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FDA Considers Banning Acetaminophen-Based Pain Killers

Greg George writes "The FDA has determined that Tylenol enhancing pain killers are dangerous enough to potentially be pulled from the market. Drugs including Vicodin, Hydrocodone, Lortab, Maxidone, Norco, Zydone, Tylenol with codeine, Percocet, Endocet, and Darvocet may be permanently banned from the US market, even if the patient has a prescription from a doctor. The problem is the key ingredient — acetaminophen — can easily damage or destroy a patient's liver if more than 2000 mg are used per day. In many cases that means if you take a pain killer and then take two extra strength Tylenol, you may have gone over the maximum dosage per day."

15 of 631 comments (clear)

  1. not really a ban by mr100percent · · Score: 5, Informative

    Before everyone screams bloody murder, the fact remains that you'll still be able to buy the stuff, separately. Percocet, for example, is actually a mix of oxycodone and acetaminophen. You can buy them separately as Oxycontin and Tylenol (or paracetamol in the UK).

    It's the combination that causes problems; people wind up overdosing. Overdosing on the oxycodone portion is not all that dangerous (you could swallow 2 dozen of them at once though I would definitely not recommend it) compared to Tylenol, which can damage your liver. Thirty extra-strength tylenols at once can destroy your liver and you'll die within 72 hours. These medications have acetaminophen in them as an an anti-inflammatory to work with the painkiller, but they wind up being the deadlier part of the drug since people take too much. A few people think they can commit suicide by swallowing the whole prescription, but what happens is the codeine-based painkiller part wears off in hours and then the agonizing abdominal pain of liver failure begins until they're dead 3 days later.

    You'll still be able to buy the separate ingredients, hydrocodone is Vicodin and Norco, oxycodone is Percocet, etc. There are other formulations; Percodan is nearly the same as Percocet except it uses aspirin in place of acetaminophen (Tylenol)

    1. Re:not really a ban by BrokenHalo · · Score: 5, Informative

      Thirty extra-strength tylenols at once can destroy your liver and you'll die within 72 hours.

      If you're lucky. Things have a tendency to go wrong with this course of medication, resulting in a fucked liver and a death spread over several weeks. It happened to my sister-in-law, and it's not pretty.

      If you want to kill yourself, I'd suggest a nice clean OD on smack.

    2. Re:not really a ban by Bitch-Face+Jones · · Score: 5, Informative

      I'm not so sure about that. One of the reasons that drug companies put acetaminophen in things like hydrocodone and dextropropoxyphene in the first place is because they make it more difficult (ironically) to overdose on or use recreationally. If you try and just down 12 vicodin at once, all of the acetaminophen in it is going to make you pretty sick, so you have to jump through quite a few hoops (like using a cold water extraction) if you want to get the good stuff out without having to deal with the acetaminophen.

    3. Re:not really a ban by ae1294 · · Score: 4, Informative

      Anyone taking medicine should know they have to check for drug interactions and overdoses. The medical industry has been harping about it for years. If the product they offer is safe when following the directions, then it's not their problem if people do stupid things with it.

      What I think is funny is that the FDA is spending all this time over something that any half-way intelligent person should already know or at a minimal their doctor should have told them. What about all the drugs that they approve as safe that turn out to kill large numbers of people when they take the proper dose? eh? Maybe the makers of Tylenol are late on their hush money payment???

      Avandia - Glaxo SmithKline, Banned 03-2000 for; heart failure, hepatitis, and liver failure
      Baycol - Bayer AG, BANNED 08-2001 for fatal rhabdomyolysis
      Bextra - Pfizer, BANNED 04-2005 for; heart attack, stroke, skin diseases
      Dexatrim - Bayer, BANNED 11-2000 for fatal strokes
      Ephedra - Brayton Purcell, BANNED 04-2004 for; high blood pressure, heart rate irregularities, insomnia, nervousness, tremors, seizures, heart attacks, strokes, brain hemorrhages, and death
      Fen Phen - Wyeth, BANNED 09-1997 for; heart valve damage, primary pulmonary hypertension
      Lotronex - Glaxo SmithKline, BANNED 11-2000 for; ischemic colitis, abdominal pain, severe constipation
      Pondimin - Wyeth, BANNED 09-1997 for; heart valve damage, primary pulmonary hypertension
      Propulsid - Janssen, BANNED 03-2000 for; torsades de pointes, SIDS
      Redux - Wyeth, BANNED 09-1997 for; heart valve damage, primary pulmonary hypertension
      Rezulin - Warner-Lambert, BANNED 03-2000 for severe liver toxicity
      Vioxx - Merck, BANNED 09-2004 for; heart attack, stroke

      This is only the short list... Thank you FDA for protecting us and the children!

    4. Re:not really a ban by DurendalMac · · Score: 5, Informative

      Acetomenaphine is the only OTC painkiller that is safe for pregnant women to take AFAIK. Aspirin is a big no-no and Ibuprofen is iffy at best. It's always good to have options. You can burn a hole in your stomach with too much Ibuprofen. Should that be pulled from the market too?

      Bottom line: READ THE DAMN LABEL. Make sure you're not taking too much. Check with your doctor if you're not sure. A lot of medications will screw you up if you take too much. Equip yourself with knowledge and you'll be fine.

    5. Re:not really a ban by businessnerd · · Score: 4, Informative

      I really have to second this idea, but not just painkillers. Every medication has a label with extremely specific guidelines on how to take it (or not take it). Those labels go through painstaking copy review to make sure that the user has the tools to take the medication safely. But almost nobody reads them. For example, one day my wife missed two days of her birth control and didn't know what to do, so she was just going to come up with something on her own. I told her she should read the label and see what it says. She's been taking birth control for years and has never bother to read it. I read it and it said exactly what to do in every type of situation of missed pills at various points in the cycle and each situation had different instructions. It's a good thing I read it because she was planning on doing what was NOT recommended. While she wasn't in danger of overdose or anything like that, this type of drug messes around with your cycles which can cause a whole mess of uncomfortable issues or pregnancy (totally not ready for that). Everyone has been in a situation where they weren't sure what to do with their meds so they just guessed, but if they read the damn label it would tell them exactly what to do. Every time you get a new medication, sit down and read the label. It can be a surprisingly interesting read.

      --
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  2. If You Drink Alcohol Avoid Acetaminophen by eldavojohn · · Score: 5, Informative

    The problem is the key ingredient - acetaminophen - can easily damage or destroy a patient's liver if more than 2000 mg are used per day.

    Disclaimer: Not a doctor or med student but my three sisters are nurses/researchers.

    My older sister warned me when I started college that if I was going to drink I should avoid acetaminophen at all costs. Luckily, I don't get headaches or have had a need for a painkiller in a very long time and I think it's been about six years since I've taken them. If you are a heavy drinker, avoid acetaminophen as your liver's already dealing with the alcohol and crap in the American diet and doesn't appreciate it. My sister told me that people who use acetaminophen during hangovers may be putting themselves at a much higher risk for liver diseases. I'm a little concerned these have been out for this long when there's safer alternatives. I'm sure the companies that stand to profit have tons of tricks up their sleeves yet.

    --
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    1. Re:If You Drink Alcohol Avoid Acetaminophen by mr100percent · · Score: 4, Informative

      This is true. Any pharmacist will tell you to take Motrin or Advil (Ibuprofen) instead, as it skips the liver and is not nearly as toxic

    2. Re:If You Drink Alcohol Avoid Acetaminophen by Hatta · · Score: 4, Informative

      Alcohol damages the liver as it's broken down and so does acetaminophen

      Not necessarily. Normal metabolism of either alcohol or acetaminophen isn't damaging, but it uses up reducing equivalents (such as those sulfhydryls on methionine and cystine). It's only when those reducing equivalents are used up that acetaminophen is shunted into another metabolic pathway that it produces toxic metabolites. In moderation drinking alcohol xor taking acetaminophen is safe.

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    3. Re:If You Drink Alcohol Avoid Acetaminophen by Hatta · · Score: 4, Informative

      Oh, I should have mentioned this. Aspirin and ibuprofen can damage the stomach lining, and drinking alcohol thins the blood which can increase the risk of stomach bleeding. Best thing to do for a hangover is to drink water and coffee and smoke some pot. If you absolutely must take an analgesic, use ibuprofen it doesn't thin the blood as much as aspirin does.

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  3. Re:I for one by Freetardo+Jones · · Score: 4, Informative

    Do not welcome our nannystate overlords.

    Seriously why do we have to keep legislating everything.

    When did the FDA become a legislative body? Did I miss that?

    Soon after Government run healthcare they are going to tell you want you can and can't eat.

    And yet in countries with publicly funded health care the government doesn't do that. It's almost as if your comment is just plain bullshit.

  4. Re:So wait... by phizix · · Score: 5, Informative

    The FDA made the drug companies put acetaminophen into the narcotic painkillers to keep people from recreationally overdosing on them (same as they "denature" ethyl alcohol that you can buy at the hardware store by poisoning it with methyl alcohol)...

    This is not true at all. Acetaminophen and narcotics are mixed because the combination is a much more effective pain reliever than either alone.

  5. Re:But for what durration? by Dr_Barnowl · · Score: 4, Informative

    This is one case where it's counterintuitive.

    Your liver makes acetaminophen into some really nasty toxic shit, and that's what damages it. Fortunately, it has another metabolic pathway that detoxes the stuff before it reaches toxic concentrations.

    This pathway is powered by a limited stock of glutathione in the liver. When you run out, the toxic products start to accumulate rapidly and cause acute liver failure. Up until that point you are suffering no significant ill effects. Therefore you could take a therapeutic dose for extended periods with little ill effect, it only causes a problem when you overwhelm your capacity to produce glutathione.

    Acetaminophen is the number one cause of acute liver failure in the USA and UK, but is not noted for causing chronic damage (or it would certainly not be available over the counter).

  6. Citation Provided by Tyler+Durden · · Score: 4, Informative

    See here. It states in part that combining hydrocodone with other substances changes it from a Schedule II substance to a less restrictive Schedule III substance. The two example drugs they cite for this are Lortab and Vicodin - both containing acetaminophen.

    --
    Happy people make bad consumers.
  7. Umm, that's the POINT.. to be toxic. by dickmerkin · · Score: 4, Informative

    I've worked in a liver transplant unit, which is where Tylenol poisoned patients land... The whole idea is to make drugs like vicodin toxic in high doses and lethal IV. These are called "Compounded" drugs. They have a maximum dose, over which it becomes toxic. Drugs like oxycontin have no maximum dose (if you are adequately physically tolerant to opiate drugs) It's like similar to the practice of adding an adulterant (e.g. isopropanol, methyl ethyl ketone, methanol, etc ) to ethanol to make it undrinkable. In addition to Tylenol, atropine and aspirin are used as adulterants. The theory is that they will have less value to opiate addicts and it works. Compounded drugs are worth less on the street than uncompounded drugs. Almost Invariably, people who OD (not counting suicide attempts) on the Tylenol portion of a compounded drugs are abusing it. Furthermore, they are usually malnourished alcoholics who already have underlying liver disease... Last of all, most people aren't as susceptible to Tylenol toxicity as the people who get into trouble. I've seen quite a few addicts who were downing 40 pills a day of percocet or vicodin, with no ill effects.