FDA panel recommends smaller doses of painkillers (Vicodin banned; Nyquil not banned)

Source: Associated Press

ADELPHI, Md. (AP) — Government experts say prescription drugs like Vicodin and Percocet that combine a popular painkiller with stronger narcotics should be eliminated because of their role in deadly overdoses.

A Food and Drug Administration panel on Tuesday voted 20-17 that prescription drugs that combine acetaminophen with other painkilling ingredients should be pulled off the market.

... The panel also voted 24-13 to limit the maximum single dose of the drug (acetaminophen) to 650 milligrams. The current single dose of Johnson & Johnson's Extra Strength Tylenol is 1,000 milligrams, or two tablets.

In a third vote, a majority of panelists said the 1,000-milligram dose should only be available by prescription.

However, panelists rejected a proposal to pull certain cold and cough medicines off the market because of their role in overdosing. The drugs in question, such as Procter & Gamble's NyQuil or Novartis' Theraflu, combine acetaminophen with other ingredients that treat cough and runny nose.

Read more: http://www.google.com/hostednews/ap/article/ALeqM5iAaMZR2NEacGDWrzy-QZLjoLO7wQD9956NAO0

And it's probably the worst thing you can take.

the fact that it's basically hiding in nearly every OTC cold remedy means
that people are routinely overdosing themselves, and acetaminophen
overdoses can definitely be deadly.

Tesha

That people who overdose on Percocet and other pain killers do not die from the Oxycodone they die from the Acetaminophen.

However, you can easily overdose on the Oxycodone by itself as well...

PB

I don't see the logic there. If you know that two extra strength worked for you before then you will just take more pills and possibly overdose that way instead. :shrug:

I almost never do it because I'm pill-phobic, but there have been times where I've had such a bad cold that I took an extra pill or took a 3 hour dose because I figure the government errs on the side of a weak dose anyway. I think people tend to think of their medication in terms of numbers of pills and not milligrams, so even if they take extra, they'll be taking the right amount instead of an overdose.

the directions are not guidelines. They arrive at those via a scrutinizing and long FDA approval process.

what you do is called self medicating.

lol. Doctors often tell patients to take a higher milligram amount than what you can buy over the counter. Please don't pretend otherwise. It's foolish.

The FDA tests for efficacy and safety. They don't test to see what dose causes damage, and then approve a much smaller dose just because it's safe.

Exact dosages are determined mathematically by the rate of metabolism, so that they know how many molecules will be in your system at any given time following ingestion.

Taking 1 extra pill is increasing your dose by 50%. That's an effing lot of increase. Furthermore, there is an overlap between the subsequent doses, so if you're overdosing for an extended period. And if you take a second 3-pill dose, you are way over the margins.

From the FDA:

Q. Are there risks from taking too much acetaminophen?

A: Yes, acetaminophen can cause serious liver damage if you take too much. It is very important to follow your doctor’s directions and the directions on the medicine label.

You may not notice the signs and symptoms of liver damage right away because they take time to appear. Or, you may mistake early symptoms of liver damage (for example, loss of appetite, nausea, and vomiting) for something else, like the flu. Liver damage can develop into liver failure or death over several days.

Acetaminophen is generally safe when taken as directed. To lower your risk of liver damage make sure you do the following:

Follow dosing directions and never take more than directed; even a small amount more than directed can cause liver damage.
Don’t take acetaminophen for more days than directed.

A regular adult dosage of acetaminophen should not exceed 1,000 mg and no more than 4,000 per day.

An extra pill is fine, an early dosage is fine.

But I can clearly see why people die. You cannot just follow the directions on the label and think you're going to be okay. You have got to know what is going in your body and know what the recommended dosages are. That's the only way you can make sure you aren't compiling medication on top of one another.

The most common example? Doctors routinely prescribe taking 4 OTC ibuprofen to equal 1 prescription strength pill.

since you can practically inhale the bottle without any damaging effects(please do not take literally). I've never heard anyone say that about tylenol.

I said I sometimes take an extra one or take the next dose early, of freaking Tylenol. That would still put me at an amount equal to what doctors prescribe for Norco for example, where they do routinely prescribe dosages that include more than 700 mg of acetaminophen. I really can't figure out why anybody would argue this.

You're looking at permanent liver damage if you get anywhere near practically inhaling the bottle.

That being said, the regular over the counter dose is 1/4 that of the regular prescription dose. Ibuprofen has a bigger padding between the per-pill strength and the maximum daily dosage than Tylenol, but it's just as dangerous.

I've tried several other painkillers, they were never as effective as Vicodin for me personally. It's so frustrating when idiots who can't read labels ruin it for the rest of us.x(

That's why Tylenol is in all of those painkillers in the first place... to limit the amount that people take.

It's amazing how difficult it is to legitimately get painkillers, especially if you need them for more than a couple of weeks. Most doctors assume you're a junkie.

you just end up with someone strung out AND with liver damage. The thinking that that would stop abuse is simply crazy.

That's what happened to an ex of mine who was hooked on Lortab.

Sorry about your dilemma. Hope you find something that works for you if they pull this stuff.

Expensive (not covered by insurance), hurts like hell, but works if you follow the rehab to the letter. That and several years of chiropractic.

lots of ibuprofen, the Prolotherapy has helped me be able to walk almost like a normal human being. The docs had recommended ankle fusion or a STAR ankle replacement, but I didn't want to go under the knife and tried the Prolotherapy first. Two years later I am glad I did.

Incidentally, when I told a good friend, who is an M.D., about the Prolotherapy, his response was "that guy's a quack".

Sorry, didn't mean to hijack the thread.

Hydrocodone sure works great for pain relief, but I had some of the WEIRDEST dreams when I took it.

It completely fixed my lower-mid back with 7 treatments and about 3 months of the horrifying pain that goes along with the rehab exercises.

The doctor who fixed my back literally wrote the book on Prolotherapy and was pretty much responsible for refining it and bringing it back into usage in the early 90's. He was the father of one of a close friend. Unfortunately, Dr Dorman passed away a few months back. Even more unfortunate is that his clinic closed.

I honestly thought he was a quack at first too, but my wife insisted I go see him. One of the greatest men I've ever met. Had a few short political discussions with him as well, one within the first few minutes of the initial interview :)

A great obituary on Dr Dorman:
http://www.thenewamerican.com/culture/biography/917

For anyone who wants to find a Dr that does Prolotherapy...
http://dormanpub.com/reFrame.asp?page=/doctors/

while being myopic in his world view.

I've known a number of m.d.'s who were John Birchers. As the obit says, he was opposed to any form of government regulation and believed in free market economics. Not exactly a political progressive.

Back to prolotherapy, the Osteopath who is administering mine (less and less frequently due to my improvement) says that he has used it successfully on knees, shoulders, and hips, but my ankle was the first one he had done.

as well as giving you the option of doing the injections while knocked out, which I thought was amazing as he's mixing the more natural cures such as Prolotherapy with modern medicine. That came from his practicing modern medicine for several years before delving into Prolotherapy. In fact, the revisions that he made to the procedure and formulation pretty much brought it up to the standards of modern medicine.

It's amazing that insurance considers it "experimental" treatment, when it's something that's used widely in Europe, has been used here for decades, and has an amazingly high success rate. Just goes to show you how the insurance and drug companies don't want a cure. They want a lifelong treatment.

As for the political side, I think many of his views were well justified. Right now the DEA is breathing down the backs of doctors in their war on drugs, ready to pull the license of anyone who they deem as crossing the line. He went so far as to not accept any third party insurance, as he was pretty much against the practices of all insurance companies equally. Note that even medicare considers Prolotherapy an experimental treatment.

Basically, as his articles show, he was aiming at the same end result that we are. The views on humanitarian issues, government's current overreaching in many areas, etc are the same. The difference lies in the amount of government involvement in our lives.

Reading through his articles here:
http://www.dormanpub.com/index.htm
I agree with pretty much every end result that he's aiming for. It's the method of implementing that end result that differs. For example, in his article about how insane our patent laws are, he lists his ideals as a libertarian:
The basis for the success of Western civilization was the Industrial Revolution, and the principles of
1) individual responsibility,
2) mutual and collective benefit through...
3) trade and exchange, and
4) prideful enterprise and dedication to trade and profession (labeled by Calvinists a calling).

I agree with all of those points. Honestly, those were the principals that our country was founded on. The social safety net (which I believe is a necessity) didn't come in until the 1900's. The problems with the above mentioned principals is that when you throw corporations into the mix, or people who do not abide by those principals, you need a social safety net. It is also why government regulation of corporations are necessary. Also note that progressives do believe in free trade, however it must be well regulated in order to ensure truly free trade... unlike the crap we have now that we call free trade.

On a whole, I find myself having far more meaningful conversations with Libertarians than I do with Republicans, as at least some of the principals fall in line with Progressive views.

Vicodin after a couple of years wasnt effective in treating the pain, and since none of the three doctors I had seen would proscribe anything stronger due to the FDA's restrictive policies I just gave up and deal with it.

My condition (RSD)is treated in major chronic pain clinics in the south east with Percocet, but here in California thats not allowed for long term pain treatment.

So......I do without.

other is more generalized. Hence, one theoretically needs a smaller dose of each which generally works. This is a horrible what has just occurred.

who suffer from severe chronic pain and can't take other forms of medication for various reasons. I really hope something more rational is worked out here.

The Tylenol was added to prevent abuse. The doc may tell you that the Tylenol is in it because it works with the opioid for better pain relief, but it's really just there to deter people from overdosing/drug-seeking.

If you question this and currently take Vicodin, Percocet, or a different opioid+tylenol drug, try asking him for one without Tylenol in it. See how far you get :)

Just curious as it seems that they're making one legal while making the other illegal. Frankly, I doubtful about them being able to get rid of Vicodin. Too many people, like you, rely on it and it's just way too popular.

Really depends on what type of pain you have. But when it works, it works extremely well. And if they would actually legalize it, they could put it in a form that would not be harmful to the lungs for patients who don't have the money to spend on a vaporizer. Did I mention it's impossible to overdose on Marijuana?

i also take methadone for chronic pain.

Vicodin was about the only painkiller I could take.

Straight Oxycodone.

and that has tylenol.

There are plenty of alternatives.

people who suffer severe gastric distress from aspirin/etc.

Yes, most of us should probably avoid acetaminophen most of the time,
but it's very useful for some people.

Tesha

and was told by my physician to take tylenol instead of motrin, as tylenol is easier on the digestive system. however, the drawback is that it's bad for your liver too.

and after I had been taking 800mg tabs of motrin for a couple years, they put me on tylenol which was much less effective.
My shoulder pain is from a trapped nerve in my stomach, not from busitis or tendonitis as they originally diagnosed. It took me four years and a trip to Johns Hopkins to learn this.
I've been taking Tylenol 3 when the pain gets bad but hate to do it because of the constipation, which is almost just as bad.

I pointed out the difference in the tylenol dosage to my doctor. He was like... "Huh?" One pill of Vicodin had 500mg tylenol and 5 mg of codeine, and the tylenol 3 has 300mg of tylenol and 30 mg of codeine. So I can take 1/4 to 1/2 of the tylenol 3 and get more pain relief and less tylenol than by taking a whole vicodin. He had wanted to give me vicodin because the codeine was less.

But now I suppose they are taking it all off the market?
Good god. What am I supposed to do now?
Those of us with real chronic pain that the insurance companies will not let us get fixed (they'd rather sell us pain pills forever) have such a hard time. Some nights I just lie in bed and cry from the pain.
These days I drink my meals and eat extremely light.
I hate taking any pills, but if I didn't my quality of life would be in the toilet.
Wait... it already is.

Hydrocodone (what's in Vicodin) is far stronger than Codeine (what's in Tylenol 3), and a completely different chemical makeup.

The 5mg of Hydrocodone in Vicodin is more comparable to something like 15-30mg of Codeine (there's no exact comparison since they're different chemicals).

However, it boils down to which one works best for you. Different chemicals equals different effects, and everyone's body reacts differently to medication.

...the dosages in products. The problem is that it is in so many different
medications that it's too easy to combine, say, an OTC cold medication
with an OTC allergy medicine with a couple of Extra Strength Tylenol
and find that you're way over-dosed on acetaminophen.

So they're trying to discourage "bundling it" it so many things. The
two opiate drugs will still be available as well, even if the acetaminophen
is forced out of them.

Tesha

They (opiates) do have certain drawbacks. There are other NSAIDs too.

I suppose what I think is that anyone that considers using Tylenol ought to be warned in the clearest possible way about the "side-effects".

I will never understand the utter lack of compassion. There are numerous cancer patients, serial spine surgery patients, and patients with especially severe forms of other chronic illnesses that must take prescription medications to alleviate pain or else the pain level is intolerable. Visit a hospice for some understanding of this. The FDA's flip decision in this case is a radical example of their puritanical impulses rather than a reasoned response to a legitimate medical problem.

people from taking more than the prescribed dose. As I said in a previous post, if you doubt that's the reason Tylenol is in these drugs, try asking your doc for straight Oxycontin instead of Percocet. I had several discussions with my various docs on this topic, because it's in blatant disregard for the safety of the patient, given that Tylenol is such a dangerous drug.

Wanna see my stomach bleed???

Acetaminophen is my only over-the-counter pain med, and it's very useful to me.

They're removing it from being combined with those that contain opioids...

The majority of people won't ever look at what's in the medications that they're prescribed and how they work, and overdose because they aren't paying attention to the fact that there is Acetaminophen in Vicodin.

There's plenty of uses for both Acetaminophen and Vicodin, but they have no place being in the same pill.

so what would suggest we try over the counter for pain?

I get migraines, but because of my Crohn's, the only OTC med I can use is Tylenol. Which doesn't even work all that well, but it's been my only choice. (Can't take the Rx migraine meds as often as would be needed, either).

I'd love to be able to use Advil again. It works much better for all sorts of pain. But it's off-limits.

Nobody is taking Tylenol off the market here, they are just taking it out of opioid-tylenol combinations.

I was a bit overboard there. There are people that tylenol is a solution for, but they need to be aware of its toxic effects. If you have liver troubles, Tylenol should be avoided.

As already posted, it is too already difficult to get pain meds for legit use. There are state laws too but in general docs who prescribe, no matter how carefully, get persecuted by feds (DEA for example). I suggest that alcohol + Tylenol is more dangerous than hydrocodone + tylenol. Yet Nyquil is OK and HC is not? In any case this decision is more "anti-drug" then safety. It appears to be part of the larger conservative (OK, I really mean ignorant) movement which jails people for marijuana, etc etc.

I simply can't believe that a small group of experts could make such a cruel, unreflective decision that will condemn people with major illnesses to endless suffering or to finding drugs in illegal ways.

Doctors who are reluctant to prescribe pain meds other than the poisoned ones are committing malpractice of the worst sort.

Sue them and yank their medical licenses.

There are numerous websites dedicated to advocacy and awareness for chronic pain patients. Do some research. If tylenol makes these drugs "poisoned" then why isn't it being banned?

Many doctors are afraid to prescribe "stronger" meds than vicodin. The DEA is watching...

Patients end up getting too much acetaminophen and not enough of the stronger, more appropriate meds. If they are drinking more alcohol than they let their doctor know about, or taking more vicodin -- mind you not because they are drug addicts, but because they HURT -- then they trash their livers, and there is no reason for it. They'd have been just fine if their doctor had the guts to write prescriptions for honest pain medicines. Instead they end up about as sick as a person can get, and then they die.

Even worse, when Vicodin gets out on the streets it ends up destroying the livers of people who ARE abusing drugs and alcohol.

The "war on drugs" is killing the people it is supposed to be helping because doctors are afraid to prescribe appropriate meds and stupid dishonest formulations like Vicodin are substituted. Certainly acetaminophen and opiates are effective in combination, but combining them in a single tablet KILLS people. It would be far less deadly to prescribe the meds separately. Take this pill, and that pill. Yeah, sure, the addicts are only going to take the pill that gives them the buzz, not the acetaminophen, but they don't deserve to have their livers destroyed under any circumstance.

You might want to do some research yourself. I know too much about this shit. I can't even listen to the news about some celebrity with a ruined liver and first think Vicodin did it.

Drugs like vicodin needs to be discontinued, and doctors need to be up-to-date about modern pain management or get out of the business.

The puritanical pain cultists and DEA nannies can go fuck themselves with a cholla cactus. They kill people.

I am just worried that this is the beginning of a series of similar moves by the FDA regarding pain medications because of all the negative press re: celebrity abuse of these drugs. People with real illnesses must have them and the hoops patients have to jump through for treatment are just insane. As you put it, the "puritanical pain cultists" are trying as hard as they can to make life miserable for legitimate patients.

I get so angry.

:grr:

When are we going to start treating drug addiction as a medical problem? When are we going to let doctors treat pain patients with appropriate medications that work very well with minimal side effects?

What kind of monster denies a little old lady with crumbling vertebrae or a cancer patient appropriate medications because somewhere someone might be abusing those medications, or God Forbid, that little old lady or the cancer patient might be feeling a little high? Of course they're feeling high when they are on drugs... the pain isn't beating the life out of them!

Legitimate patients are routinely denied medications for the very reasons you mention. It is just appalling that physicians refuse to help the most vulnerable and helpless members of our society.

I took it after extensive abdominal surgeries. The healing time lasted a long time and even after I had stopped taking it with any regularity I would have occasional pain I just could not control with Tylenol alone. My surgeon thought I could be addicted. I responded that I had never been addicted to painkillers before or even nicotine (I stopped smoking w/no side effects after 20 years of smoking). When I no longer had pain, I no longer wanted vicodin. I ended up with leftover pills to find a way of disposing of safely...

Vicodin is extremely addictive, which is why I think it should be closely monitored. However, the monitoring should be done by a doctor and his patient, not a doctor and the DEA.

Months later I talked with an esteemed anesthesiologist from Mass General hospital who had some fascinating insights into pain management. He had a pain management specialist on his staff and he said my surgeon's thinking was old school, that lots of new information in the field had been discovered. So I think it is possible that people like me are not so "few" (I come from a family with lots of alcoholics and smokers, altho my mother and father were addicted to neither even tho both of them at one time had smoked and quit with no adverse side effects). Why was my brother an alcoholic and an addicted smoker (one of the major causes of his death at 66) and I am not? I don't feel I have any more "will power" than he did. It's so sad, really...

Able to give up something and not look back. Others in my family, not so much. I have to say though, the physical withdrawal from Percocet is a nasty nasty thing. That does take willpower to get through. Honestly, the thing I had the most trouble getting off of was anti-depressants. For several months after, even after tapering doses down to the lowest dose once every few days, if I would go further I got horrible dizziness and disorientation. I had to take Xanax to get off of it...

stone was pressing out my breath. It was at a time when the pressures of my job and my being responsible for my mother's transition to assisted living and my disabled brother to a nursing home that I was so anxious. The xanax worked. When the stress diminished, I needed no more xanax. It was as if it never happened...

It sounds like you had a very hard time, health wise. Maybe my relative good health throughout my life is the reason for my not being addictive. My experiences, thank god, have been temporary and relatively short lived...

I'm on proper ADD medication now as of a year or so ago, which I found out I should have been on since I was like 8 years old (would have saved me a lot of trouble in many areas, but my parents were against medication for it). Incidentally, being on the ADD medication pretty much got rid of my anxiety issues. I was diagnosed with Celiac's disease and a few other gut-related issues about 2 years ago. Had to self-diagnose myself and bring it up to my doc to do the test. For some reason the previous docs didn't do the blood work for it.

All in all, I'm doing pretty well now. I take the ADD medication, 1/2 of the lowest dose of Xanax a couple times a day for my gut issues, along with Hyomax (also for my gut issues).

I went from not being able to eat ANYTHING with more than a tiny amount of oils in it to being able to eat for the most part what I want (aside from gluten). That's where the Xanax/Hyomax combo comes in. Slows down the gut reaction from the oils and lets me actually digest the food.

As for my back problems, they're to the point where I can do a fair amount of outdoor manual labor and things like walking with my son on my shoulders without paying too harsh of a price for it, and without painkillers.

healing and relief from constant pain. It is not fair to you.

Whenever I hear of problems people have I realize that the world is full of pain and suffering. I am humbled by the experiences that you have had to endured. I wish you the very best in your life for you and your family....

Take care, dear merwin...

I spent yesterday trying to get my dad to go to the doctor to get tests because he most likely had a mini-stroke a couple days ago. Ended up getting him to go with help from his caretakers, my brother (an ER doc), and the threat of putting him in an ambulance if he didn't go voluntarily. He's got late-stage Parkinson's. Compared to him I'm the picture of health.

Days like that help put things in perspective.

Does this mean Vicoden in all forms would be pulled, or would it be reformulated to omit the Tylenol? There are people with real pain that need these medications.

relatives who need their medications or else we fear that their health will decline dramatically, as has been proven in many studies.

Bring beer!

edit...(Or whatever you got. I'm easy.)

gas. The only high I can really enjoy.

kind of uncaring. Besides having a very low threshhold of pain I also am terrified of the dentist hitting a nerve, which happened to me once and I was so shocked I burst into tears right there in the dentist chair.

The acetaminophen was put in opiate painkillers to "discourage" abuse. They might have used any other poison... maybe colloidial silver, so we'd recognize drug users by their blue skin. But instead we destroy their livers.

Our attitude toward drug abuse in the U.S. is fucked up beyond all comprehension. In many ways we are still the insane puritanical society that burned witches.

There are medical conditions where strong pain relievers are the only option left, and it's pretty shitty that we deny people adequate pain relief because some other person has abused these drugs.

Drug abuse by itself is a medical problem, and some people are more prone to it than others. I don't abuse drugs but I'm not claiming any sort of moral superiority for that because I've never found them especially interesting. This has everything to do with my personal biochemistry and very little to do with my "good character."

Consider the ramifications if The Tylenol Scare was actually a cover up for an error in the manufacturing process that provided too much acetominophen which subsequently killed people.

Would the cover up of this event by claiming tampering with Cyanide, which of course, was never resolved, save a company from complete destructive litigation and scrutiny? Would an event such as this allow a Company that discovered that it was selling poison over the counter to millions of Americans to clear the shelves of all the tainted product and allow them to destroy it without the authorities ever taking a look at the actual formulation?


Beleive it or not, but this type of behavior has happened in the L-Tryptophan contamination, when the Japanese actually destroyed the Genetically Modified Organisms they were using to produce the tainted L-Tryptophan. Nobody was able to test the bacteria prior to the supposed destruction of the GMO, so there has always been a question regarding the exact method of the contamination.

Corporations are not beyond these heinous tricks, and I hope people will open their minds to the possibilities of the lengths that Corporate leadership will go to protect their profits.

I worry about the damage but the doc keeps telling me I'm ok

I have chronic kidney stones and almost no doctor will give me vicodin or percocet. If I ask for it, they think I'm a junkie. All I have left to do is smoke pot, which helps, but it is illegal.

What a stupid f'd up country I live in.

Tylenol. I completely feel for you, being on Percocet for around 2 years after a motorcycle accident... at which point they didn't want to give me any more and instead wanted to put me on Tramadol, which flat out didn't work.

The DEA needs to take a few steps back from the situation and let doctors do their jobs. The reality is that the docs are scared to get their licenses pulled, so they won't prescribe medications that some patients really need.

It's a very addictive drug. I've seem my fair share of well meaning people get really really hooked on it. I stopped taking it when I got to the point where I felt I was using it as a crutch more than anything else. Unfortunately, that ended up in me having severe back pain again. I was able to actually enjoy activities such as skiing while taking Percocet. Even after Prolotherapy, which resolved the majority of my back issues after my motorcycle accident, I still cannot fathom going up on the mountain and making it more than an hour of skiing before being completely destroyed. I haven't gone up since being off of Percocet (3 years).

I do agree that people should research what they take. I always do, as second nature now... but not everyone knows how to look up drug info and actually understand what it means when get the info.

It's not that people are brain dead, they just are uneducated, ignorant, and blindly take the advice of their doc.

That's the worst. Aspirin does as well in double-blinds, IIRC. And they load it up w/ the 650 acetaminophen. I've taken two and they don't do near as much good as 2 Advils. But that's 1300 on your way to the 4000 max. My bottle said 4 a day. Take 7--cause the pain is still there--and you may die.

They'll only go for the ibuprofen or asprin based meds if there's a good reason, like an allergy.

Asprin is overall less safe than Tylenol in terms of side effects.

I have back problems and darvocet always works for me. I tried vicodin for it and didn't like it at all.

acetaminophen has never done a thing for me, pain-reliefwise.

most people, and even some dr.s and dentists have no idea that it even exists.

I'm prescried Vicoden for pain associated with immune boosters, and it cuts like a scythe through the hurt.
For anything else? I'll leave the tylonol and motrin on the shelf.....nice big pipe for me, no headache, cramp, gas pain, ache, soreness, etc etc that I havn't been able to flush right the hell out with a dose of mothers meds. :)