FDA Panel Sounds Alarm On Painkiller Doses

Experts Warn Of Overdoses On Tylenol, Other Painkillers With Acetaminophen; Say Vicodin, Percocet Should Be Eliminated

(CBS/AP)  Government experts called for sweeping safety restrictions Tuesday on the most widely used painkiller, including reducing the maximum dose of Tylenol and eliminating prescription drugs such as Vicodin and Percocet.

The Food and Drug Administration assembled 37 experts to recommend ways to reduce deadly overdoses with acetaminophen, which is the leading cause of liver failure in the U.S. and sends 56,000 people to the emergency room annually. About 200 die each year.

CBS News medical correspondent Dr. Jennifer Ashton said a lot of over-the-counter medications contain acetaminophen, and it can be hidden in the mix, which may contribute to overdoses when patients don't know they're getting a lot more than they think.

"We're here because there are inadvertent overdoses with this drug that are fatal and this is the one opportunity we have to do something that will have a big impact," said Dr. Judith Kramer of Duke University Medical Center.

Evelyn Byrne's daughter Madalyn, a college sophomore, died after taking eight Tylenol a day for a week, for tooth pain, reports CBS News correspondent Cordes.

"Had the dosages said four tablets a day instead of eight, she'd be alive today," Byrne told Cordes. "I have a hard time wrapping my mind around that."

But over-the-counter cold medicines - such as Nyquil and Theraflu - that combine other drugs with acetaminophen can stay on the market, the panel said, rejecting a proposal to take them off store shelves.

The FDA is not required to follow the advice of its panels, though it usually does. The agency gave no indication when it would act on the recommendations.

In a series of votes Tuesday, the panel recommended 21-16 to lower the maximum dose of over-the-counter acetaminophen from 4 grams, or eight pills of a medication such as Extra Strength Tylenol. They did not specify how much it should be lowered.

The panel also endorsed limiting the maximum single dose of the drug to 650 milligrams. That would be down from the 1,000-milligram dose, or two tablets of Extra Strength Tylenol.

So what is the advice of CBS News medical correspondent Dr. Jon LaPook?

Do the math.

"Tylenol comes in three doses: 325 milligrams, 500 milligrams, and 650 milligrams. The FDA says right now to limit your daily dose of acetaminophen to 4,000 milligrams. Now, 4,000 milligrams translates to 12 of the 325, to eight of the 500, and to six of the 650," LaPook said. "The bottom line is you have to keep track."

A majority of panelists also said the 1,000-milligram dose should only be available by prescription.

The industry group that represents Johnson & Johnson, Wyeth and other companies defended the current dosing that appears on over-the-counter products.

"I think it's a very useful dose and one that is needed for treating chronic pain, such as people with chronic osteoarthritis," said Linda Suydam, president of the Consumer Healthcare Products Association.

The experts narrowly ruled that prescription drugs that combine acetaminophen with other painkilling ingredients should be eliminated. They cited FDA data indicating that 60 percent of acetaminophen-related deaths are related to prescription products.

But some on the panel opposed a sweeping withdraw of products that are widely used to control severe, chronic pain. Prescription acetaminophen combination drugs were prescribed 200 million times last year, according to the FDA.

"To make this shift without very clear understanding of the implications on the management of pain would be a huge mistake," said Dr. Robert Kerns of Yale University.

If the drugs stay on the market, they should carry a black box warning, the most serious safety label available, the panel decided.

"If we don't eliminate the combination products we should at least lower the levels of acetaminophen contained in those medicines," said Sandra Kewder, FDA's deputy director for new drugs, summarizing the panel's vote.

Percocet and similar treatments combine acetaminophen with more powerful pain relieving narcotics, such as oxycodone.

"As doctors, we get used to writing a prescription for Percocet or Vicodin, we do have to write down the number of acetaminophen in that dosage," Ashton said on "The Early Show". "But a lot of times, we're just used to it as that brand name, and we might not realize just how much is in there."

If the combination products are eliminated, the acetaminophen and the other ingredients could be prescribed separately. In effect, patients would take two pills instead of one, and be more aware of the acetaminophen they are consuming.

Vicodin is marketed by Abbott Laboratories, while Percocet is marketed by Endo Pharmaceuticals. Both painkillers also are available in cheaper generic versions.

"The panel recommending banning Vicodin and Percocet seems a little draconian," said Les Funtleyder, an analyst for Miller Tabak & Co.

Drug companies avoided the most damaging potential outcome with the defeat of proposal to pull NyQuil and other over-the-counter cold and cough medicines that combine acetaminophen with other drugs.

These drugs can be dangerous when taken with Tylenol or other drugs containing acetaminophen, according to the FDA, but cause only 10 percent of acetaminophen-related deaths.

"I don't think we should be advocating a solution to a problem that really is not there," said Dr. Osemwota Omoigui, of the Los Angeles pain clinic.

A recall of combination cold medicines would have cost manufacturers hundreds of millions of dollars in revenue. Total sales of all acetaminophen drugs reached $2.6 billion last year, with 80 percent of the market comprised of over-the-counter products, according to IMS Health, a health care analysis firm.

"The acetaminophen people dodged a bullet," said Erik Gordon, a University of Michigan business professor who studies the biomedical industry.

Even with the lower daily dosage recommendation, consumers will likely keep taking as many pills as they think they need to ease their pain, Gordon said.

Analyst Steve Brozak of WBB Securities said the panel votes were a "shot across the bow" of the pharmaceutical industry.

"This basically puts more government oversight into something that heretofore has been less than present," Brozak said.

But is there an alternative to acetaminophen?

Ibuprofen, Ashton said, is a good alternative, but it's not without risk, either, because it could affect your kidneys and increase your risk of bleeding.

""If you're taking pain medication of any sort for more than a few days," she said, "you really want to do it with your doctor's supervision."

[jcole19471]

Finally, the FDA is protecting the interests of the American people instead of the drug industry.

[ibsteve2u]

And the CBS Evening News ran another prescription drug story tonight...prominently featuring a zoom of a Vicodin caplet.

Me, I am starting to wonder if I am not seeing a vested interest at work.

[Swabbie76]

Darling, you stated your liver, not your kidneys. LOL... Get your story straight. I know what organs are.. and you are playing one now.. its called "I'm Telling Stories, I'm telling stories". :)

[nancyrlewis]

Multiple organ failure means more than one organ fails - liver + kidney = more than one organ. Sometimes, both can fail at once. But you know what, while it's been a whole lot of fun to play with you - & while you've taught me a whole lot cf things - I think this is going to be my last post to you. I know, honey, it's tough. But I know I'll see lots more of your very informative & witty posts, so it won't be goodbye - thank God!

[Swabbie76]

Nancyrlewis - And how would Dialysis which cleans your kidneys help your liver? Again, your story does not ADD UP. You are talking to someone who KNOWS these medications and for you to have taken by your words "NOT THAT MUCH" more than what was prescribed.. You aparently have other problems. But to say that you took a couple percocet MORE than you should have and got acetaminophen poisioning - You are FOS (you know what that means). There is no doubt you have taken 2 Tylenol Extra Strength at some point in your life correct? Well, thats about the same amount you would have gotten taking TWO percocets ...which would have made you - WHO by the way is NOT use to taking these meds a blithering idiot... SO YES.. I CALL YOUR STORY BS...

Good Day Buttercup

[nancyrlewis]

Oh, Swabbie, Swabbie, Swabbie - Tylenol OD can cause multiple organ failure! And kidneys are organs! And when kidneys fail, you go on dialysis! See?

Hugs & kisses,

Your B.

[Swabbie76]

Wait a minute. I just read nancyrlewis's comment at the top. HOLD it. You want to BAN Percocet because you OD'd on it - because you thought it was only Tylenol? You said you only took A LITTLE TOO MUCH but yet had to be taken by ambulance, in the hospital 2 weeks - on dialysis. HMM.. hey buttercup.. you DO realize that you probably took a lethal dose of Oxycodone there? I am seriously doubting your story. For you to have had such an acetaminophen reaction the Oxycodone in the Percocet would have given you respiratory arrest. You DO realize there is ONLY 325mg of tylenol in an average Percocet right? You take 2 tylenol extra strength and thats 1000mg of tylenol. DO YOU SEE MY PROBLEM with your story? You would have had to eat 20 Percocets!!! I'm throwing the BS FLAG here. If you have something to add, by all means ADD it, but dont MAKE S*** UP! Hospital Tylenol is absolutely NO different than any other tylenol, its all the same. NOW - if you had told me you had BUFFERED the Percocets you were taking with a couple ES Tylenols for a few days.. yea.. MAYBE. But your story stinks so bad I can smell it all the way here in South Carolina.

[nancyrlewis]

Sorry, Swabbie-sweetie, but my story is true & your speculations are not. No one would have been more glad than I not to have gone through what I did, believe me. Because I can tell how concerned you are that I went through it (your sympathy is truly touching), I will tell you that I had had surgery on the other foot 2 weeks earlier & had taken Percoset as prescribed w/o problem for a day or 2. What my doctors said later (& I'm explaining this because you seem to be someone who is very concerned with truth) is that there probably was still acetaminophen in my system when I had the second surgery & that was what caused the overdose. The recent studies on this issue have revealed that most doctors don't have any idea what the safe limits on acetaminophen are - I know my podiatrist certainly did not. (I suppose you think it is irrelevant that I consulted with him before taking the increased amounts.)

Another thing the recent studies have revealed (again, since I know you are concerned with truth, you will be eager to learn this) is that previous beliefs about what are safe levels of acetaminophen are now being seriously questioned. I happen to be listening to NPR at the moment (I'm sure you are a regular listener of THAT network!) & their expert just said that deaths per year from acetaminophen (he may have said Tylenol - I don't recall) exceed deaths per year from all other medications combined. (If you know better, call in & tell them they're liars & you know better!)

About banning acetaminophen altogether, my own reaction may not be the most objective I will admit, but the vitriol, accusations & name calling my comments have apparently unleashed is astonishing to me. Guess some people have short fuses - or they're just unhappy, snarky & thoroughly unpleasant. Whatever. It's very odd since my motivation was really to let people know what happened to me so that they wouldn't make the same mistake. Until my comments here, everyone I spoke to was grateful for the information; many said they had taken more than the prescribed amounts of acetaminophen for years & were glad to know it was dangerous. I really hadn't anticipated being called stupid, lacking in judgment & sense, a liar, etc. However, if my comments here have informed at least one person that what they or someone close to them has been doing with regard to Tylenol & other OTC meds containing acetaminophen(& I really don't think taking too much Tylenol is uncommon), I will be very happy & taking the mud slinging will have been worth it millions of times over.

Your darling Buttercup

[bobnjersey]

[I happen to be listening to NPR at the moment (I'm sure you are a regular listener of THAT network!) & their expert just said that deaths per year from acetaminophen (he may have said Tylenol - I don't recall) exceed deaths per year from all other medications combined. (If you know better, call in & tell them they're liars & you know better!)]

this may be correct.

http://answers.google.com/answers/threadview?id=292523

http://www.aapcc.org/Annual%20Reports/02report/Annual%20Report%202002.pdf

[Meg003]

It says right on the Tylenol label, "may cause liver damage" if taken to excess and even cautions you not to take with other medications containing acetaminophen.

Because other people are careless or abusive, the rest of us cannot get good pain relief when we need it. And we blame the drug companies? Is anybody else out there offering scientifically tested medicines?

[glenaw-2009]

I have had chronic back pain and body spacticity, that has been getting worse, for the last 5 years. I'm now taking 8 tablets of Hydrocodone-APAP 10-325. This does not always take care of the pain. I have a bakloven pump inside me and they have started putting in morphine. Now with all that being said I can not imagine the pain I would be in if I could not take the vicodin.

I wonder what is motivating the FDA to do this. Any death is tragic but I question the move being based on 200 deaths. If it is strictly based on the deaths then why leave products on the shelves, still leaving it to the judgement of the consumer, while taking products off the pharmacy's shelves, which are controled by the pharmacy and the doctor.

It almost seems that someone didn't grease the palms enough.

[thinksmart55330]

What great news for people with severe pain. The FDA will ban the most commonly used form of pain killer, vicodin, because 200 people die a year. How do these people get to the positions of dictating what is right and wrong for others. Have a single one of them suffered from conitnued operations, continuing pain? I have had 7 sugeries on my left arm, I have a prothesis in both my wrist and elbow, transposed and damaged nerve and now they are recommending banning the very thing i use when the pain gets to me. So, what have they suggested as a replacement? What have they approved as a replacement? Nothing. What a surprise. I get so sick and tired of people who have not been in others shoes telling them what they can and can't take and can and can't do. Approve a replacement people before suggesting a outright BAN on something many people use to cope with pain.

[hologram5]

There is percocet without apap, I have received this for chronic pain BEFORE I lost my health insurance. Now I just use marijuana. Doesn't work as well but, without insurance, what am I to do?...

[Swabbie76]

Im sorry you lost your health insurance. At one point I did too, but at least I had the VA to fall back on. I hope you can find something that is better for your pain and body than MJ. Thats a deal with the devil right there, but you do what you have to - I understand. Have you investigated any of the prescription discount cards from Walgreens etc? When I was without HI for 2 months it helped alot. I was buying the generic Oxycontin at that time and it dropped the price to $87.00 for a one month supply. I would imagine that Apap 7.5 or 10mg would be MUCH less.

[Swabbie76]

For God's sake, talk to a doctor if you dont know if you should take it or not. Just because its on a store shelf does not mean its safe. If you Dr gives you bad advice - FIND ANOTHER. I have been seeing Pain Management doctors now for over 10 years. They ALL have worried about my intake of tylenol products while taking the Lortabs, percocets, Norco's etc. Personally? I think its nuts. Walk down the drug isle in ANY Store. From top to bottom, both sides of the Isle as far as you can see ~ Drugs. ER visits, deaths rise steadily from OD's on all this, people's lives shattered because of drug interactions one to another. Oh yea, they print all that on the cartons, but you have to know what MAO Inhibitors are and such. We are a society of PILL POPPERS. It did NOT use to be this way. I remember the days of my youth when I could carry an aspirin with me to school because I hadnt been feeling well in the morning - given to me by my Mom. It was no big deal. If a kid does that today he might get arrested.

Back to the article. The panelist who voted for the Vicodin/Percocet ban are just plain STUPID! There are MILLIONS of people who have Legitimate chronic pain that need those medications. NOW, either they will have to QUIT taking ANY.. OR.. the doctors will have to give them an alternative or STRONGER pain medications just because there are no lower strength equivalents available. Just plain stupid, absolutely moronic. This is a knee jerk reaction the same as earlier this year (January) one of this Dimwits brought it up to Ban Darvon/Darvocet too. Thats a great, NON-NARCOTIC pain med for people BEFORE they are presribed narcotics. I took it for almost a year .. I didnt want to get into the heavier stuff. These clowns have no idea what they are doing and how their decisions touch the REAL WORLD and REAL PEOPLE and affect REAL LIVES. Do I hate to see OD's from this stuff - yes. But people, EDUCATION is key.. however - remember one thing... YOU CANT FIX STUPID, AND PEOPLE ARE SOMETIMES VERY STUPID. They think if they take just a "little more" it wont hurt. Well - guess what Einstein - it DOES HURT. I'm being blunt because thats what people need to hear. I do not care if I offend anyone, big deal. I've offended plenty of people in my life. I do not suffer Stupid people to continue to blabber on and on. My heartfelt sympathies do go out to those who've had serious complications when they've followed the rules... but thats the way things go sometimes.

[danielleone]

also how many of the 400 deaths from tylenol were from sucide? it is an otc drug so easy to get.

[danielleone]

i have several chronic pain conditions, my oh so smart dr. told me to take Tylenol amd advil for years which helped at first, but now they don't help. i have been having severe stomache pains for over a year my dr. ignored my complaints now i have a ucler and liver problems which i will have to live with forever along with my other conditions. all because my dr. was scared to give me a pain medication because of the laws. i don't think it is right i have to live in constant pain everyday, like so many other people do. i got my dr to give me pain med. for 1 month to try to see if it worked i went from taking 6 tylenol and 3200mg of advil which was what i was told to take by my dr. to taking 3 perocet 5/325mg a day some days less then 3 pills were need. and it helped my pain.

[credibility2]

When is this government intervention trash going to end? Why are there so many morons walking the streets who don't read labels and refuse to take any personal responsibility for their own actions? If a person takes more than the prescribed dose of any medication, whether that's OTC or prescribed, then it's their own fault if something happens to them. This isn't a case of government trying to protect the public, it's a case of government hand holding and controlling the stupid masses. Not related to this medication, but related to how stupid some people are: eating raw cooking dough and gosh, getting sick from it; or, buying hot coffee from a fast food restaurant and putting the cup between the legs and gosh, oops getting burned. Stupid, stupid, stupid!

[woeisme1]

I agree that people in general are pretty stupid these days. Just look at the posts from the majority of republicans.

[Benton09]

Pharma companies and doctors....still the number one drug dealers in America, just from an office with a piece of paper on their wall instead of on a street corner or in an alley.

[nextgenman09]

These nuts at the FDA need to make up their mind. They say its AOK for Big Pharme to be TV drug pushers but say we're overdosed on OTCs!

What hoot!

[FrankDenise]

Do you know how many people are hooked on these type of narcotics???? I myself was hooked on Vicodin for years and I found a way to get them no matter what....This stupid government thinks it is going to control anything that is addictive and in high demand....If not opiates through pills,they will go on the street to cop heroin..Just like with weed people will find a way to get it...The bottom line is our country is probably the biggest users of drugs and alcohol in the entire world..And America had a hand in flooding its own streets with drugs as well...The war on Drugs...What a bunch of hypocrites...Drugs come into this cointry by so many different ways...Usually through those that are supposed to be keeping it out....What A Joke...

[justfacts2]

This comment is in response to nancyrlewis's comment. You want the FDA to ban something that you admitted to taking too much of in the first place? Why should they ban Tylenol because you were too stupid to take the recommended dose? It is because of people with your judgement that this is being brought up in the first place. If people would just basically use the brains they were given and use common sense, then there wouldn't be the health issues.

[nancyrlewis]

Are you that nice in real life, or just online?

[nancyrlewis]

By the way, while it pains me to take away your reasons for calling me stupid, lacking in judgment & common sense, etc., I will tell you that I checked with my podiatrist before taking the increased dose and he said it should be fine.

Wishing you all the pleasure your charm brings to others!

[megssister]

another thing to consider also is this, i am on coumadin (a blood thinner) and i cannot take ibuprofen or certain other meds due to its interaction. i can only take acetaminophen for pain and fevers, i have no other choice. its either another blood clot and severe pain possibly death or a pain med that can be monitored and controlled inother medications that people are not aware that it is in.

[megssister]

my sister (and possibly my brother previously) died from tylenol overdose. ironicaly she took it as prescribed which i know for a fact, and her tylenol blood levels were never monitored. this should be an absolute requirement. my sister was only 26 yrs old when she passed away last May and was in excruciating pain and those vicoden and other pain meds helped her get through the day. the answer is not to eliminate the drug because it is necessary to alleviate pain (especially chronic pain) but to monitor and be used moderatly in other meds such as cold and flu medicine etc. making the public aware that acetaminophen is in so many other medicines and adds to the daily dose could help save lives like my sister and many others who have lost people they love due to this. and shame on doctors for being too lazy to require a lousy blood level to monitor it.

[woeisme1]

GeorgeWHoover

Maybe you should'nt post on a public board if you don't care about the publics feelings. And since when did you need to personally know another American before you could care for another American?

[bobnjersey]

[Maybe you should'nt post on a public board if you don't care about the publics feelings. And since when did you need to personally know another American before you could care for another American? ]

maybe you should lower your expectations about what others will and should do ... and how you allow that to affect you ... especially when it relates to postings on an online message thread.

everyone doesn't (and shouldn't) need to worry about meeting someone else's standard of decency. you have the control ... don't read it ... don't watch it ... don't consume it ... if you don't like it. this way ... other's are free to express themselves as they choose ... and you're free to choose to be exposed to it or not.

[kaylag04]

For 200 million prescriptions last year, and untold millions of over-the-counter sales, this report indicates that there were 56,000 emergency room visits associated with acetaminophen overdose. For the prescriptions alone, that's a rate .028 of 1% occurance per prescription. Is that now the Government standard? If so, I can't think of an activity or item that would make the grade. As an example, 200 people die of liver failure associated with acetaminophen OD each year - about 1/3 the number of children killed annually choking on coins.