FDA panel to vote on painkiller restrictions (outlawing Nyquil, Theraflu)

Source: Associated Press

Government experts are scheduled to vote on whether Nyquil and other combination cold medications should be pulled from the market to help curb deadly overdoses.

The Food and Drug Administration has assembled more than 35 experts for a two-day meeting to discuss and vote on ways to prevent overdose with acetaminophen — the pain-relieving, fever-reducing ingredient in Tylenol and dozens of other prescription and over-the-counter medications.

Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA. There are about 200 acetaminophen-related deaths each year.

... The drugs that could be pulled off shelves are combination medications, such as Procter & Gamble's NyQuil or Novartis' Theraflu, which mix acetaminophen with other ingredients that treat cough and runny nose.

The FDA is not required to follow the advice of its panels, though it usually does. The panel vote is scheduled for Tuesday afternoon.

Read more: http://www.sfgate.com/cgi-bin/article.cgi?f=/n/a/2009/06/29/national/w052944D68.DTL&tsp=1

into a Target frozen food distribution. have no clue why. FDA regulation. Now this idiotic discussion. Regular cough syrup doesn't do anything. ... neither does Nyquil. It's only benefit. putting one to sleep. When your sick it's difficult to go to sleep. Abuse it? EWE!!!!!!

and cause 23 cases of liver damage. o_O

But seriously.... how many cases of liver damage is caused by people who abuse beer? Shall we ban beer and uh mikes hard lemonade? (grew up on citrus drinks can't stand beer, but hard citrus drinks , slurp)

Do you support prohibiting alcohol again?

If not, why not?

Teach everybody how to read a dosage and warning label.

As I recall, the dosage regarded as safe used to be in the 5000 mg range, but it has steadily been lowered over the years as more people end up with a damaged Liver.

Considering that Acetiminophen is in many different medications, it is frighteningly easy to exceed a toxic dosage.

Considering that vicodin, the most widely abused prescription medicine in the world, can have up to 750mg of Acetominpohen per tablet..

Your most likely better off taking pure morphine sulphate for pain and avoiding the Liver trauma.

And I've asked my doctor to give me less of the Acetiminophen in my meds and slightly more of the hydrocodone but she's afraid of the addiction factor for me. Hmmm, addicted or dead of liver failure. Which would I rather be?

If you have something chronic, specialized PM doctors are generally a lot better with managing pain medications, and they understand the difference between addiction and dependence. I've done well with mine.

... Should you already be with a pain management doctor, then I'm out of ideas. :P

But hey. I'm in a big club so that's something.

I also have a very rare condition, and my PM doctor happens to be one of the few who knows how to treat my pain. He tries to keep my visits to a minimum so as to reduce costs, and he's understanding when I can't afford procedures. That's pretty often, since my condition disables me and I lean on my folks a great deal for help.

So, in a way, I know the boat you're in. :hug:

Vicodin: 5 mg hydrocodone, 500 mg acetominophen (or 10/750). Norco: 20 mg hydrocodone, 375 mg acetominophen. I'm very happy with the change. Acetominophen scares the hell out of me-- I have some liver issues anyway, and I HATE taking the stuff.

I had her start giving me 5/350's instead of my 5/500's but the cost difference was ridiculous. It cost twice as much for a pill with less medicine so I had to go back to the other out of financial necessity. I can't be given Ibuprophen based pain killers apparently due to the blood thinners I'm on. So I'm stuck in limbo with my liver in danger.

Ibuprofen isn't perfect but causes fewer problems than Tylenol.

David

for the sale of products, we must outlaw the sale of alcohol, tobacco and cocaine (oh wait, we already did that).

All of the killer drugs they fast-tracked through during the BushCo. years and they're worried about NyQuil?

Talk about fucked-up priorities.... :eyes:


Apparently the foxes are still in charge of the hen-house over at FDA.

Money must have gone for cocktail parties

That's how I learned to fear acetominophen. Frankly, I think the proposed FDA action is a good one. Acetominophen is DANGEROUS stuff. The mere fact that this thread is generating such outrage is testament to the degree that lots of people don't understand that. You only get one liver!

is the FDA in the pocket of corporate interests, or do you want them doing something to protect consumers.

The maximum dosage of Tylenol is very close to its toxic dose -- especially if alcohol is involved. Same with NSAIDS and stomach bleeds. These aren't mild side effects. 50,000 ER visits a year, 25,000 hospitalizations, and they should do nothing?

http://blogs.wsj.com/health/2009/06/29/acetaminophen-worries-the-end-of-nyquil-as-we-know-it/

It's the acetaminophen that is toxic to the liver... It's dangerous to mix it with alcohol, HIV medications, or other meds metabolized by the liver (e.g. antidepressants) OR take it while suffering from some sort of liver ailment.

Additionally, accidental or purposeful overdoses are difficult to reverse because an acetaminophen overdose can destroy the liver.

Replace acetaminophen with ibuprofen (Advil) and the liver toxicity risks are greatly reduced.

And... The average consumer does not know this... I have many friends that take Tylenol for hangovers, which seems like the worst thing I could imagine to take.

Also, I suspect Nyquil and Theraflu fans like antihistamine and decongestant ingredients most and wouldn't care if the analgesic was Tylenol or Advil.

and with uniformed people actually taking Tylenol for a hangover! There are warnings on Tylenol about don't use with alcohol , but very small and don't stress the very real dangers enough in my opinion.

A real public health awareness campaign should be done about this.

"...But I might be inconvenienced!!" WTF.

Edited to add: How about this: if Johnson & Johnson and Wyeth are against this, how about we assume it might be a good thing?

removing or making these specific medicines harder to get really whats in the consumers best interest?
As someone pointed out there are far more deaths caused by drivers in cars every year but i don't see the government banning their usage or even considering it.
Also what will be the real impact to the consumers, will this cause prices to go higher on these products (assuming their not outright banned), will it cause a hardship for the poor and or elderly to purchase them if they need to?

To a great extent, I think the outrage expressed in this thread is a good indicator of the extent to which people don't understand just how dangerous acetominophen is.

A study in the Journal of the American Medical Association determined that it only takes 2 weeks for healthy adults to sustain liver damage from acetaminophen. The study involved taking four grams of acetaminophen a day for only two weeks. Four grams is the maximum daily recommended dose. So if you're taking a recommended dose, you can damage your liver in only 2 weeks. How many people aren't aware of this? And how many sick people will take NyQuil, while also taking Tylenol, without calculating the total amount they're taking? Furthermore, 56,000 people seek emergency treatment annually, but how many people are walking around with liver damage that may come back to bite them in the future, and they don't even know it yet?

I see this as a public health issue pertaining to a potentially deadly product. At the very least, it shouldn't be mixed with other remedies. Nyquil (and other products) can be made without the added acetaminophen.

NyQuil when you're sick really, really, really helps.

The pisser is that drug labels often understate the proper dosage.

The double pisser is that doctors will sometimes prescribe a HEAVY dose.

And the triple pisser is that people assume that OTC meds are safe. :banghead:

I don't buy NyQuil for its acetaminophen, its the Dextromethorphan that gives NyQuil its kick. It's just like Tylenol with Codeine, I swear they put it in there to dissuade people from abusing the active opiate ingredient, but they do anyways and wind up in far worse shape thanks to the unnecessary acetaminophen content.

Best fucking stuff there is when I'm sick!
That and DayQuill make me functional when im suck as a dog, and able to breathe!

I use it sparingly, and never mis drugs (I even stop taking allopurinol because im paranoid abotu mixing!)

I didn't know the exact effects of aceto... aspirin however. I knew it was a blood thinning agent but not that it caused liver damage.
I know that Ibuprofen does that - as a gout sufferer, i know a fair amount about the BAD effects of certain meds that I need.

Mmmmm where would I be without my cherry death and orange gel-tabs?

I hate theraflu but it also works a treat when i NEED to be able to breath.

But I understand their concern, and I'd be right mad if one of those 200 were a family member... but really the FLU kills more people, which, ironically, is why we TAKE Thera Flu and NyQuil!!!

I have not been sick or had a cold for 4 years straight.

I'd much rather be healthy all the time than rely on some medicine that is primarily alcohol.

is hepatotoxic. lots of effective drugs are.

and that's clearly spelled out on the label. and not in big words.

i went to a suicide last year where somebody purposefully swallowed a bottle of tylenol.

it's actually a pretty effective way to kill yourself. there are much easier ways. insulin is over the counter (at least in WA state) and far more effective, but still.

I keep meaning to buy a pack in the States but keep forgetting. Whenever I get a really bad cold or cough the Nyquil really clears it up. I haven't had Nyquil for nearly 3 years and have taken other meds to clear up my cold and cough but they are not as good as Nyquil.

I used to get insomnia at University and I took Nyquil to force me to go to bed early and the next day my sleeping patterns were readjusted. I don't usually do that but it did help readjust my sleeping schedule for the better.

also whenever i go home I get a couple bottles to bring home with me.

In the UK/Ireland they have something called Night Nurse, which I suppose is the same thing but under another name, you might want to look for that, if you dont have anyone to send it to you.

Otherwise I dont know :(

Sadly there doesn't seem to be a business online that sells this stuff to Expats - probably for legal reasons lol.

WTF I mean really - just cause some fuckin idiots can't be bothered to READ THE INGREDIENTS and warnings on a bottle means we ALL have to suffer? Is it too much to ask that someone GET INFOMRED on the drug they are about to put in their body? :eyes: Argh I am so sick of some "higher authority" telling me what I can and can not do when I am not hurting anyone. Fuck off indeed FDA!!! :banghead: :grr:

*edited to say - I definatly do support strong bold warning labels - just not outright banning.

the fact that many people choose to abuse clearly labeled medications should not mean that people who use them properly should be punished.

it's like the kindergarten teacher punishing the whole class for what little johnny did.

i knew somebody in college who abused the #($#( out of nyquil. deliberately.

as long as the dangers are clearly explained, and they ARE, caveat friggin' emptor.

What do they plan to do with Dayquil since it also has Tylenol in it??

As many as I can get my hands on

Guess I'll be going shopping although no sense to buy too much because it will expire. Maybe I can trade in that Zicam I paid $9.00 for and never used.

They would have a country full of zombies during cold & flu season, from lack of sleep, if they do that.

Once again it appears due to the stupidity of some people that don't follow directions, those of us that do will once again be regulated. I take two Tylenol arthritis most mornings due to the pain. They take care of it and although I could take more after eight hours I never do. Now they will attempt to take this away from me so I will have to get a Rx for something else? When will this "government" allow people to take responsibility for their actions? If I choose to abuse Tylenol and my liver goes bad, is this not my fault?

cigarettes, all medication, cleaning supplies, spray paint, glue.......... just about everything.

To make us have to go the the doctor more often.

There is an agenda behind everything significant that happens, what is often difficult is to discern the agenda and whose agenda it might be.