and aspirin cause those pesky bleeding problems.
    No free lunch…

  7. #7 Greg Laden
    June 30, 2009

    What? You mean you can change the way this desktop environment looks and customize it and stuff? Cool!

    Actually, Human rocks for all the window decoration, etc. I don’t use wallpaper, never have. Just black, like god intended unused parts of the monitor to look (or green or blue, depending on the monitor).

  8. #8 ashok
    June 30, 2009

    People should take responsibility of their health.
    One reason for spiralling healthcare cost is prescription drugs in this country. FDA should worry about controlling the quality of drugs than sale of drugs.

    Looks like FDA is ensuring good cash flow to doctors and Drug retailers.

    For eg.

    I use Rx drug Seroflo (India ) 125 mg ( equivalent of Advair (US)) for 60 days. It costs me 15$ in India but advair ( 1 month prescription ) costs me copay of 20$ ( assuming total cost could be more than 100$ ).

  9. #9 Greg Laden
    June 30, 2009

    ashok: Mainly, the FDA is doing this: Requiring that labeling be changed so that the total amount of this drug that a person ingests while following the instructions exactly (but maxing it out) is not fatal (in a small number of instances) and to some extent addressing this issue of accidental overdose being caused by multiple sources (as mentioned above). Interestingly, the drug companies are complaining that the recommendations go too far. A (small) number of individuals have died taking the amount allowed by the label. Those individuals are obviously on one end of a distribution. So, if you want to optimize sales, you figure out legal costs per death, and profits by increasing recommended maxima, and I think a simple linear programming model will give you the number of people that you can let die and still turn a profit.

    Or, you can lower the maximum a bit and have those innocent customers not die.

    Drug companies have to take responsibility for their own actions.

  10. #10 Dan J
    June 30, 2009

    Drug companies have to take responsibility for their own actions.

    That’s yet another problem with some of the drug companies. It’s their opinion that if the FDA approved a particular medication, that absolves the company of any liability if something happens to go wrong because of it. They like the FDA when it’s to their advantage.

  11. #11 Greg Laden
    June 30, 2009

    I wouldn’t mind a system where the FDA called the shots and took the hits if consumers/patients were really well protected tort-wise. I know that is heresy, but considering that people are almost universally stupid and untrustworthy …

    (Maybe I’m just in a bad mood.)

  12. #12 Donna B.
    July 1, 2009

    What I don’t understand is why the FDA is not taking a stronger stance on OTC drug containing acetaminophen. My father takes hydrocodone for his severe arthritic pain. That he gets by prescription. What I’ve had to explain to him is that the sinus drug he takes OTC also contains acetaminophen and he must be careful not to take too much.

    If he were to be a statistical point, would it be attributed to his prescription drug or the OTC drug? It’s obvious that it’s the combination thats the the culprit.

  13. #13 Arkady
    July 1, 2009

    Do they already have packet size limits on acetaminophen in the US? In the uk OTC paracetamol (the generic name for the drug over here) can only be sold in packets of 16 (500mg tablets), with a limit of 2 packets per customer. Apparently it’s reduced the number of ‘spur-of-the-moment’ suicide attempts involving paracetamol considerably, tho I don’t have the data to hand. (it’s also thought to make a difference on suicide because the person has to push all the pills out of the packaging instead of downing a bottle, even if they do OD it’s likely to be at a much lower and hopefully not fatal level)

  14. #14 Samantha Vimes
    July 1, 2009

    Honestly, I am so much better informed about health matters than the average layman I impress doctors and have to clarify to in-laws and friends that I don’t have a degree. I use the right terms for bones (patella, clavicle, etc). I treated my own broken arm (admittedly, thinking it was soft tissue for the first 3 months), but did so well the bone was already as set as if I’d had a cast and doctor’s care for a year! So I pretty well know typical OTC medicines and side-effects, but the articles I read on Tylenol in the past made it sound like the main concern was long-term effects. I really did not know acute poisoning was that easy, especially considering how low a toxicity rating it has in Deadly Doses (a Writer’s Guide to Poisons).

    In short (too late!) YES there needs to be a clearer warning on it. I just feel happy that Tylenol does *not* work for pain relief on me, so I always go with Advil or aspirin for a single use medicine. And if I have to have something with acetaminophen in it because that’s how it is made, then I grit my teeth and do without the pain relief, because I did know that mixing pain relievers ups the chances of liver damage.

  15. #15 ben
    July 1, 2009

    I think more people need to take a bigger picture approach to this latest FDA news. Who is the FDA ultimately protecting? How long do they wait, how many lives are affected before they take this kind of action on big pharma drugs? Too long. How long do they wait to come down hard on the natural health industry when a few people lose their sense of smell (for example)? Not that long. The makers of Zicam got dragged through the media a few weeks ago after 100 or so people lost their sense of smell temporarily over a ten year period, but it takes 20 years or so for the FDA to say anything about the drug that is the leading cause of liver failure in the U.S. What’s the problem here? The FDA Investigates Acetaminophen Safety – Swanson Vitamins Blog

  16. #16 Kelly
    July 1, 2009

    They are not just reccomending a black box warning, they are talking about banning prescriptions that have tylenol in the mix. The problem is that a lot of these drugs do not have a replacement without the mix.

  17. #17 Stephanie Z
    July 1, 2009

    ben, that’s utter bullshit. The FDA has not been ignoring acetaminophen in the least. As the news report says, this is just the latest step in a very long campaign to make acetaminophen use safer.

  18. #18 catgirl
    July 1, 2009

    Unfortunately, some people just ignore dosing instructions and warnings on OTC. I once gave a coworker a painkiller with Naproxen in it. The recommended dose is 1-2 caplets, and he decided to take 3 for no reason at all. I don’t know why he ignored the instructions or why he thought he knew better than everyone else. I think black box warnings and education will help a lot of people, but I don’t know what to do about the others like my coworker.

  19. #19 Jason Thibeault
    July 1, 2009

    I think you’re seriously understating the harm of putting zinc up your nose, Ben. It’s not that some people temporarily lost smell. It’s that a lot of people temporarily lost smell and some people PERMANENTLY lost smell, and it wasn’t scrutinized because the damn thing was labelled as “homeopathic” and got around laws that would have said, “no, you can’t have zinc in a nasal gel”.

  20. #20 Ben
    July 1, 2009

    Stephanie Z:
    “Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., according to the FDA.”

    Apparently your “very long campaign” hasn’t been very effective. You can say you’re protecting the public and lead “very long campaigns” to promote safety, but if remains the leading cause of liver failure, there’s still a problem. More could have been done.

    Yes, you’re right. Many people did lose their sense of smell permanently. But I would rather be protected against liver failure and possible death than losing my sense of smell. That’s just me. I also never said the FDA was ignoring anything.

  21. #21 Stephanie Z
    July 1, 2009

    it takes 20 years or so for the FDA to say anything about the drug that is the leading cause of liver failure in the U.S.

    Ben, time to pay attention to what you’re saying.

    You’re also ignoring the fact that there should be different approaches to handling acetaminophen, which does something for most of the people who take it, and homeopathic remedies, which don’t. There are very good reasons to try an educational approach in dealing with nonrecommended dosage and drug interactions in a drug that provides pain relief for a huge number of people who can’t take other OTC analgesics. The problem is not the drug. The problem is not reading labels.

    In the case of Zicam, the problem is the drug. To top that off, it’s a drug that doesn’t do anything–except when it has this lovely side effect. The tiny bit of inconclusive evidence that suggests zinc might shorten a cold by a day or so applies to oral ingestion, not nasal gels.

    However, there’s enough evidence that topical zinc on the mucus membranes can cause anomia that the manufacturers were nothing but negligent in including that in their product. If they had to meet the same standards of efficacy and safety that real drugs have to meet, the gel would never have been on the market, and no one would have lost their sense of smell over it.

  22. #22 Ben
    July 1, 2009

    Jason, I assure you that it is nearly impossible for a natural health company to “get around laws,” unless you’re planning on not being around very long. There are companies like that, and it is they who are continually giving our industry a black eye. But the FDA does their part and cracks down on those types of people/companies. Compliance is a huge issue and we take it incredibly seriously.

  23. #23 Ben
    July 1, 2009

    Stephanie, ignoring and purposely staying silent are two completely different things. Again, I never said “ignore,” I choose my words carefully.

    If the problem is not reading the labels, then that discounts your previous argument claiming so much has been done with “very long campaigns” that have educated the masses. Why is nobody reading the labels then?

    If you want to talk about evidence, then consider the massive amount of evidence pointing to the dangers of your artificial pain-killer. You can’t use evidence to charge down one path but ignore evidence to avoid the other path.

    I am not defending Zicam or the makers. My whole focus was on the priorities of the FDA.

  24. #24 Barry
    July 1, 2009

    While most educated folk know that acetaminophen causes liver failure, the majority of the public does not. When I first read about the acetaminophen crack-down, my first thoughts were “What’s the point!?”. The doctor that I just spoke with agrees. I don’t know the numbers, but it would be interesting to see… how many of that 40,000 is suicide related ingestion of acetaminophen. Note that you are not going to stop people from commiting suicide by limiting the dose of their drug-of-choice, they are just going to take more pills to get the job done. Could tylenol and other acetaminophen drugs contain stronger warnings? Yes. Should they? Probably. Is this a major major health concern? No.

  25. #25 Barry
    July 1, 2009

    Ben. Just stop. You’re a moron. You’ve clearly demonstrated that you know nothing about pharmacology, medicine, and logic-thinking.

    Tylenol: Has a use. It’s used ALL the time because it is useful. It is both dangerous and useful.

    Zinc: Only dangerous. Not useful. See the difference?

    And please don’t comeback with some half-ass argument about Zinc being an essential micronutrient. I understand that it is necessary for normal physiology, but as for colds, it’s useless.

    Remember the old saying…

    “IF ALTERNATIVE MEDICINE WORKED, IT WOULD NO LONGER BE CALLED ALTERNATIVE MEDICINE, IT WOULD BE CALLED MEDICINE.”

  26. #26 Stephanie Z
    July 1, 2009

    Ben, it is purposely ignoring when Swanson’s Vitamins still sells Zicam nasal products?

  27. #27 Ben
    July 1, 2009

    Stephanie, yes we indeed still sell the Zicam products that were not included in the FDA’s warning. No issue there.

  28. #28 Ben
    July 1, 2009

    I think the name-calling is unnecessary, but I do appreciate the debate! There may be a misconception out there that the natural health industry is not regulated and nobody’s watching out for you. In fact, we are an extremely regulated industry by both the FDA and the FTC. We work very closely with both agencies to maintain compliance to the rules and regulations they issue…rules set in place for the safety of the public. Here’s a full explanation of how we are regulated: http://bit.ly/fD1eh

  29. #29 Anthony
    July 1, 2009

    “Ben. Just stop. You’re a moron.”

    Quote: Barry, the classic internet tough guy.

    There are many Alternative approaches to health that can do incredible things.

    Have fun taking prescription drugs for your symptoms and then dealing with their side effects. Conventional ‘Medicine’ as you call it, is really great today, isn’t it.

  30. #30 xavier
    July 1, 2009

    One person’s side effects are another person’s effects. As in estate.

    Michale Jackson for instance.

  31. #31 Stephanie Z
    July 1, 2009

    My answer got long, Ben.

  32. #32 Barry
    July 1, 2009

    Anthony, you called me an internet tough guy!!… but… you didn’t address anything else. Let’s just take it from the top.

    “There are many Alternative approaches to health that can do incredible things.”
    First off, why are you capitalizing Alternative? Is that supposed to portray a false sense of authority? Like christians capitalizing “Him”?
    Secondly, no they can’t (which is probably why you didn’t cite any examples). Again, if they did amazing things, they would no longer be called “alternative”, they would just be called pharmaceuticals.

    Just like Ben… you proceed to demonstrate an unchained ignorance toward the concept of pharmacology. It is in the first chapter of any pharmacology book. All drugs have effects. Period. SOME of these substances have beneficial effects, but EVERY substance known to man can be toxic at the right dosage. Think about it. Now read your quote.

    “Have fun taking prescription drugs for your symptoms and then dealing with their side effects. Conventional ‘Medicine’ as you call it, is really great today, isn’t it.”

    You actually get the first part right!! Every drug on the market today has side effects! Great job for revealing the truth! But then it falls apart… Did you really just try to suggest that alternative medicines are better than Big Pharma Drugs because they don’t have ANY side effects? Every drug has side effects, regardless of its classification as conventional or alternative. The difference between the two groups is that conventional medicine has been shown to WORK. Alternative medicines are only “believed” to work. Doctors who care about their patients, friends, and family are patiently awaiting the results of any studies that validate your claims. NOBODY wants to see a drug fail. It would be AWESOME if every herb and mineral were shown to have beneficial effects with no side-effects! Unfortunately, the exact opposite has been shown time and time again. The vast majority of alternative drugs, those of which have been tested, have been shown to have no more effect than placebo, in addition to the side effects they cause. Perhaps go to the library and find a pharmacology textbook. Take a look at the “Alternative Medicine” chapter (most modern textbooks include one).

    I could be wrong though. Perhaps it’s a giant world-wide conspiracy between millions of scientists and doctors?

  33. #33 Anthony
    July 2, 2009

    Barry –

    You are right that natural products have side effects and can be toxic at a certain level. The thing is, usually that level is ridiculously high compared to the average prescription drug.

    As for the prescription drugs: The big problem is that they are only prescribed to treat your ‘symptoms’. ‘Oh, your feeling sad – you must have a prozac deficiency. Take this for the next 30 years’ — Great system we have here.

    People need to find the root cause of their illness and treat it naturally.

    If you are completely happy with modern medicine — good for you.
    I was not happy with it, and have chosen to use a safer, natural approach.

    As for evidence? Search PubMed – you can find a lot of good studies on natural products. Are there as many studies as there are on drugs? No – because you can’t patent a natural product and make a gigantic profit (which pays for the studies).

  34. #34 Stephanie Z
    July 2, 2009

    Anthony, nutriceuticals are a multi-billion dollar business. Such big business, in fact, that Ben’s coworkers decided to invade the comments of my blog this morning. If you’re one of them, you might want to know that Greg is capable of documenting astroturfing just as well as I am.

  35. #35 Barry
    July 2, 2009

    Anthony, I truly don’t know why I bother replying. At least you appear to have read what I wrote. I’ll even say that you get a few things correct!

    RIGHT:
    “You are right that natural products have side effects and can be toxic at a certain level.”

    WRONG:
    “The thing is, usually that level is ridiculously high compared to the average prescription drug.”

    Again, to understand why that sentence is such a tradgedy… you’re going to need to read the first few chapters of a pharmacology book. Seriously… it’ll take you an hour at most. We compare the efficacy and danger of drugs based on things called “effective dose” and “lethal dose” among other terms. The ED50 is the effective dose that works for 50 percent of the subjects (usually rats). The LD50 is the lethal dose for 50 percent of the subjects. The safety of a drug is measured by a ratio (something like LD50/ED50 or LD1/ED99 something like that I don’t have the time to look it up). Note that most alternative medicines don’t have an “effective dose” because they don’t have a measurable endpoint! However, all alternative medicines have a lethal dose, no bones about it. Do you understand why your quote above makes absolutely no sense? To suggest that conventional medicines have a lower safety margin than alternative medicines is absurd. You’re comparing drugs that work, to drugs that don’t. Not even apples and oranges.

    WRONG: “As for the prescription drugs: The big problem is that they are only prescribed to treat your ‘symptoms’. ‘Oh, your feeling sad – you must have a prozac deficiency. Take this for the next 30 years’ — Great system we have here.”

    You’ve gone off the deep end here. I’m honestly contemplating if you’re a Poe.

    WRONG: “People need to find the root cause of their illness and treat it naturally.
    If you are completely happy with modern medicine — good for you.
    I was not happy with it, and have chosen to use a safer, natural approach.”

    What do you even mean by “root cause of their illness”? Do you mean spirits? Do you mean molecules? What on earth are you talking about? And what is your obsession with the word “natural”? You, sir, have fallen for the naturalist fallacy! For some reason, you and many other people think that because something is natural, it’s good, and that if something is synthetic, it’s bad. Many of the drugs we use today are natural (we just don’t call them alternative or “natural” medicine because it’s pointless). Botulism toxin is natural. So are bacteria. Leukemia is natural. The statins are NOT NATURAL. Many antibiotics are synthetically altered. The computer you’re reading this on is NOT NATURAL. Again, you’ve fallen for the naturalist fallacy. Classic. Your brain needs rewiring bro.

    Hey you get one right!
    CORRECT: “As for evidence? Search PubMed – you can find a lot of good studies on natural products. Are there as many studies as there are on drugs? No – because you can’t patent a natural product and make a gigantic profit (which pays for the studies).”

    Yep, that is an unfortunate part of our system today. Many drugs don’t get studied due to lack of funding, probably because a lack of profitability. That being said… and I’ve repeated this several times now. IF AN “ALTERNATIVE” or “NATURAL” drug has been shown to work on PubMed… it is no longer considered an alternative medicine, or a “natural” medicine… from then on, it is just medicine. Doctors use drugs that have been shown to work. We don’t care whether it’s natural, herbal, synthetic, alien, whatever you want to call it. We use drugs that are safe enough to where the benefits outweigh the risks. Note that if a drug has no benefits (ie alternative meds), the benefits will never outweigh the risks.

  36. #36 davidp
    July 2, 2009

    Why aren’t the FDA suggesting requiring methionine to be included in medicines with Acetaminophen? Methionine counteracts the glutathione depletion in the liver, which is apparently the main mechanism of liver damage due to Acetaminophen overdose.

    I’d have thought this would be more effective than changing the labelling on boxes, and expecting that to change people’s behaviours, which seems to be main reaction the Australian drug regulator is proposing.
    [I do not have any involvement in sale or manufacture of drugs]

  37. #37 Ellistrae
    July 10, 2009

    This whole thing concerns me. As a patient with chronic pain issues, I take Percocet on a daily basis to manage my pain. I am well aware of the possibility of liver toxicity, so I am very careful not to take too much and check labels on anything else that I might consider taking. But if the FDA bans the combination medications, which would include things like Vicodin and Percocet, where does that leave those of us with a legitimate need for pain control? Are we just supposed to use pure narcotics? Or are we going to get totally screwed? Believe me, I wish I could live a normal life without pain medication of any sort, and I am actively trying to find a solution to my very bizarre health problem, but I cannot function without pain relief, and aspirin is not going to cut it. I seriously hope the FDA does not leave those of us with chronic pain out in the cold on this one. I dare any of them to walk a day in my shoes and then tell me that I don’t need anything stronger than aspirin or some other OTC medication.

  38. #38 Stephanie Z
    July 10, 2009

    Ellistrae, my understanding is that the FDA has decided to make no change in the prescription drugs, just change the warning labels.

  39. #39 Kate
    July 21, 2009

    check out our website Needs to be updated because of a gag order but may answer some questions.
    http://www.drug-warning.org

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