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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."
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)
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.
My work here is dung.
Which is why my doctor tells me not to take any medication containing acetaminophen other than those prescribed, and the form I have to sign when I pick my prescriptions repeats that warning.
All this ban is saying is that you can't buy the drugs as an all-in-one formulation. You can still buy them just the same as separate pills.
What is being proposed is not a wholesale ban on acetaminophen but a ban on *some* drug combinations that include it and a reduction in the maximum OTC dosage. The drug will still be available and you'll still be able to mix drugs yourself to get the old effect.
I am becoming gerund, destroyer of verbs.
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.
Even though I was concerned about taking the maximum daily limit of vicodin and then percocet, my doctors dismissed my concerns as all they really care about is treating my spine/nerve damage. Well now that my pre-surgery tests show that my enzyme levels were high, you would think that my neurologist and neurosurgen would care. Nope.
After switching doctors, my new neurologist has the same careless attitude towards how many percocet that I take daily. My he proscribes up to 6-500 mg per day. According to this recommendation I feel bitter about towards the highly uneducated pimps that call themselves doctors. So not only was my spine surgery not successful I know have to deal with liver damage.
Everyone keeps saying 2000 mg limit. My doc said 4000 mg was the limit and to never take more than 8 vicodins a day. 5 mg hydrocodone and 500 mg APAP. I have taken that many in a day and never had a problem. Blood and urine tests show all systems functioning normally. Whatever. Just get the norcos. They are 10 mg hydro and 325 mg APAP. Then you can take like 15 a day and still be ok. That's a lot of hydro though.
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.
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).
My prescription is 7.5mg hydrocodone, 500mg acetaminophen (standard - though there are a few variations on the amount of hydrocodone). The FDA has enforced that amount of acetaminophen, for two reasons. Hydrocodone is relatively addictive, and acetaminophen often induces a huge amount of nausea.
Generally, it is the narcotic causing the nausea, not the acetaminophen.
2000mg is not the daily limit for acetaminophen; 4000mg is. 2000-3000 is the limit for "at risk" populations (e.g. existing liver disease). The linked article doesn't even mention a dosage limit. You can take your 2 Percocets and 2 extra strength Tylenol and still be under the dose limit; that's only 2300 mg even with the high-dose Percocets.
It's one thing to be concerned about an overdose and set a dose limit; it's a completely different thing to arbitrarily lop the max dose in half to cause hysteria.
As a pharmacy student I can tell you that Acetaminophen is there mainly to prevent the abuse from the harder opiate drug. If patients try to abuse the acetaminophen containing drug they'll most likely get sick from the acetaminophen before they get too high off the painkiller, thus preventing abuse. If these drugs are pulled from the market, I can only see the separate drugs (oxycodone, hydromorphone) being prescribed with the doctor telling the patient to take it with Tylenol. This opens up the fact that patients are more likely just to take the opiate drug without the Tylenol, getting addicted, and causing even more problems.
It's the responsibility of the pharmacist to tell the patient how much acetaminophen to take in a day. I've been taught and trained to counsel the patient that they can only take a maximum of 8 per day (based on if a tablet of Vicodin has 500mg of acetaminophen, for example) because of the liver problems that acetaminophen may cause. And last I checked, maximum daily dosing on acetaminophen was 4000mg per day, not 2000.
You can get a script for just hydrocodone or oxycodone, but doctors don't like to prescribe them because of DEA pressure. Oxycontin is oxycodone plus acetaminophen (like percocet) but is time released.
They are not. They are considering banning combination drugs that include acetaminophen, because there have been fatal overdoses when people additionally took acetaminophen.
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.
"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"
1. Vicodin is Hydrocodone
2. None of these painkillers require APAP to function, the anti-inflammatory effects of acetaminophen are auxiliary. The primary reason APAP is added to these drugs is to make them difficult to take in doses addicts can appreciate.
3. Acetaminophen is STILL effective at what it does and despite the misuse of it from ignorant users it is less harmful to the lining of the stomach than aspirin, does not increase the risk of people taking lithium or have sodium sensitivity like naproxen, and is not as definitely fatal in case of overdose as ibuprofin.
Acetaminophen is not perfect, but there's no perfect alternative and that is the very reason why we need to sustain as many options as possible for the diversity of medical needs people have.
"Most people, I think, don't even know what a rootkit is, so why should they care about it?"
I normally wouldn't correct something like this, but this is /. so minor technicalities cannot go uncorrected. The DEA, not the FDA, determines which CSA schedule a drug is placed in.
Taking the daily recommended maximum dose of alcohol will not destroy your liver.
Taking double the daily recommended maximum dose of alcohol will not destroy your liver.
Taking triple the daily recommended maximum dose will not destroy your liver.
Alcohol will cause acute CNS depression and kill you long before it causes acute liver damage. Only chronic abuse allows it to scar your liver. The same is not true of acetaminophen.
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.