FDA Considers Banning Acetaminophen-Based Pain Killers 631
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."
not really a ban (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)
If You Drink Alcohol Avoid Acetaminophen (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.
Doctors orders (Score:4, Informative)
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.
Re:If You Drink Alcohol Avoid Acetaminophen (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
Re:What will kill pain then? (Score:4, Informative)
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.
Re:not really a ban (Score:4, Informative)
This is not a ban (Score:3, Informative)
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.
Re:not really a ban (Score:5, Informative)
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.
Re:I for one (Score:5, 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.
Re:not really a ban (Score:5, Informative)
Thanks, but it's too late for me. (Score:3, Informative)
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.
Re:Why BAN and not WARN? (Score:1, Informative)
Re:So wait... (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.
Re:But for what durration? (Score:5, 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).
Re:not really a ban (Score:5, 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!
Re:As someone with a lortab prescription... (Score:2, Informative)
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 [wikipedia.org], not the acetaminophen.
Re:Doctors orders (Score:2, Informative)
Re:If You Drink Alcohol Avoid Acetaminophen (Score:5, 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.
Re:not really a ban (Score:5, Informative)
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.
Re:If You Drink Alcohol Avoid Acetaminophen (Score:5, 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.
Summary is factually wrong; daily limit is 4000mg (Score:2, Informative)
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.
Re:not really a ban (Score:2, Informative)
http://en.wikipedia.org/wiki/Vicodin#Pharmacokinetics [wikipedia.org]
I recently had surgery and was given clear instructions about avoiding anything with acetaminophen while taking Vicodin. If adding a little acetaminophen reduces the amount of narcotic needed, I think that is a good idea, as long as instructions are followed.
I would think all the OTC remedies that mix acetaminophen in with every known variety of other drug would be a much greater problem w.r.t. acetaminophen overdose.
This will only cause more problems. (Score:1, Informative)
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.
Re:not really a ban (Score:5, Informative)
Re:not really a ban (Score:3, Informative)
Hydrocodone is very mild compared to oxycodone. Oxycodone has something like 3000 (IIRC from medicinal chemistry well over a decade ago) times the affinity for the relevant receptor sites in the body as hydrocodone. Taking 30 oxycodone tablets is far from harmless... untreated, it would likely be fatal, as you'd stop breathing. Of course, it's illegal to take oxycodone in any manner other than as directed by a physician, so we don't have to worry about that, right? Right?
Anyway, here's the deal:
Ask your doctor before you take any medication in conjuction with a prescription medication. At the very minimum, ask your pharmacist (the pharmacist will have better knowledge of potential drug interactions, but poorer knowledge of your personal medical situation). I'd do both.
Re:What will kill pain then? (Score:2, Informative)
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.
Re:not really a ban (Score:3, Informative)
Not Banning Acetaminophen-Based Pain Killers (Score:3, Informative)
Re:not really a ban (Score:1, Informative)
Re:not really a ban (Score:4, Informative)
The guaifenesin isn't really in there as an expectorant. It's in there because if you chug the whole bottle, the guaifenesin will make you throw up, discouraging you from using the dextromethorphan to get high.
I'd rather take it with with theobromine [wikipedia.org] than dextromethorphan.
Re:not really a ban (Score:3, Informative)
Acetaminophen has a lot of uses, actually. In recommended doses, it's perfectly safe and doesn't cause any liver damage. It's only when you combine it with other things or OD that it becomes problematic.
Unlike aspirin, acetaminophen is safe for children as it doesn't cause Rhye's syndrome. It's safe for pregnant women. It doesn't irritate stomach lining and so is safe for those with gastric ulcers.
It's method of operation is unlike other drugs (especially opiates) and the combination leads to less amount of both needed to produce the desired effects, which is why they combine it with those drugs. Hell, the stuff even works effectively in combination with aspirin (aka Excedrin), leading to a greater effect with less total dosage of either individually.
The fact is that acetaminophen is practically a miracle drug. It works incredibly well with virtually no side effects. Unfortunately, the effective dose happens to be rather high when compared to the damaging dose (1/16th) which is unlike most other drugs (most other drugs fall into the 1/30th to 1/50th range).
Anyway, I'm against the law banning any particular drug in general, because there may be an effective use of that drug in specific cases. My medicine should be between me and my doctor, not subject to government dictates.
Citation Provided (Score:5, Informative)
Re:Doctors orders (Score:1, Informative)
More children are hospitalized -- every year -- for Tylenol complications than ever contracted Reye's Syndrome in entire history of the disease.
OMG kill it! (Score:4, Informative)
"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.
Re:If You Drink Alcohol Avoid Acetaminophen (Score:3, Informative)
It's actually the 2nd step in alcohol metabolism, the aldehyde dehydrogenase that uses up reducing equivalents. Here's a nice summary [ceri.com] of what happens.
Re:I for one (Score:3, Informative)
Re:Alcohol (Score:3, Informative)
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.
Re:not really a ban (Score:2, Informative)
Yes, any half-way intelligent person SHOULD know not to take tylenol, but there's many thousands of accidental overdoses every year in emergency rooms all over the country. Some of these people get all upset and blame the government for making it OTC and not warning them if eating the whole bottle can kill you. Yes, their logic is pretty bad, but the public can be stupid.
Your list is inaccurate, the FDA did warn about many of these drugs, but they were not banned. Avandia is still on sale today, as well as in formulations like AvandiaMet. Vioxx was voluntarily pulled from the market by Merck and not the FDA, which probably would have been fine with it as long as it had some sort of black box warning on it.
Umm, that's the POINT.. to be toxic. (Score:4, Informative)
Re:not really a ban (Score:3, Informative)
Tylenol is no deadlier than any other drug on the market.
From memory from a course I did at university, Tylenol (or Paracetamol, as we call it here) has a very low therapeutic index (ratio of lethal to effective dose), which is unusual for a drug which is commonly used by many people. It happens to be quite a big cause of liver damage worldwide. This wikipedia page [wikipedia.org] seems to agree with that, suggesting a toxic/effective ratio of about 10.
Unfortunately, I can't find other web references for this, can anyone else help out by linking to a list of LD50/ED50 ratios for drugs (in particular, Tylenol)?
FWIW, here's one [clusterbusters.com], which has the following ratios:
psilocybin (psychadelic mushrooms): 641
vitamin A: 9637
LSD: 4816
aspirin: 199
nicotine: 21