The U.S. Food and Drug Administration voted Tuesday to reduce maximum recommended doses of the pain-relieving drug acetaminophen, which is one of the most widely-used drug in the country as the active ingredient in Tylenol and a wide variety of other over-the-counter medicines.
In the same series of votes, the FDA also rejected a move to ban NyQuill and other medicines that mix acetaminophen with other drugs. The panel ecommended phasing out the prescription drugs Vicodin and Percocet.
"[Overdoses] of acetaminophen have been linked to 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths during the 1990s" according to a study cited by the FDA, reported CNN. The government agency said acetaminophen is the leading cause of liver failure, even outpacing alcohol.
By a vote of 21-16, the panel recommended 650 milligrams become the new maximum over-the-counter dose of the drug, curbing the current maximum of 1,000 milligrams.
The vote could mean stronger overdose warnings will be applied to Robitussin Cough Cold & Flu, Tylenol, Theraflu, Vicks 44 and NyQuil, among other medicines that contain acetaminophen.
The FDA is not required to act on the panel's vote, which is considered a recommendation.
-- Stephen C. Webster
Two hundred people? What's next curfews during thunderstorms? 20 of those are from OTC cold medicines. This is ridiculous. What about crash helmet legislation, make everyone wear one at all times, its along the same line of reasoning?
"sending 56,000 people to the emergency room annually, "
Number still too low, PC?
What this article, and perhaps the FDA study, is lacking is a number on how many are the result of taking acetaminophen in a "combined" medication and how many are from just acetaminophen pills (which this action will not help).
I don't think it's responsible to add acetaminophen to a liquid cold medicine but, because the numbers don't separate out the cases (compound or single-use acetaminophen ) I'm left in doubt this action will save many people grief. All regulation is costly and there needs to be a clear reason for it... besides the general attack on personal liberty (which is bad enough).
I've been generally disappointed in the FDA as a scientific body (for many reasons) and really have to wonder if they haven't conflated the high numbers with liquid cold medications in this case... yes, I think they are that stupid.
Well, I'm the one who'd stupid in this case... not finishing the article before sounding off!
But it is as I suspected... probably an expected 10% improvement.
"Only 10 percent of deaths linked to acetaminophen medications involved over-the-counter combination cold medications, according to the Consumer Healthcare Products Association."
I wouldn't take one of those witches brew concoctions in the first place.
Okay. I'm allergic to Advil, Ibuprofen, Aspirin and Bufferin. The only thing I can take is Tylenol. What about me?
Brian - you could still buy pure acetominophen. They're just trying to stop them from mixing it with other medications so that people unknowingly ingest fatal or liver-damaging amounts of acetominophen.
Thank god it's the FDA voting and not our corrupt democratic senators will side with the pharmaceutical companies regardless of the danger to public health.
and yet they still allow the over the counter sales of ingredients for the manufacture of meth.
way to stay current there, FDA. I'm so glad they are banning something at actually works! I mean really, it's not like they are banning this stuff so the pharma corps can make more money with a new, lesser strength product, right? RIGHT?
Nyquil is probably one of the best selling cold meds out there at actually works. Do you honestly believe the FDA would ban this without consulting the makers? And greasing their palms? And funding a new drug?
Come on, I have a bridge to sell you.
Do you get it????? You have to go to the Doctor now for a Rx of aspirin!!!
The Medical Industrial Complex rulez again. I would blame the illiterate idiocracy for this new rule but I am familiar with Codex Alementarius which will prevent us from using any "medicine" on our own.
Zieg Heil NWO!
Why don't they outlaw acetaminophen altogether? Just another case of Big Pharma paying the way of the federal regulators that are supposed to keep the Corporate Feudalists from poisoning us all. I can hardly wait 'till they start importing tylenol from China. That will take care of our population problem!
Brian,
No one is talking about banning Tylenol. This potential ban only applies to combination meds like Nyquil. Since some people don't read drug labels (or news articles) carefully, they will take Tylenol itself plus something containing Tylenol, such as Nyquil and overdose, thus damaging their liver.
A college friend of me died in his 30's (in the 1980's after the Tylenol poisonings) because he had a bad back and took Tylenol and drank some beer most days. He left behind a toddler son.
His family told me that they believed Tylenol was the cause but at that time there was total silence on its dangers and no liability to Tylenol. Then I realized that the Tylenol poisoner must have lost a loved one to Tylenol's liver destruction -- and faced the total lack of justice and media/FDA silence. There was total public silence about the dangers of Tylenol for a very long time. So the Tylenol poisoner took it upon himself to publicize the natural danger of Tylenol poisoning to anyone who drinks alcohol. But if he was trying to alert the public to Tylenol's ability to blow out a person's liver, he failed. The media told the public the motive for the poisonings was mysterious.
The grammar typo is so egregious I must correct it: "a college friend of mine"
I was talking to a friend of mine and he has a relative who took tylenol and drank some wine and may die.
Even without alcohol tylenol is the leading cause of live failure.
http://www.straightdope.com/columns/read/2354/does-tylenol-alcohol-liver-failure-plus
obsessed writes
"Thank god it's the FDA voting and not our corrupt democratic senators will side with the pharmaceutical companies regardless of the danger to public health."
Seriously, are you retarded? This is not some big killer. If you need to put a warning label on it for idiots fine, but this is just a scam to make you go to a doctor for one more thing. We will eventually have to go for colds, flu, and headaches. This is getting ridiculous, of course tools like you only see it as big Pharma vs the People when it is actually doctors getting more action. Of course the doctors and big Pharma aren't at odds when it comes to prescribing every pill under the sun. Its all about money and interest groups, the people aren't in this discussion at all.
I loe Nyquil for a cold, it works better than anything to get you to sleep, But it is a combination of Alcohol and tylenol, is it not?
I also lost a freind due to mixing tylenol with another OTC drug. That was 20 years ago. Needless to say we were all shocked and stuck in a perpetual WTF scenario. How can someone die from taking OTC medicines?? She was young, vibrant, full of life....had two wonderful young children, a loving family, and tons of great friends. These dangers need to be publicized so that peoples lives can be saved!!
"We believe there is a clear health benefit of over-the-counter combination products containing acetaminophen,"
What is this health benefit? I can't combine acetominophen with a decongestant, a cough suppressant and an antihistamine myself? At less than half the price?
These combination products work because their individual ingredients work, not because it's some magic potion.
Even though I'm a family physician, I rely more on grandma's wisdom "rest, fluids, and soup" when I'm sick, but when I take something otc, it's one at a time, so I know what I'm treating.
No big loss if we take these combinations off the market--except to the bottom line of the companies and the media they support with their ads.
Brian,
"Procter and Gamble recently released naproxen under the brand name Aleve, joining the ranks of FDA-approved analgesics in the Rx to Non-Rx switch."
There, I googled it for you.
If you're allergic to that...maybe acupuncture?
How many people have overdosed on marijuana again?
Oh, that right...
Zero.
Cannabis for headaches: Little, Green, Different.
please dont ban theraflu
its the only thing that lets me sleep when i get sick
Is the FDA too blind to realize that it is Federal DEA/FDA nonsense that MANDATES acetaminophen (tylenol) to be included in most analgesics in the first place!!! No one else wants it. For example: Vicodin, Percocet, etc. Dear FDA (and DEA) just relax your own idiotic regulations that PREVENT manufacturers from selling single-ingredient products like Hydrocodone, Oxycodone, Codeine (with a few exceptions). It has never been customers who wanted the cheap and deadly APAP added to their medicine, it has been FORCED upon the public by the Federal Drug bureaucracy, in their brain-dead attempts to save people from themselves. They prefer that you die of liver failure (like the Anthrax fall-guy) before you have a chance to actually gain either pain-relief and/or pleasure from opiates! God forbid!! Our masters are poisoning us in broad daylight. What evil these policies do is beyond measure. Please FDA, just get out of the drug regulation business! We don't need your busy-body meddling, your nosy, moralistic interference and we don't want your POISON tylenol!! It's like the junk that's used to "de-nature" industrial alcohol.
This FDA is the same agency that prohibits the sale of pure hydrocodone tablets in the United States. Hydrocodone, for domestic distribution, must be compounded with acetaminophen (Vicodin, Lortab) or ibuprofen (Vicoprofen) so that hydrocodone abusers are faced with the danger of liver and/or kidney damage as a deterrent to their abuse. The disparity between this current policy and the proposed OTC regulation is absurd and hypocritical.
All drugs affect the liver. It's the livers job to detoxify the drugs and all drugs are toxic to one degree or another.
Taking acetiminophen with beer daily is a deadly combination. Beer alone daily takes a heavy toll on the liver also even w/o the acetiminophen.
The real problem if you read the article, is the stupidity & carelessness of the american public. They don't read & follow the instructions on how to use the products.
So the responsible people who do need & use these drugs properly, pay the price.
Must this country always play to the lowest common denominator???
Obviously looking to drum up camapign contributions from the manufacturers....pay us and you can keep selling your product...just like the liquor industry.
I am in constant pain due to spinal stenosis and age-related arthritis. My pain management doctor prescribes Norco which is a mixture of Hydrocodone and acetaminophen. I've asked him to give me something w/o the acetaminophen, but he tells me there isn't anything sans acetaminophen, which leaves me in a predicament, live my life in agonizing pain, or burn my liver out. Not much of a choice is it?
Get a NEW pain management doctor pronto!!!! Plenty of pain relievers without that bullshit. Most doctors tremble in fear of the DEA. Better to have suffering patients than an audit.
It is dangerous that the FDA requires adding acetaminophen to pain killers in products such as Vicodin. When I was being treated for cancer, I took Norco 7.5/375 6 times a day, receiving more than 50% of the 4000 mg maximum daily dose of acetaminophen. 4000 mg daily is toxic. All that toxicity delivered to the liver with absolutely no benefit thanks to the dangerous FDA requirement.
I am very lucky that I now have no evidence of disease and no longer take any pain medication. However, many have chronic pain for conditions for which there is no known cure. While Norco contains less acetaminophen per tablet than other Hydrocodone formulations, there are alternatives.
My wife, who has chronic pain from osteoarthritis, scoliosis, and sciatica, received a referral to a pain management specialist who prescribes Oxycontin that contains no acetaminophen, a real help for anyone who must take pain relief medication every day. Such patients are subject to random drug tests, but it is worth it to avoid subjecting the liver to acetaminophen.
The aceteminaphin scare is just the tip of the iceberg
Read this story from TEN YEARS AGO !!
April 15, 1998
Associated Press
CHICAGO/ Bad reactions to prescription and over-the-counter medicines kill more than 100,000 Americans and seriously injure an additional 2.1 million every year. Far more than most people realize, researchers say.
Such reactions, which do not include prescribing errors or drug abuse, rank at least sixth among U.S. causes of death ¯ behind heart disease, cancer, lung disease, strokes and accidents, says a report based on an analysis of existing studies.
The authors analyzed 39 studies of hospital patients from 1966 to 1996. Serious drug reactions affected 6.7 percent of patients overall and fatal drug reactions 0.32 percent, the authors reported in Wednesday's Journal of the American Medical Association (JAMA).
In the study, serious injury was defined as being hospitalized, having to extend a hospital stay or suffering permanent disability.
The most surprising result was the large number of deaths, the authors said. They found adverse drug reactions ranked between fourth and sixth among leading causes of death, depending on whether they used their most conservative or a more liberal estimate. In 1994, between 76,000 and 137,000 U.S. hospital patients died, and the "ballpark estimate" is 106,000, researchers said. The low estimate, 76,000 deaths, would put drug reactions sixth. The ballpark estimate would put them fourth, they said. An additional 1.6 million to 2.6 million patients were seriously injured, with the ballpark estimate 2.1 million.
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
This study was published over ten years ago!! How bad is it now?
The FDA continues to push more drugs onto more Americans than ever before, all the while pretending these drugs are safe and effective when, in reality, they are neither. Today's pharmaceutical industry is a massive fraud being perpetrated against the American people. The entire drug industry, including their FDA co-conspirator, has become the single greatest threat to the health and safety of the American people.
Drugs do not cure anything! They simply treat symptoms! they do not address the underlying (root) cause of health problems. All drugs have side effects, some of which can be worse than the original health problem you started with.
This is all very bad for people ......... but very profitable for Big Pharma!
I had a bad reaction to Nyquil. I only had taken the recomended dose. I was sleeping like a baby. I got up to go to the bathroom, and next thing I remember I was found face down on the hall floor by my husband. I had passed out. I was very lethergic, he called the ambulance. All I wanted to do was go back to bed. Needless to say, I'll never take Nyquil again.
Why don't they ban oxycontin?
Nyquil is one of the most abused over-the-counter meds. Young people drink it for it's sedative effect . . . "dry" alcoholics drink it for the alcohol hit. The problem is that it includes acetaminophen [Tylenol] and, when it is abused, people die. Tylenol is deadly taken in doses above the maximum daily allotment.
Hey! Thanks for the clarification. I had a feeling it was aimed at mixed concoctions but I couldn't be sure. Naproxin is fine. I've taken it with no reaction.
Thank god for medical marijuana.
453 deaths?! A couple of deaths "believed to be linked" to Ephedra in ten years and it gets yanked.
With reduced amounts of the drug in your over the counter drugs, it will take twice as much of Nyquil to do anything. At the same time it will cost you twice as much to get rid of what makes you sick. I'm seeing something scary about what this administration is doing in regard to healthcare. Why are they concentrating on this (taking to much of anything can kill you) and not other things. It's as if they are trying to reduce the ability of the drug to make you better and at the same time enrich the people who make it.
Cool..
So now, if I want something that actually works, I have to go to the doctor and get it prescribed to me.
Thxallot.
@Blue-eyed Videot: You can get oxycodone without the APAP; just ask your doctor for it. They do make it. I have had it and will probably get it again next time I need pain meds.
NSAIDs (largely ibuprofen) was part of what ruined my kidneys, and I know other dialysis patients in the same boat. Now all my doctor will let me use for pain is Tylenol and narcotics, and Tylenol really doesn't work for me at all. With the stenosis in my neck, unfortunately, I do need something sometimes. I did not realize that was what the APAP was, but now that I do know, I'll ask for my medications to be free of it next time. I can get plain oxycodone but I've yet to see plain codeine. (I don't take hydrocodone, as it gives me a migraine.) I will have to ask.
People seem to be under the impression that the restriction doesn't apply if there is a mixture of ingredients. The article made it clear that the upper limit is 625 mg rather than 1000 mg for all products containing acetaminophen.
As for those who think that just because it makes you feel better, then it should be allowed, I wonder what these people think with. They ignore completely the fact, one that has been known for quite some time, that acetaminophen is the leading cause of liver damage in the US. I strongly suspect that they will argue that they should be allowed to run that risk, but I bet they will want medical help paid for with someone else's insurance premiums when they lose the bet. These are people who should be in line for the Darwin awards.
Thanks for the info Nile_Liszt. We've got to get real about drugs and healthcare in this country. Too much politics in both. And the government needs to get off the people's backs with moralizing. Leave that to the churches. If you're sick and in pain you shouldn't be forced to rely on a drug that can have serious side effects. Pot's a whole lot better than anything big pharma has come up with; it's natural!
We need single-payer healthcare. Make the payment through taxes. The richer pay more, the poorest pay nothing. You pay a token fee to see the doc and get the drugs. I'm really disappointed in the Dems, including Obama. I expected more change, faster.
Well one thing I'm not alergic to and not yet approved by the government is cannabis, aka marijuhana or mary jane.
allergic
Well, we better start taking cars off the street, because they kill 115 people...A DAY. Over 42,000 people are rushed to the morgue every year because of auto accidents.
An cigarettes too. They kill over 1,200 people...A DAY. But, we don't see those being pulled off the market, do we?
Our government really needs to stop trying to mother us.
I had three major lung operations in one week back in May of 2007. While in the hospital, they were giving me IV pushes of morphine, but Percocet tablets worked much, much better.
Why not just take the Acet OUT of the Vicodin?
Oh, I know why - because Then people might cop a Buzz off of it, and goddess forbid That happen!
As a social worker I work with a lot of clients that have chronic physical pain, substance abuse problems, and often both. Vicodin and Percocet are two of the most commonly prescribed medicines for these clients. In fact, vicodin is given out like candy. Many of the clients abuse it by taking more than the prescribed dose either because it doesn't adequately relieve the pain or because they want to get high. Many of them take it in conjunction with alcohol and other drugs. As a result, many of them have time bombs for livers.
I've often wondered what the point is in holding back on more powerful pain killers. People that are going to abuse drugs are going to do it with or without your cooperation. Forcing people who are in chronic pain to live in pain because the doctor (or the govt) is shy about the possibility of them becoming addicted to a substance hardly seems humane, and adding toxins to dope for addicts seems counterproductive as well. If you're going to give someone codeine or an opiate, why lace it with something poison? How many kids have drunk an entire bottle of Nyquil to get the high from the alcohol and antihistamine while being essentially poisoned by the acetaminophen? In Great Britain heroin is prescribed by doctors in certain cases and their substance abuse rate isn't worse than in the US. Of course, they have good programs for treating addicts.
Acetaminophen is a useful drug. I can't take aspirin because of my delicate stomach, and acetaminophen helps with muscle and head aches. I also take cold remedies with acetaminophen but, being aware that mixing acetaminophen and alcohol is dangerous, I'm puzzled why my cold medicine almost always has alcohol in it. In the future, I think I'll take buffered aspirin, antihistamine, and have a shot of Jamesons in my tea when I have the flu.
"[Overdoses] of acetaminophen have been linked to 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths during the 1990s" according to a study cited by the FDA."
Deaths from Marijuana during the 1990's or any other decade: zero, zippo, zilch.
Lets see here there has never been a documented death from overdose of marijuana but Americans are doing life in jail for growing it, while pharmaceutical companies legally make billions of dollars on drugs that kill.
Example, Will Foster, an Oklahoma man whose 1995 arrest for growing medical marijuana attracted international attention after he received a 93-year prison sentence. Foster, who grew the marijuana to treat his rheumatoid arthritis, (The legal class of drugs for this Viox, Celebrex, ect. also kill) had been released in April 2001 after serving four and a half years, thanks to an appeals court that reduced his sentence to 20 years, making him eligible for parole. “A lot of people tell me I give them hope,” Foster said, “because I did have 93 years in prison, and now I’m free.”
Not anymore. The Drug War Chronicle reports that Foster has been behind bars for nearly 16 months in California, where he moved (with Oklahoma’s permission) after his release, because of a dispute over the terms of his parole. The story is a bit complicated, but the basic thrust is that California officials said Foster had completed his parole, while Oklahoma officials disagreed. In 2006 he successfully fought an Oklahoma warrant, but later the state issued a new warrant after Foster refused to agree to a retroactive four-year extension of his parole. That was not a problem until Foster was busted for growing marijuana by Sonoma County sheriff’s deputies. The cultivation charges were dropped after it became clear that the plants were for Foster’s own medical use, but he remains in jail awaiting extradition to Oklahoma, which wants him to complete his 20-year prison sentence.
“In their warrant, they said I violated the terms and conditions of parole in Oklahoma, then fled Oklahoma to escape justice,” Foster told the Chronicle. “But I haven’t been back in Oklahoma since I left in 2001. I successfully finished parole here, I beat back that earlier extradition effort, and they’re still coming after me.”
This looks like vindictive harassment of a man who has already spent a total of nearly six years behind bars for something that should not have been a crime to begin with.
When marijuana becomes legal many of these deadly "legal drugs" will not be needed. The problem any one can grow there own. No money for the legal pushers. That is why this American is in jail, and deadly drugs are legal,it all comes down to comes down $$$$$$$$$$$$,
……..any questions
I dunno what the fucking article said. But I can say several things.
1. When one needs codine, why the fuck does it have extra shit in there? e.g. hydrocodine?
2. Considering nobody has health care. Why ain't pot legal yet?
3. Why is this suddenly being pushed when nobody has health care and their income / money is at the fucking lowest?
4. Why when your teeth or b0rked arm, or chronic pain, is in pain is taking more than the prescribed shit wrong?
ANSWER... Cause the fuckers running our country are OATH BREAKERS!
Very good comments, nothing new to say about this except that Americans are pretty smart about what's going on.
Oh and considering Afganistan is the hell a fucking producer of opium (with us throwing in the towel) now, why the fuck can't we get CHEAP codine?
oKAY.. recap
free weed/POT/dope/marijuana
cheap codine/painkillers now!!!
OUTLAW crack/acet
for profit hospitals need to be outlawed
oH FUCK i FORGOT.. outlaw meth
Well i feared all of this for some time: big pharma and corporate med want us to have to go to the doctor for prescriptions for Tylenol,asperin,vitamin C,etc. And the puritanical streak in the US wants us writhing in pain until we can die and go to hell for our use of pot, birth control,etc.
I use hydrocodone because for medical reasons I must turn to this drug when I have serious pain. I don't overuse it and I don't sell it to kids and by the way other folks who use it and are willing to admit it are also good, responsible citizens.
And also, pot gives me a headache. Nothing is perfect for all people all of the time.
When profit drives action, humans are allowed to suffer and die by the millions, if not billions.
We need to grow up as a species. We need to realize that we don't need to have a society of "animals", and all we need to achieve that is to value science and education.
Dump religion. Superstition feeds into instinctual impulses which are part of our animalistic origins, but we have the ability to override that with will, but only if we don't encourage the distraction of instinct via superstition.
Dump money. It's based on a premise that resources are scarce, that we can't have things we want if we don't have something someone else wants. The premise of ownership of resources by a single person is unnatural and destructive and rooted in our ancestry, not in anything prescient to the current technological world we live in today.
If we lose the incentives to abuse by removing the desire to acquire (born of the illusion of limited resources and compounded by placing value on a person as a person by what they "own") we would solve 90% of ALL of our problems in an instant.
www [dot] thevenusproject [dot] com
I used to work for the Medicaid program and the number one drug was, you guessed it, Percocet, actually the generic, Endocet. The number two drug was, you guessed it, Vicodin. What will happen if they ban both these drugs? Americans don't have health insurance and now they are required to be in pain because Big Pharma wants to make drug cocktails rather than just the opioids. The experts that are working on this problem don't live in the real world and you can bet they all have their stash if things go dry.
[...] This is just crazy talk. [...]