Share:
Add to Favorites   |  

FDA: Hey America, Stop Overdosing On Painkillers!

5274 views

Look, we know this recession is tough and all, but you've gotta lay off the NyQuil and Theraflu or the FDA will stuff them behind a counter, ok? Seriously, an advisory panel is meeting today, and already voted to reduce the maximum daily dose of Tylenol and other painkillers. They might even slap scary "black box" warnings on all over-the-counter painkillers to dissuade you acetaminophen addicts from overdosing.

The Food and Drug Administration's panel voted 21-16 to lower the current maximum dose of nonprescription acetaminophen, which is 4 grams, or eight pills per day. Taking more than that can cause potentially fatal liver damage.

Despite years of educational campaigns and other federal actions, acetaminophen is the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA.

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

The FDA says patients often pair them with a pure acetaminophen medication, like Tylenol, exposing themselves to unsafe levels of the drug.

Drug makers Wyeth and Johnson & Johnson are rushing to defend your right to take the edge off life, but the FDA is still likely to follow the advisory panel's recommendations. Next time your head starts to hurt, pour a nice big glass of water, and resist the urge to pop a few happy pills. Your liver will thank you.

FDA panel recommends smaller doses of painkillers [AP]
FDA may put restrictions on Tylenol [AP]
(Photo: inhisgrace)

Post a comment

Comments:

89
user-pic

The real NyQuil is already behind the counters, at least in Florida.


They say it's because people use it to make Meth.

user-pic

@You know what ole' Jack Burton always says: The meth addicts have ruined it for us all. I love nothing more when I have a screaming sinus headache, yet must wait in the pharmacy line in order to provide my driver's license, other personal information, and signature just to get meds.

user-pic

Or just take an ibuprofen...

user-pic

I really wish the FDA would make available the relevant research when they post stories like this. I mean, how nebulous is the statement "can cause potentially fatal liver damage"? Is it a 2 to 1 chance, or did they find one rat in 100,000 that had liver problems after taking too much?

user-pic

If I'm unable to take my migraine happy pills, the alternative is sequestering myself to a dark, quiet place for 12-36 hours while my pain centers pound my brain into submission.


Otherwise, I'm cool with this.

user-pic

How is it the drug manufacturer's fault if, even after putting the ingredients and several warnings on the label, people continue to abuse it?

Have they asked people whether they take acetaminophen with NyQuil because they don't read the label and were unaware it was already present or because people believe that "some medicine is good, so more must be better"?

Didn't Tylenol run a series of commercials asking the public not to use its products if people were not going to follow the dosing directions?

user-pic

How many overdoses/liver failures/heart attacks etc. from Mary Jane? Exactly 0.

user-pic

@JeffIowa:

How many fatal car crashes? Probably thousands.

user-pic

This isn't all painkillers, though, it's just those involving acetominophen. Ibuprofen, naproxen, prescription stuff (that's unmixed with acetominophen) isn't affected. They'll likely chew up your gut before they get to your liver, so you'll have signs earlier. (Speaking as a veteran.)

user-pic

@henwy: Really? I feel like it makes you a better driver.

user-pic

@deadandy: There was a study about a year or so ago that showed that taking the recommended dosage of Tylenol for as little as two weeks caused over a third of people to show early signs of liver damage.

They mention the study in this article (it says it was 33-44% of subjects).

[www.medicinenet.com]

I specifically remember this because within days of seeing that story, I was talking to my mom, who told me her doctor had told her to take the maximum daily dosage of Tylenol every day, indefinitely, for arthritis pain. I told her not to, obviously.

Interestingly, I recently had a doctor recommend the same thing to me for very little reason.

It's made me wonder if this is common practice among doctors--to prescribe long-term use of OTC painkillers for their cumulative effects.

user-pic

I'm definitely one of those people that OD on neproxin/motrin/etc etc. I see a limit of 6 and that's what I use for my dosage. I just can't handle pain!

user-pic

Is that the Burger King guy as a baby?

user-pic

Is that the Burger King guy as a baby?

user-pic

When combined with alcohol, Tylenol is even worse for your liver. Literally under 2 grams of acetaminophen (4 extra strength tylenol) combined with one or two drinks can cause liver damage.

Essentially, there are two main metabolic pathways in your liver that break down tylenol. The primary one is non-toxic but it becomes saturated around 4 grams. That causes the additional tylenol to go through the secondary pathway, which produces toxic byproducts.

The bad thing is, alcohol also uses the primary pathway, so as you drink it becomes saturated more quickly and more tylenol gets diverted to the secondary, toxic pathway.

user-pic

@henwy:

Sure, but if you go there, you'll have to pull alcohol into the picture. How many fatal car crashes from that stuff?

user-pic

@TinkishDelight: no study supports that assertion. In fact most studies show that stoned drivers are as bad as drunk drivers.

user-pic

@atashida: I stick with acetaminophen because I can never remember if ibuprofen is dangerous while pregnant or nursing. It's one of them -- just can't remember which when I'm in pain. And since I've been pregnant, nursing, or both for most of the last 9 years that's something I have to consider. But of course I'm not the person that the FDA is targeting since I rarely take ANYTHING. Again...it's because I'm almost always pregnant or nursing.

user-pic

@deadandy: Acetaminophen gets broken down by the liver. Most of it is metabolized into nontoxic products. However, one of the pathways results in an intermediate product that is toxic. Your liver has a small supply of glutathione, which is bound to the toxic product to make it nontoxic. If you take too much acetaminophen, your liver runs out of glutathione, and the toxic intermediate damages your liver.

You should also NEVER take acetaminophen before or after drinking alcohol. Alcohol also consumes your liver's supply of glutathione, which makes the acetaminophen you take far more damaging.

user-pic

You can have my happy pills when you pry them from my cold, dead-from-a-damaged-liver hands.

user-pic

@floraposte: And naproxen has been linked to 1st trimester miscarriages. Really, it's getting to the point where we will all be just sucking up the pain because we'd rather deal with that than the side effects.

user-pic

Nooooo! Not Nyquil! I inly use it about twice a year, but when I have a cold, one dose of Nyquill knocks me out for the better part of a day. It's FABULOUS.

user-pic

My liver has been bad and must be punished.

Seriously though, at one point years ago I was on fistfuls of prescribed meds and I knew, just KNEW, they were slowly killing me even though the doctors said they were to "help" me. Today, I avoid pills of any kind until absolutely necessary. Even if it means enduring a headache or two. I don't even take heartburn pills anymore. Half a glass of water with a half teaspoon of sodium bicarbonate (Baking soda) will instantly relieve heartburn and is much cheaper and less dangerous than packaged heartburn pills.

On the other hand, I eat whatever I want with complete disregard for health factors. Far too much beef, soda, fast food, chips, etc. But at least I know what's in those things, for better or worse.

user-pic

@deadandy: [headaches.about.com]

Sadly, it happens more often than you think. People think it's safe because it's sold OTC - but daily use can cause long-term kidney and liver damage - even if you don't OD.

user-pic

@cmdrsass:

Yeah, but the majority of people that smoke pot don't do it then go out and party on the town. They plan around staying home and "chillin" or hanging out. Not driving all over the place.

user-pic

Brett Favre circa mid-1990's thinks the FDA is way out of line here.

user-pic

Most medications are essentially poisons with beneficial side effects. As it happens, acetaminophen becomes a nasty liver-destroying poison at surprisingly small doses. My licensed-paramedic med-student partner won't have Tylenol in the house and takes a dim view of it as an extra ingredient in other meds... he took 2 patients on "last rides" after they killed their livers with tylenol. One was 17 at the time.

user-pic

@floraposte: Yep. They're also generally more effective than acetaminophen. I have to wonder if people are OD'ing on Tylenol because Tylenol just isn't a very good pain reliever, so they think they need to take more.

I pretty much support pulling all the OTC drugs that mix acetaminophen with other things off the shelves. You should only take a drug if you actually have specifically considered whether you need each one, not just because it's in the mix with something else. It's stupid that like 3/4 of the cold medications on the market have acetaminophen in them, because a lot of the time I find you don't need it. Why take something potentially toxic just because it's mixed with something else you want? Buy them separately and dose appropriately.

user-pic

@missi1226: I totally agree with you. I just don't understand how putting these items behind the counter is going to all of a sudden give people the common sense to read the dosage recommendations and not abuse it anyway once they get home.

user-pic

@deadandy: It's pretty common knowledge that too much acetaminophen causes these problems. That's partly why so many drugs (especially controlled ones) are paired with acetaminophen. People can't take a high dose of them, because that much acetaminophen would cause some nasty side effects.

user-pic

@cmdrsass: They're just more sedentary and hungrier.


In all seriousness though - I've known few people under that influence who would drive that way. Most people camp out on their living room floor and play tetris/Dr. Mario/Mario Kart/Anything with colors while listening to the dead.

user-pic

@ekzachtly: The amount they would need to render enough for meth should be enough of a red flag though.

user-pic

@GearheadGeek: "Most medications are essentially poisons with beneficial side effects." The same can be said of pretty much all chemical substances, ranging from water and oxygen to iron to the most toxic, nasty, chemo treatments.

As far as pain relievers go, APAP occupies a useful niche, although not one as necessary as most people think. It is non-addictive (unlike opioids) and has none of the gastric side-effects of NSAIDs. (ASA, Ibuprofen, Naproxen, etc.) Yes, taken in larger-than-the-label does over a long time, it can induce gradual hepatic failure, especially when combined with chronic alcohol consumption.

However, most APAP-induced deaths are due to suicide. Yes, it is surprisingly easy to kill yourself with it, and it is indeed a horrible way to go. (You feel few symptoms right away, it can't be treated after 12 hours or so, you then spend a couple of days with nothing obviously wrong with you, then you die from liver failure.) But this is not a reason to ban it from the house.

I do agree that it should not be used as an add-on to other meds. I buy only single-ingredient cold remedies because I also don't want to run the risk of OD-ing on something because I was too zonked to read the ingredient list.

user-pic

@You know what ole' Jack Burton always says: Really? Every pharmacy I go to has only the version without pseudoephedrine (which is what you make meth with).

user-pic

@yagisencho: For several years I relied heavily on Excedrin Migraine, until I finally got health coverage again and went to a neurologist who prescribed actual migraine meds. When I told him in our initial interview that I was taking about 5 ExMigraine at a shot, every time, usually 2-3 times per episode (because they'd last at least 2 days), he said I was lucky to still have a stomach, let alone a liver. Well, I'm paraphrasing, but the point is, there might be a less dangerous alternative for you, too. Good luck.

user-pic

@You know what ole' Jack Burton always says: are you thinking of Sudafed? Nyquil hasn't been made with pseudoephedrine for several years, meaning that it can't be used for methamphetamine production.

user-pic

Seriously, my dear US friends, cancel your health insurance and apply for a Taiwan VISA. Whenever you get anything worse than common flu (like, a toothache), just buy a ticket and fly to my home country Taiwan for treatment. The money you can save will easily pay for the ticket and the medical care quality will still be better than what you can get in US. For example our survival rate for liver transplant is even higher than US (bring your own donor, tho. Unlike mainland china we don't kill our citizens then sell their organs).

user-pic

@You know what ole' Jack Burton always says: It is. At least the amount someone would need to manufacture enough meth to be profitable is. That's why they keep the pseudophedrine products behind the counter. Theoretically it helps to prevent shoplifting and also makes it easier to control or keep track of how much someone is buying.

In reality, however, it probably doesn't do a thing to curb or prevent meth sales or use. It's more like the security theater at the airport.

user-pic

That's ok, I can still treat being sick with whiskey.

user-pic

@JeffIowa: Yeah, but its a shitty, shitty cold medication, so what's your point? Oh wait, you don't have one. kthxbai!

user-pic

That's why I always exhale my pot smoke in lil' Jimmy's face. Save him from the perils of over-the-counter drug addiction.

user-pic

@BZMedia: Sodium Bicarbonate may reduce the pain of heartburn, but if you have an actual condition like acid reflux, all you are doing is treating the symptoms while the acid reflux disease may be corroding your esophageal lining.

My sister had really bad 'heartburn' for years until she started taking the little purple pill. Her results were astounding. We joke about it because its just like the TV ad where the friendly black guy says something like "Stop the pain. Heal the damage." Her case was probably a textbook case for the purple pill, but she took it for the month, rapidly got better, and now she's problem-free in that regard. She could still use a career.

user-pic

@ludwigk: So is acetaminophen.

Both marijuana and acetaminophen have been shown to be effective for managing pain, though.

So what's your point?

user-pic

@ludwigk: I see reformulated NyQuil on the shelves without pseudoephedrine and I see NyQuil-D behind the counter with the delicious delicious amine.

user-pic

@BZMedia: Half a glass of water with a half teaspoon of sodium bicarbonate will instantly relieve YOUR heartburn. That doesn't work for everyone, and if someone is on a low-sodium diet it's really not an option.

user-pic

@JeffIowa: But think of all the poor order takers at pizza delivery places across the nation!

'Uh. . .yeah. I'd like to order. . .um. . .a pizza. With. . .um. . .toppings. Yeah, toppings!'

user-pic

Do people really not know that most cough medicine contains 500mg of acetaminophen per serving? I mean, do they just down pills and medicines without even checking the active ingredients?

user-pic

damn... 8 tylenol is a massive daily dose... I rarely take more than 1 pill even if I have a huge headache (2 for those really really bad headaches). Seriously... cut the drugs at that point and seek professional help, like say a doctor.

user-pic

@JeffIowa: Immediate heart attacks are zero. But weed is pretty bad for your lungs and can contribute to heart disease just like smoking cigs can.


So, my view is to treat them and tax them like cigs, alcohol, etc.