Take Three; They're Smaller Now


Yesterday an FDA advisory panel recommended that Vicodin, Percocet, and other painkillers combining opioids with acetaminophen be taken off the market. Most of the 400 deaths and 42,000 hospitalizations related to acetaminophen overdoses each year involve such combination products. The risk is of special concern to people who take prescription medications like Vicodin (hydrocodone plus acetaminophen) and Percocet (oxycodone plus acetaminophen) for chronic pain. Contrary to popular perceptions, it's the over-the-counter ingredient in such prescription painkillers, as opposed to the narcotics, that poses the main health danger for people taking them over extended periods of time. Such patients develop tolerance to the opiods and have to raise their doses, which can be done safely and indefinitely, except that it also increases the danger of liver damage from the acetaminophen. Doctors who reflexively prescribe opioid-and-acetominophen combinations probably should be more cautious and consider alternative formulations, especially when their patients may be taking these drugs for a long time, and patients should be more aware of the acetaminophen risk. But that does not mean such drugs are never appropriate for anyone in any situation, so a ban seems hard to justify even on paternalistic grounds.

A second recommendation from the advisory panel is based on even shakier reasoning. It said the maximum dose for over-the-counter acetaminophen products such as Tylenol should be reduced from 500 milligrams to 325 milligrams per pill. This proposal does not seem to be based on new data indicating that the current recommended dose is unsafe:

Linda A. Suydam, president of the Consumer Healthcare Products Association, said the committee had ignored studies showing that doses sold by her members—two pills of 500 milligrams, up to four times a day—were safe. "I think this is a very effective dose and one needed for individuals who experience chronic pain," she said.

Instead of adjusting what's considered safe and effective based on new evidence, the dose reduction seems to be aimed at lowering the risk to people who exceed the current guidelines. The change therefore would sacrifice the interests of consumers who follow instructions for the sake of consumers who don't. And if people find that two tablets don't do the trick anymore, won't they be more inclined to take a third or even a fourth, thereby equaling or exceeding the current recommended maximum dose? Alternatively, they may switch to other over-the-counter pain relievers, such as aspirin and ibuprofen, which have their own overdose risks.  As one panel member told The New York Times, "If you keep track of what you're taking, none of this is an issue for you."

Reason coverage of the conflict between drug control and pain control here.


NEXT: A Brief Reminder that Models Aren't Always Right

Editor's Note: We invite comments and request that they be civil and on-topic. We do not moderate or assume any responsibility for comments, which are owned by the readers who post them. Comments do not represent the views of Reason.com or Reason Foundation. We reserve the right to delete any comment for any reason at any time. Report abuses.

  1. Does anyone know why specifically they add the acetaminophen to Vicodin & Percocet? DEA, FDA, or did the drug companies themselves just realize that MDs would be more willing to prescribe the opiates when combined with acetaminophen?

  2. What’s truly infuriating about this, especially as someone who suffers from chronic injury-related pain, is that I see nothing about what they might replace these with. Will they come out with Tylenol-free hydrocodone, for instance, like oxycontin is for oxycodone?

    I swear, the people in government are sadists. It’s like they want people to be in pain.

    Also note that if they ban these common painkillers that are given out after every wisdom tooth removal or broken bone, the black market in them will go through the roof.

  3. Does anyone know why specifically they add the acetaminophen to Vicodin & Percocet?

    It is specifically to curb abuse, though they make noises about a (non-existent) synergistic effect. However, curbing abuse with lethality is so twisted it boggles the mind.

  4. I’d love some acetaminophen-free hydrocodone.

  5. It is specifically to curb abuse

    OK. I was wondering if the feds mandated this, or if the drug companies did it voluntarily.

    Although, thinking about it now, “voluntary” can be a flexible concept where the feds are concerned.

  6. Cold water extraction, wingnutx, and you have your (mostly) acetaminophen free opiates.

    Which just goes to show how additionally idiotic adding the Tylenol is, and then attempting to ban it.

  7. However, curbing abuse with lethality is so twisted it boggles the mind.

    I wish i was surprised that pureaucrats would be willing to destroy people in order to save them, but i am not. Not even a little bit.

  8. This shit is bananas. Fuck you very much, Richard Nixon.

  9. Every time a doctor says “Try Tylenol, it’s very effective for pain,” I think about junkpunching them until I pop one of their crunchberries and seeing if they reach for APAP or something, you know, effective. I don’t have that reaction with women doctors, but I do believe that the proper term of address should be “Doctoress.”

  10. But NutraSweet, try some tramadol! Just because it fucks up your sleep (amongst other things) is no reason to not prescribe it over Vicodin!

    It’s the DEA that should be punched in the junk, as they have the doctors scared shitless.

  11. Well, I can only really imagine the junk in the room, not some hypothetical DEA junk.

    Tramadol? I had it under the name Ultram and I wasn’t impressed.

    I guess I know why you take it:

    Off-label and investigational uses

    * diabetic neuropathy[7][8]
    * postherpetic neuralgia[9][10]
    * fibromyalgia[11]
    * restless legs syndrome[12]
    * opiate withdrawal management[13][14]
    * migraine headache[15]
    * obsessive-compulsive disorder[16]
    * premature ejaculation[17]

  12. Hypothetical Junk is another good band name.

  13. “Will they come out with Tylenol-free hydrocodone, for instance, like oxycontin is for oxycodone?”

    They already exist. Hydrocodone is combined with aspirin and ibuprofen and marketed under different names. Don’t know the exact name brands off the top of my head, Lortab maybe??

  14. The change therefore would sacrifice the interests of consumers who follow instructions for the sake of consumers who don’t.

    Can we just incorporate this in the Great Seal of the United States, and be done with it?

  15. I’m a band name generator today. Sleep deprivation does that to me.

  16. my favorite slutty, all girl metal band

    Torque Wench

    no I didn’t spell it wrong

  17. Stuff like this article makes me wanna share my chronic pain. So the do-gooders can feel some empathy for folks with severe chronic pain.

  18. Tramadol? I had it under the name Ultram and I wasn’t impressed.

    Because it sucks. Though, if you take 4 at once before going to see Watchmen in Boston and then drink a Dogfish Head 90 Minute IPA just before the movie, you get pretty wasted.

    And for the record, I take tramadol to ease the pain of reading your tortured prose.

  19. Our dear Mayor is correct, but as to the larger question, there is no current product like oxycontin for hydro. This concerns me as I have a hypersensitivity reaction to oxy. I gets me good and high and gobbles up pain like Pacman on meth, but it also depresses my respiration, an effect that almost killed me when I was three.

  20. And for the record, I take tramadol to ease the pain of reading your tortured prose.

    Fair enough.

  21. Seems like people in chronic pain are overrepresented even more than people from the Bluegrass State here on H&R.

  22. HoneyBunny,

    I don’t have chronic pain, thank goodness. That’d be a nightmare. I’d just like pain meds when I’m in pain.

    I completely tore a tendon lose in my shoulder and they sent me home with fucking Advil.

  23. I may have to switch back to the cyanide-laced Tylenol.

  24. Aw, man. Karl Malden is dead too. This has been a rough few weeks on celebrities.

  25. Does anyone know why specifically they add the acetaminophen to Vicodin & Percocet?

    To highly discourage self-injection.IIRC,if you step on the junk with tylenol it is schedule III. Just the good stuff with a little insoluble binder and filler and it is schedule II

  26. Can’t we just let the dumb mother-fuckers die?
    Is that too difficult? Just kinda thin the herd a bit?
    Ultram is more useless than my pecker. As are all the designer non narcotic “pain relievers” the companies are cooking up today.
    I hope these dumb cunts aren’t having kids. I hate the thought of hyperventilating shitbags beeing breeders.

  27. I completely tore a tendon lose in my shoulder

    Ahh, the fateful ice-lifting incident. Not as glamorous as being shot in the nards.

    Back in my pharm tech days, the people with chronic pain (one with horror-movie migraines) were no joke. And on top of everything else, if the pharmacist didn’t personally know them, they were also subjected to the skeptical third-degree before getting their meds.

    They saw themselves as the ever-vigilant last line of defense against… someone getting high, I guess.

  28. Being pretty much immune to pain and injury, I have never had a strong painkiller prescribed to me by a doctor. But being curious I tried hydrocodone last week to see if I was one of these opiate sensitive types. Honestly don’t see what the big deal is, no euphoria, just a slight dizziness ( and I took 4 pills = 40mg). Anyone here take opiates not for the pain relieve but to get high?

  29. Anyone here take opiates not for the pain relieve but to get high?


  30. “If you keep track of what you’re taking, none of this is an issue for you.”

    People can’t be trusted with that! We need another new csar/tard to keep track of what you’re taking, via centralized medical records, already in the pipeline!

  31. 3 words…. cold water extraction. basically break up the pills. grind to a pwder, place powder in a glass of ICECOLD water, stir, filter with a coffe filter, and violia apap removed. it has to do with the soulubiltiy of acetaminophen in cold water, which is near nill. and the fact that the opiates are souluble in cold water. if done right it will take about 90% out and make large doses safe.

  32. Haven’t had any close-calls with overdosing on weed yet. Think I’ll stick to that.

  33. I”m sorry but if you kill yourself by overdosing on Tylenol you’re too stupid to live and deserve you’re Darwin Award.

  34. If they are really serious about protecting the retarded from themselves, they should take the Obama voters out into the street.

  35. My wife sees jaundiced junkies in the ER all the time. Dead livers. I’m sure this isn’t about folks taking this with a prescription who could otherwise get a different preparation, but rather people getting pills on the black market to get high. Apparently it’s really easy to OD on the Tylenol trying to get off on the narcotic. It doesn’t make much sense to have Tylenol in there to begin with. It’s like gluing a marshmallow to your dash to help out the airbag.

  36. Oh, screw these assholes.

  37. “…if they reach for APAP or something, you know, effective…”

    SugarFree, APAP is Tylenol. It’s also called paracetamol or acetaminophen. As Wikipedia states,”in some contexts, it is simply abbreviated as APAP, for N-Acetyl-Para-AminoPhenol.”

    Those contexts are usually on the label of some generic for Vicodin or Percocet. As a chronic pain patient for over a decade, I know my stuff. I will not take any drug, OTC or prescription, with that liver killing shit in it. Only straight synthetic opioids for me, thankyouverymuch.

  38. thanks a lot to the assholes who don’t know what cold water extraction is.
    it is going to get a lot harder to get pain treated. there is the possibility that vicodin, percocet, tylenol with codeine, ultracet, and darvocet might just get a black box warning. if they actually take them off the market that means they are going to have to write a schedule II script or treat the patient with an inadequate analgesic like tramadol or codeine.
    fuck the FDA and the DEA.

  39. Dylboz,

    I think you misunderstood my comment. I was lampooning the notion that APAP is an effective pain killer for any source of major pain. It is a separate issue from the adulteration of opiates with APAP, which I, of course, oppose.

  40. Tramadol makes me throw up, aspirin, naproxyn, and iboprofen are contraindicated with my ulcer.

    I’m stuck with tylenol and tylenol 3 for my chronic pain.

Please to post comments

Comments are closed.