FDA Asks Prescription Drug Companies To Limit Amount Of Acetaminophen

Worried about the possibility of liver damage from over use, the U.S. Food and Drug Administration has asked manufacturers of prescription drugs containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule.

Acetaminophen is a widely used pain killer and fever-reducer found in over-the-counter meds like Tylenol and Excedrin as well as a number of cough and cold remedies. It’s also combined with opioids to make prescription drugs like Vicodin, Tylenol 3 and Percocet.

When taken in high doses, and especially when combined with alcohol, acetaminophen can be hazardous to a user’s liver.

There has been a growing concern in recent years about the number of medications containing acetaminophen, sometimes called APAP. While a patient taking Vicodin may be aware that they shouldn’t also be popping a Tylenol, they may not know that their cough medicine also contains acetaminophen.

The FDA says an adult should take no more than 4,000 mg of acetaminophen in a 24-hour period.

In addition to asking manufacturers to limit the per-pill amount of acetaminophen in prescription drugs, FDA is requiring them to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury.

“FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER). “Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death.”

According to the agency, this elimination of higher-dose acetaminophen products will be phased in over three years and “should not create a shortage of pain medication.”

As for patients currently taking meds containing more than the 325 mg per tablet of acetaminophen, the FDA says:

There is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their health care provider… The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period.

The FDA has set up several pages with information about affected products and acetaminophen in general. Click here for more information.

Comments

Edit Your Comment

  1. pecan 3.14159265 says:

    Step 1: Read the medicine label
    Step 2: Avoid mixing medications
    Step 3: Avoid overdosing on any particular medication by researching beforehand the active ingredients and types of medications you are taking
    Step 4: Seriously, you need any more direction?

    You’re telling me that who mix medications, drink alcohol with their meds, and thus, are generally irresponsible with their own health should be saved from themselves…how about the fact that they’ll just take more pills?

    • Veeber says:

      But part of the problem is that people don’t know that there is acetaminophen in some of those drugs. Especially the prescription ones since the label rarely discusses the individual components, just the generic name of the combination.

    • aloria says:

      Judgmental much?

      The problem is the therapeutic dose for acetaminophen and the dose at which is starts to hurt you aren’t that far apart. That’s okay on its own, but when you start taking it with other drugs that is also hard on your liver, the combined toll can be too much. Medicine labels don’t take this into account and doctors rarely go down the gamut of ORC drugs you *might* take.

      Example: I used to take Lithium, which is a medicine which is also very hard on the liver. The literature that came with my medicine didn’t say anything about not taking acetaminophen– it said to avoid ibuprofen and naproxen, but nothing about acetaminophen. I mentioned in passing to my doctor that I took some Tylenol for a pulled muscle and he flipped out. How was I supposed to know? He didn’t tell me, and nothing that came with either set of medications warned it would be a problem. Is that irresponsible in your eyes?

      • aloria says:

        *OTC

      • Tyanna says:

        Irresponsible of your doctor, yes.

        • aloria says:

          That’s exactly the problem, though– doctors all too often rely on the pharmacy to catch any interactions between medicines, especially nowadays when people have one doctor for their back problems, another for dermatology, one for psychiatry, etc. However, pharmacy systems are not fail proof.

          Take another example– accutane is another drug that is very hard on the liver. Let’s say I am taking it under the care of my dermatologist, and then pull my back and have percocet prescribed for pain management. Drug interaction checks don’t pick it up:

          http://www.drugs.com/drug-interactions/accutane-with-percocet-72-1135-1403-828.html

          But using both over a period of time (normal accutane courses are 6 months) could hurt one’s liver.

      • pecan 3.14159265 says:

        Let me explain. These two sentences popped out at me:

        While a patient taking Vicodin may be aware that they shouldn’t also be popping a Tylenol, they may not know that their cough medicine also contains acetaminophen.

        Right, so a patient taking prescription medication should be aware that they shouldn’t be mixing medications, but may not know that a cough medicine also contains acetaminophen? Since very rarely do people have prescription cough medications, and all OTC meds disclose active ingredients, I took this sentence to mean that people who take prescription pills are fully aware of the amount of acetaminophen in their prescription drugs.

        FDA is requiring them to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury.

        Also, the FDA wants drug companies to also modify their labels to reflect a warning for potential liver trouble in case of overdose or mixing drugs. I was totally under the impression that drug companies already disclose the active ingredients in their drugs, and that the FDA was asking for a change in the label to reflect a warning, not to disclose the active ingredients.

        I mean, if the NIH says you can take 4,000 mg a day, and your prescription drug information and OTC drug information both disclose active ingredient dosages, wouldn’t you know how much medication you’re taking? Unless we’re taking into account additional ingredients (not acetaminophen) that also contribute to liver problems.

        • aloria says:

          Well obviously someone who is taking more acetaminophen then they should when they know the upper daily limit isn’t going to be helped. However, I don’t see the problem with warning of potential liver damage on drugs of these nature, acetaminophen or not. If I saw “hey, this might screw up your liver” on both my bottle of lithium and tylenol, or my package of accutane and percocet, I’d be more likely to call my doctor or pharmacist up and ask “um, did you guys make a mistake? should I really be taking both of these?”

          Let’s face it, doctors screw up sometimes– giving patients tools to identify mistakes is a good thing. Not everyone thinks to go on wikipedia to look up whether a medicine is hepatically or renally metabolized.

    • spanky says:

      Also keep in mind that people aren’t always on top of things when they’re sick or in pain. If you’re laid up with something, or in excruciating pain, you’re more likely to do things like lose track of time (and OD by taking painkillers too close together), or to just plain not think to check your medicine labels.

      And in this case, as aloria points out, the levels at which Tylenol can cause serious harm are not far off from the normal prescribed doses, so you don’t have much margin for error.

      • jesirose says:

        So make the painkillers less effective so you’re in even more pain and can’t think clearly at all?

        • spanky says:

          There is always a balance you have to strike between safety and efficacy.

          All you really need to know is that accidental Tylenol overdoses can be very dangerous, and they’re extraordinarily common. It’s clear that the balance needs to tip a little more to the ‘safety’ side.

    • ParingKnife ("That's a kniwfe.") says:

      Spoken like someone who doesn’t have to take a gajillion-and-a-half pills just to function every morning.

      My fiance’s father has been taking pills for multiple ailments including a heart-valve replacement for more than a decade now and even though he’s an intelligent person with multiple PhDs, the doctors put him on and off so many drugs so frequently, it’s hard to keep up. It’s also not hard for the docs to make mistakes and he’s had to change out doctors a few times for that reason too.

      • Griking says:

        Yeah but I think the point is that instead of your taking a 500mg pill every day most people will now probably take 2 325mg pills instead completely defeating the point of the change.

        • ParingKnife ("That's a kniwfe.") says:

          The point of the change isn’t to stop people taking a higher dose. It’s to keep people from overdoing it when taking as directed. Now you end up taking less than a gram as a maximum dose.

          • MauriceCallidice says:

            Yup, the point was to make existing medications have less of one of the active ingredients, and consequently potentially less effective. Yay?

            • ParingKnife ("That's a kniwfe.") says:

              Yay.

              How effective is a drug at certain dosage? I don’t know, let’s ask the people who determine these things. Oops, looks like it’s actually the FDA.

            • Chaosium says:

              “Yup, the point was to make existing medications have less of one of the active ingredients, and consequently potentially less effective. Yay?”

              Don’t be stupid. Acetaminophen does not need to be in prescription medication.

            • Firethorn says:

              Sure, it can potentially be less effective with less acetaminophen – but is it, really? I understand that Tylenol w/codeine is mostly effective because of the codeine.

              Medicine is a balancing act, especially when the risk of permanent damage is there for drugs.

              This change is probably the result of a long term study.

    • fortymegafonzies says:

      I think part of the problem here is that people just assume that OTCs are safe when, in this case, they are not entirely so. So what you get is some busy, absent-minded parent giving his child cough medicine and then something else for fever, maybe misreading the dosing cup, kid spits it out and he’s not sure much the kid actually swallowed so he gives him more etc., and what you wind up with is irreversible and fatal liver damage in some little kid. It is perfectly rational to reduce the amount of APAP in many OTCs, especially combination products, to reduce stupid accidental OD scenarios. Keep in mind that APAP overdose is the #1 cause of liver failure in this country, and it doesn’t seem like too much of a burden for you to have to buy an extra bottle of APAP for $2 if you really want to take alot of it.

      • jesirose says:

        So because some parents are absent minded and don’t pay attention when giving their kids drugs, everyone else should get less medicine?
        I can’t imagine NOT reading every line of the label giving my own kids medicine, when my baby brother had to have medicine you bet everyone in the house knew exactly how to handle it. Bad parenting is on the parent, not the rest of us or the medicine manufacturers.

        • fortymegafonzies says:

          I agree with you, but that doesn’t change the fact that: APAP doesn’t need to be in all medications, a kid doesn’t deserve to die just because his parents are stupid.

  2. Nigerian prince looking for business partner says:

    I was always under the impression that Tylenol was intentionally put in narcotic painkillers to deter people from abusing them. I didn’t realize there was a therapeutic reason for adding it in, when it could be so easily prescribed in addition to the opiate.

    • Alvis says:

      THIS.

      I know people today are all about convenience above all else, but wouldn’t it be a much better idea to have all medications be single-active-ingredient?

      Instead of having 84 different kinds of cough medicine, all just different balances of a few main ingredients, they could sell the DXM, guaf, diphenhydramine, and paracetamol, seperately. Mix and match based on your symptoms, as needed.

      • Reading_Comprehension says:

        There might be some backlash from selling straight DXM…..not from me though

      • Veeber says:

        But you can patent the combinations :)

        • partofme says:

          This is exactly it. The money is in combinations.

        • Alvis says:

          I don’t think that’s right – just checked a bottle of migraine pills containing a mix of OTC ingredients and there’s no patent notice.

          • ParingKnife ("That's a kniwfe.") says:

            That’s probably because that particular mix had its patent expire. Ask any doctor, when the patent on a heart medication expires, the manufacturer’ll tack on an antacid, or offer a rapid release version. This is why you’ll see a drug like Panacea(TM) suddenly start marketing itself as PanaceaEX(TM) where the EX references the combined or added function.

    • dangermike says:

      That is, as far as I understand it, true. Another reason for doping opiates with acetominophen is to help the pain killer by adding an anti-inflammatory to the mix. But acetominophen can be tough on the liver and in some cases, if a large dose of real pain killer is needed and/or liver function might be a concern (particularly true for patients who are cholesterol controlling medications), there are often lower acetominophen versions (such as lorcet for vicodin)

    • Mom says:

      Acetaminophen is put into the pill with an opiate because it works synergistically with the opiate, to give more pain relief than what you’d get with just the opiate alone, or just the acetaminophen alone.

      You’re probably thinking of guifenesin, which is put into cough syrups. Besides the medicinal qualities (loosening phlegm), it will make people puke before they ingest enough to overdose.

  3. Emperor Norton I says:

    So if this goes through, I will just take 3 – 325 mg caplets, instead of 2 – 500 mg caplets.
    Thoroughly idiotic!
    The correct thing to do is to ban combining acetaminophen with any other drug, so no one takes a combo drug & two acetaminophen tabs with it!

    If there’s a wrong way to do it, the FDA will use that way!

    • nova3930 says:

      Or how about just assume people are going to read the #$(%*&$%( label and if they don’t be satisfied that a little chlorine was added to the gene pool…

      • AwesomeJerkface says:

        It’s a shame that acetaminophen isn’t always labeled as an ingredient in combo-drugs because it’s perceived to be innocuous… oh wait… that’s one of the parts of this law they want to pass.

        Maybe you should read the #$(%*&$% article?

      • ParingKnife ("That's a kniwfe.") says:

        Hooray for social Darwinism and eugenics!

    • pecan 3.14159265 says:

      Also, because you’ll take three pills instead of two, you’ll run out of pills faster and will have to purchase another bottle sooner. I imagine drug companies actually make more money this way.

      There’s also really no way to ban people from mixing medications if they’re just ignorant and haven’t bothered to read the labels. Many over the counter drugs medications have acetaminophen. Even if the FDA could flag two acetaminophen products purchased together, nothing would happen if I went to the counter with just one acetaminophen product and happen to have at home Tylenol I bought a year ago.

    • sqlrob says:

      2*500 = 1000
      3*325 = 975

      You’re taking less. So it’s not as idiotic as you think.

  4. Mike says:

    I can buy codeine over the counter in Canada, but we can’t handle Tylenol in this country? In all seriousness, what is wrong with the US?

  5. bethshanin says:

    screws up my meth-lab formulas

  6. JohnJ says:

    I don’t use Tylenol, because for me, it doesn’t work. My understanding is that it is not an anti-inflammatory, which would explain the lack of effectiveness.

    • ParingKnife ("That's a kniwfe.") says:

      It is an anti-inflammatory, it’s a COX-2 inhibitor. I think you mean it’s not a conventional NSAID. The reason it probably doesn’t work for you is that it seems to be highly selective in terms of COX inhibition, targeting mostly COX-2. This means it doesn’t reduce inflammation in many tissues where COX-2 is not part of the dominant mechanism. All this is just FYI, I learned all of this when I was studying molecular biology and biochem, and I never get to use that knowledge anymore.

  7. danic512 says:

    Oh god the FDA is asking nicely if smaller pills could be made so that the active ingredient could be more precisely administered! The HORROR!!

  8. Zydia says:

    so I have to pay more for Midol now?

  9. EverCynicalTHX says:

    They damn well should limit the Acetaminophen in most cold medicines. It’s not needed in most cases and if individuals want it they can easily buy supplemental Acetaminophen to add at their own discretion for virtually nothing as a generic.

  10. fortymegafonzies says:

    Note that acetaminophen doesn’t actually have to be combined with alcohol to increase the risk of liver damage. If you drink a few drinks on a regular basis, you should probably avoid acetaminophen even when you’re not drinking — this is due to a metabolic effect that alcohol has that lasts much longer than the booze itself stays in your system.

  11. yagisencho says:

    I encountered this problem last week while fighting a migraine. I was taking DayQuil (contains APAP) at the time for a cold, so didn’t want to risk popping an Excederine Migraine at the same time. (EM works wonders for me, but you’re not supposed to take more than two pills in 24 hours, and no mixing!) My migraine was slipping out of control, so I sucked down some Children’s Motrin instead and waited it out.

    I’m grateful for pain medication, but does it have to be so toxic?

  12. keepher says:

    The solution is a heck of lot simpler than having them remove the acetaminophen from the RX drugs, take it out of all of the OTC stuff. It drives me crazy when I go to buy something and I find that most everything has a pain reliever added that I do not want.

    Truthfully, how many people are taking controlled substance pain relievers on a regular basis? Not many and those people are probably very aware of what they are taking and what they can and can not take with it.

  13. Rose says:

    …no more than 325 mg in each tablet or capsule.

    Right, so instead of taking one 500 mg pill, they take two 325 mg pills. Great idea, FDA.

  14. golddog says:

    This is a good move. It could go further though. APAP is in freakin’ everything and can be hepatoxic far below 4000mg w/other factors like alcohol, cigarette smoking, high protein diets, being on antibiotics or other drugs processed through the liver (almost all of them). I’ve personally tried to make the switch to ibuprofen for pain/cold stuff, which is way easier on the liver and still allows a frosty alcoholic beverage.

    • Press1forDialTone says:

      But ibuprofen can make your digestive system bleed
      if its not 100% healthy and thins your blood a bit as
      part of its anti-inflammatory effect.

      There is no perfect solution although
      I like the one where you take out all APAP
      in combo with anything. It’s nearly worthless
      as a product anyway and is hard on the liver
      period.

  15. Papa Bear says:

    This is a good move if only a partial one. I’m with those who feel APAP should be taken out of all meds except prescription meds in which it is specified as part of the med. Goes for ibuprofen, also. Because of scripts, I can’t use OTC’s with APAP. There are times it is a pain to find a cold med w/out it. Since ibuprofen, although an NASAID, causes swelling in my feet and ankles, I can’t use that either and often, that is the alternative to w/APAP.