July 01, 2009

FDA Panel Votes To Ban Percocet, Vicodin

An FDA advisory panel yesterday voted to recommend a ban on the widely-prescribed painkillers Percocet and Vicodin. Percocet (and its kissing cousin Endocet) is actually a combination of Oxycodone, an almost century-old opioid analgesic medication synthesized from opium-derived thebaine, and acetaminophen. Vicodin is a narcotic analgesic product containing hydrocodone, derived from codeine and thebaine, and acetaminophen. The FDA panel was convened to advise the FDA on how to address tens of thousands of cases of liver damage each year connected to patients taking high doses of acetaminophen either in OTC products like Tylenol or in prescription painkillers like Percocet as well as in cold remedies containing acetaminophen.

Reportedly, FDA data showed that the vast majority of acetaminophen poisoning occurred in connection with opioid-acetaminophen and hydrocodone-acetaminophen combination products, likely due to patients treating pain conditions by taking more and more of the pills to fight off pain, but finding their effects reduced over time and then taking even mroe of the pills and winding up undone because of the acetaminophen.

Earlier yesterday, the panel voted to recommend cutting the maximum dose of acetaminophen in Tylenol and Excedrin, but to not limit the number of pills in a bottle, no doubt a big relief to people who go to Costco and buy their acetaminophen in 1,000 pill bottles--all of which may reduce the effect of cutting dosages.

News of a possible ban on Percocet and Vicodin (and similar opioid-acetaminophen combos) would certainly reduce doctor and patient options for treating pain and it makes me wonder why the panel didn't simply recommend dramatically cutting allowable acetaminophen doses. That said, a ban on the two drugs would be a boon to the makers of OxyContin (Oxycodone plus inert binders) and the makers of opioids combined with either aspirin (Percodan) or ibuprofen.

The New York Times cast matters thus:

"[T]he recommendation is likely to come as a shock to many patients, who may be unaware of the dangers of high doses of acetaminophen--even if they know the drugs contain the ingredient.

"Some doctors already avoid prescribing pills that combine acetaminophen with narcotics like oxycodone (found in Percocet) and hydrocodone (in Vicodin).

"'It ties the doctor’s hands when you put the two drugs together,' said Dr. Scott M. Fishman, a professor of anesthesiology at the University of California, Davis, and a former president of the American Academy of Pain Medicine. 'There’s no reason you can’t get the same effect by using them separately.'

"Dr. Fisher said the combinations were prescribed so often for the sake of convenience, but added, 'When you’re using controlled substances, you want to err on the side of safety rather than convenience.'"

"Still, some doctors predicted that the recommendation would put extra burdens on physicians and patients.

"'More people will be suffering from pain,' said Dr. Sean Mackey, chief of pain management at Stanford University Medical School. 'More people will be seeing their doctors more frequently and running up health care costs.'"

The FDA isn't bound by advisory panel recommendations but often goes along with them.

While it's easy to brush this news off as a matter of patients not knowing the dangers of using too much acetaminophen, my own experience with pain pills is that not once in the several times that I've been prescribed Percocet and Vicodin (for bruised ribs and for occasional use for chronic back pain) has a doctor ever warned me about not taking too many pills due to concerns with acetaminophen. Patients aren't the only ones who need a refresher course on acetaminophen.

It's frustrating to me that two pretty decent painkillers might be banned because of ignorant patients and doctors. It will be interesting to see how the FDA handles the panel's recommendations.

Keep in mind that while some Percocet and Vicodin does get diverted into the illicit drug trade, it's really the purer OxyContin that's causing problems there as it can easily be crushed and snorted, creating an effect similar to heroin (or so I'm told). As far as I know, very few people would crush and snort a Percocet as there'd be no way to remove the acetaminophen (as far as I know).

It's ironic to me that an FDA panel is paying this much attention to side effects from pain pills while similar FDA panels routinely ignore serious side effects connected with anti-depressants, antipsychotics, benzodiazapines and other psychotropic drugs. Go figure.

Posted by Philip Dawdy at July 1, 2009 12:03 AM
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Comments

OMG! Vicodin is this only thing that has helped my back pain that I've had for years and I just got the Rx last year. So all the responsible people out there that need the Rx and take it as they should are going to be screwed because of the few that abuse the drugs. Talk about stupid. More people are going to be forced to take Tylenol more than ever now that the two good pills are going to be taken off the market. How dense can this panel be. I was taking Tylenol probably more than I should before I got my Vicodin. If they take that away from me what are my options!!!!!! This really doesn't make sense, I know I'll be going to the doc more often if I can't get the relief my Vicodin serves. What ding dongs this panel is. FDA, DON'T TAKE MY VICODIN. There are always going to be people out there that abuse drugs no matter what you all ban. BUT DON'T TAKE MINE. You'll just produce a whole new epidemic of Tylenol junkies.

Posted by: tracey stephens at July 1, 2009 05:09 AM

While I doubt that these meds will actually be banned, there needs to be some light shed on the pressure that the AMA and similar organizations placed several years ago on the need to assess and treat pain more aggressively. The first side of this issue I can accept. But the second side has resulted in all manner of "unforeseen" outcomes. My wife works for a medical school and we once hosted a great young doc who was doing an ER rotation at a nearby hospital. She recounted seeing a 17 year old high school girl who had been involved in a minor traffic accident. She did the right thing by seeking a medical assessment. Our friend performed the typical physical exam and pain assessment. They were both in agreement that the pain she incurred was tolerable and did not require treatment beyond OTC agents (Ibuprofen in this case). The attending doc blew a nut when he was informed of the treatment plan. He ripped her a new one and informed her in no uncertain terms that anyone presenting in pain to his ER would not be discharged without a script for Vicodin. This was actually offered to the girl, but she declined as she was scheduled to work a waitressing job shortly and did not want to be impaired (never mind that she felt she did not need a major narcotic).

This story is a close parallel to your earlier post about benzos. These classes of meds are grossly over-prescribed, in my opinion. More so, the recipients of these scripts are not properly educated about how they may be safely (read: briefly) used.

Posted by: Dark Jay at July 1, 2009 05:52 AM

Teachers, if you are working on a lesson plan on drug abuse then this news story is a great one to talk about. These two commonly prescribed painkillers are often abused and used recreationally. When you cover drug abuse or when you are teaching a lesson on science fair project development, go over how medications can be both helpful and destructive.

Posted by: Teacher's Guide to Science Fair Projects at July 1, 2009 09:18 AM

Once again the drug abusers screw the honest folk. Not only do you have to hand over your driver's license to buy cold medicine, now you won't be able to get proper medical care if you have a chronic pain issue. Not that it's ever been an easy thing anyway; all of my doctor's are very leery when writing scripts for narcotics- and I have a degenerative nerve condition that causes chronic pain.

Posted by: Claire Fisher at July 1, 2009 12:31 PM

Of course the apap is only in the vicodin and percoset to kill drug abusers

Posted by: cthulhu at July 1, 2009 03:03 PM

This is absurd. Do you think they will begin pushing for more use of psychopharmacotherapy in cases relating to chronic pain should the FDA go through with this?

As an individual who has dealt with chronic pain for the last three years- and Norco (10-325) Vicodin being the ONLY thing my workers comp doctor with prescribe- what am I to do should this happen? Or my many family members that struggle to obtain pain relievers legitimately? Or as an outreach worker who will see increased usage of illicit drugs like Heroin to relieve issues of pain.

Personally, I use Milk Thistle and other herbs to "purify"(sic) my liver and had to bring up with my doctor concerns of liver damage by use of acetaminophen. He downplayed it- even though daily usage netted a daily regimen of 1,300mg a day. I'm beside myself, as well as many others who will be reading this page.

Thank you for all your hard work. I have enjoyed and appreciated your blog for the past few years and am an aspiring mental health professional who is working as an HIV counselor in two counties at the moment.

Posted by: Giuseppe Cavaleri at July 1, 2009 04:18 PM

It's pretty clear this is more of a move to remove pain killers that are available in generic form than any real honest part of the FDA. After all, *ALL* prescription drugs can be deadly if taken in overdose levels. Where is the logic in BANNING a doctor controlled prescription drug, let alone one of the most common used? And why ban carefully labeled and controlled PRESCRIPTION drugs but continue to allow products like Nyquil and Theraflu to be sold unfettered when they are even less clear in their labeling about containing acetaminophen??? IT'S NOT LOGICAL.

I had back pain the past year and I took 1-2 Vicodin a day and that's less than two extra strength Tylenol equivalents! Over the course of a day! But I can continue to buy Tylenol and abuse it as much as I want, but a DOCTOR(!) won't be allowed to prescribe a BETTER pain killer that would have me use LESS Tylenol because??? Because some idiots in the government think we're too stupid to follow the doctor's prescription? Again, how does that not apply to ALL prescriptions. It's a total crock.

Even more disturbing, I'm starting to see the new administration slowly taking away all our rights and we just let them do it. We're too stupid to manage ourselves so the government will now do it for us....


Posted by: VonMagnum at July 1, 2009 09:18 PM

Chronic pain sufferers aren't looking for a high..they are looking for relief of their everyday pain. Until my doctor prescribed Vicodan for my incurable painful illnesses...interstitial cystitis and endometriosis...I could hardly get off the couch or be a mother to my children. Prior to doctors finally diagnosing me after 5 years of pain...i let doctors cut me open and flip and look at at every organ possible...I was in so much pain. Until my husband took me to another emergency night visit to the corner med clinic when the pain was unbearable...a doctor told me I thought I had overactive bladder and referred me to a urologist who diagnosed me with a scope in my bladder of interstitial cystitis. All those years I suffered. Interstitial cystitis is where the lining of the bladder is damaged and nerves are exposed to your toxins. Think of how often you bladder fills up in a days' time. Well..that is how often I have pain. People always ask...what does it feel like. It feels like a bladder infection all the time. It never goes away. Until I was prescribed vicodan after my diagnosis...I suffered terribly for years. My husband, my kids, and my family felt helpless. Vicodan has made my pain tolerable. The pain never completely goes away and I know it won't. I know I have to deal with some amount of pain...I have an incurable illness. I take 2 vicodan a day and an occasional valium to relax the nerves in my bladder. But the vicodan has given me my life back and allowed me to be a mother to my children. I still can't work. I don't get disability and I don't have insurance because my husband is self-employed. But somehow we manage on my husband's income. We don't ask for a hand out from anybody and I am not a junkie. I am simply a Mom trying to have a normal life. I can take vicodan and function normal and it blocks the pain signals to my brain. Not everyone abuses the medications given to them. So, if anyone from the FDA is reading this...think REAL hard about all the lives you affecting with your snap judgements and decisions about people you really know nothing about. (not meant in mean way). Don't classify people or make assumptions that everyone who uses abuses...they don't. Just please do the right thing.

Posted by: Jan at July 2, 2009 05:59 AM

Good God!!!! So forget about the fact that millions of Americans can drive to any grocery, liquor, chain, bodega, or other store and buy alcohol which causes not only serious health problems aside from the liver but is a major headache for the criminal justice system, but then there there are the plentiful fast food joints where you can consume a week's worth of fat in under 5 minutes. But hell, Tylenol, well that needs to be taken care of immediately!!! Let me see, my guess is within a couple months some big pharma company is going to come out with a new very expensive narcotic pain reliever in which no generic alternative will be available for many years and without the percoset or vicodin alternative in the way-the FDA will have paved the way for millions if not billions of dollars of easy revenue. It all seems just too convenient.

Posted by: Angela at July 2, 2009 08:57 AM

RE:Helpful Government
In an accident someone got run over by a backing up truck, now we all have to suffer from hearing the warning noise of the backing up truck going Beep-Beep-Beep all day long. Which is NOISE pollution that drives people (like me) insane.
How many people are hurt to how many are helped by government intervention?

And there is a solution to the beep-beep-beep noise pollution, a different sound that isn't so bad.A "White" sound/noise generator.

Posted by: mark p.s.2 at July 2, 2009 11:46 AM

cthulhu said: Of course the apap is only in the vicodin and percoset to kill drug abusers.

I've often wondered if that is the case, or maybe just to dissade drug users from taking the doses they need to get high. Obviously it doesn't work. If it did there wouldn't be nearly as many people with APAP overdoses from these combo meds.

Everyone don't freak out! There IS a form of oxycodone (the stuff in percocete) that comes in the same low doses that are used in percocete. But of course those are a schedule II substance - aka you have ot go to the doctor for a handwritten refilll every time. STILL I think that if you have actually chronic pain issues and percocete has worked for you your doctor should be willing to rx you the low dose immediate release form and then instruct you to take OTC tylenol with it.
As Far as Vicodin goes, I do not believe there is still a pure form of that around (without tylenol) so the drug comps will probably introduce it as a new and brand name and under patent drug, unfortunately. But the sane doctors will do the same thing. Rx you the same dose of hydrocodone you usually take in the form of it being mixed with APAP as in vicodin, and just tell you to take the tylenol and whatever other OTC pain meds you use seperately.

Probably the DEA will have to bring the low dose forms of percocette (oxycodone) and vicodin (hydrocodone) that do not also contain acetominiphen into a scheule III realm.

And yes the ONLY reason vicodin and percocete are not schedule II narcotics is because there is tylenol in them and the DEA thought that that would be enough to dissade people from abusing them. I think they forgot that people who are hooked on this class of drugs really don't care about thier livers that much.

Sadly I know a LOT of people addicted to these two medications because they are so easy to get and find (as really they should be because we shouldn't be denying people with real pain effective relief to try and protect the few who are going to find a way to abuse an opiate wether they can get if from rx pills or have to turn to herion because the pills are no longer available)...If they become harder to find and are not simply replaced by versions without tylenol there will be a HUGE and I mean GINORMOUS SPIKE in the amount of people using herion in the USA, at least until the black market is able to start smuggling in these medications from mexicon in the large #'s needed to meet the demand. We will see middle class housewives and business men and people no one ever knew had a drug problem (because they were able to get thier drug of choice thru a doctor and affordable and so did not have to live the life of an addict) suddenly strung out and non-functioning with new found herion addictions.

Honestly, this country needs to get the hell over it's fear of people making thier own choices about thier bodies and lives.

An opiate addiction in the context of the addict being able to dependably and affordably get thier supply is usually undetectable by even those closest to them. Only if they are a true junky, taking these drugs to the point of nodding out (which most users do not), do people realize they have a problem, only then OR when their supply dries up and the cost of thier dope of choice goes up, only then do people realize they have a problem because with MOST PEOPLE who use opiates, they exhibit NO SIGNS of being intoxicated or addicted UNTIL thier supply becomes unreliable and the cost of thier drug becomes to high for them to maintain easily.

I really think we the people need to make the choice to STOP putting people in PRISON because they choose to use a certain chemical substance, unless thier use of said substance leads them to beomce violent type offenders. But even with that, with things like home invasion robbery and that sort of stuff that some people resort to to get the drug they use, THAT PROBLEM would nearly dissapear IF we would JUST MEDICALIZE ADDICTION and be HUMANE and give people who find opiates, or whatever else, is the only thing keeping them going for the time being, ACESS TO THAT DRUG THRU AND FROM A DOCTOR. And at the same time with each visit they have to hear the same lecture about quitting (which they definately do not get from thier street dealers), and be given the same info on resources to help them quit. Take the money we were going to spend putting them in prison and pay for them to get rehab when they are ready to do so (because rehab only works if YOU are the one who wants to get the help)... and MAKE THE ADDICTS PAY CASH FOR THIER DR. VISITS AND RX'S TO PUREER SAFER MEASURABLE DOSAGES OF THE DRUGS THEY WANT TO USE AND THEN TAKE THAT MONEY, WHICH WILL BE IN THE HUNDREDS OF BILLIONS, AND USE IT TO FUND A UNIVERSAL HEALTHCARE PROGRAM.


Addicts are going to find a way to use no matter if the drug is legal illegal, available as an rx or not. The war on drugs has FAILED, it's time to try something new, and it is definately time to STOP PUNISHING those who really need this class of medications just because there are others who take them for emotional pain relief, or just for fun, instead of physical pain relief.

Taking vicodin and percocete off the market in the USA is going to do NOTHING to stop people from getting thier hands on it and stop the tylenol OD's , unless they replace those meds with just pure forms of the active ingredients, at least not in the long run of two years or so from the date they take it off the market BECAUSE the black market and the street level drug dealers and all that will simply start having people run up vicodin and percocette from mexico along with the cocaine and herion they already bring in.

Studies show that 90% of the negative effects of drug addiction is because we have made it a black market affair. As methadone and other opiate maintenance programs have shown, if people can get the type of drug they need to keep thier addiction satisfied, and they can get it reliably and affordably, then they can have lives just as normal as non-addicts. .. In fact they are much more likely to be able to quit BECAUSE they have some supervision by healthcare workers and can work with a doctor or a clinic to make a tailored TAPERING shcedule to safely and painlessly get off the drug when they feel they finaly are ready to do that.

I honestly think the people at the DEA and the FDA and all these regulatory insitutions who think it is thier right to tell people what they can and can not do with and to thier own bodies, even when what they are doing to thier own bodies is not hurting anyone else, they need to get a damn clue and LEARN TO THINK AHEAD TO THE ACTUAL REAL WORLD CONSEQUENCES THE POLICY DECISIONS, AND CHANGES IN LAWS THEY MAKE WILL HAVE ON REAL PEOPLE. They don't do this. They think in a two demensional world, they can't see the complexity that exists, they just think "well we think that it will have X and Y effect that we would like to see happen, so why should we have to think about A B C D E F G H I..... effects it also will have."

WHY don't we require our public representatives and those making laws and policy to TAKE IQ TESTS before we go handing all this power over to them? I know IQ tests aren't the end all and be all measurment of actual human intelligence but it would at least give us a ballpark idea if the person we're about to hand a whole lot of power to is a complete idiot, or maybe has some ability for complex thought.

Posted by: last stop trainwreck at July 2, 2009 12:19 PM

This is asinine. I have a rare chronic pain illness and taking Percocet allows me to complete exercises in physical therapy. Without physical therapy, my illness will progress. And if my illness progresses, there is a chance that I will lose my leg and foot. What is being offered as a substitute??? The other options that have been presented to me is spinal cord stimulation, which is not an effective alternative. This is devastating!!! Just because there are some uneducated idiots that are overdosing on prescription drugs I have to suffer??? Why don't we just ban EVERYTHING that people use in excess? Let's get rid of caffine, butter, alcohol, and tobacco while we are at it.

Posted by: Kim at July 4, 2009 05:37 PM

This is outrageous. They ignore the multitude of problems with antipsychotics, benzos, anti-depressants, etc. - from weight gain/diabetes to sudden cardiac death - but because people forget about acetaminophen we have to ban two of the most reliable and well-known pain pills out there? At least they treat known problems that can't be fudged: either you're in pain or you're not, and something OTC works for it or it doesn't. Doctors should be explaining the basics of metabolism anyway (i.e. - don't drink while taking this, you'll fry your liver). I never even got the "be gentle to your liver" talk with scripts for benzos, Accutane (acne treatment that WILL fry your damn liver), or pain pills - but I had the sense to do some research. It's not like OTC Tylenol gets warned about adequately, at least Percs and Vics require a prescription. Why not just issue reminders to docs that they have to tell patients about liver risks? Then it's on the doc's head if/when there's a potential malpractice suit (powerful incentive for all doctors, no patient would go unwarned).

I have chronic pain. I like to keep some Vicodin handy for when it gets bad. I fill maybe a script a year. Percs make me nauseous. So any form of Oxycodone doesn't sound fun. And as others have noted, I too am unaware of any pure form of Vicodin without the acetaminophen, so I'm betting there will be a new patent and expensive drug if this goes through. I'm not happy about it. It makes no sense. Considering these are the two most widely prescribed narcotic pain relievers, the numbers on liver damage/failure from the accompanying acetaminophen is not compelling. It's not even on the same level as the massive numbers of adverse effects reported for the atypical antipsychotics. And those are abused too (Seroquel in particular, as Phillip has noted). It's illustrative of the tendency to forget that drugs have side effects at all. Do side effects of anti-depressants ever get mentioned? No. We (as a society) have grown so comfortable with throwing pills into our systems, we have forgotten that they aren't magical and that our bodies are not all the same. People trust so called "natural" treatments because they assume "natural" means "safe" - completely failing to understand the concept of adding a foreign substance to your system. So if Percs and Vics get banned because we've forgotten that everything is dangerous at certain levels, I will chalk it up to our society being full of morons.

Posted by: Jordan at July 6, 2009 06:29 AM

Will be interesting to see effects on society considering how common Vicodin addiction is.

Posted by: Sandra at July 6, 2009 11:41 PM

I've been a responsible user of Vicodin for 8 years. In 8 years, I have been so careful, that I have never had to go up in dose. I am aware of the side effects of too much acetominophen. I also don't drink. I use Lortab for intractable migraines.

Calm down, people. They CANNOT ban Vicodin. Or, if they do ban the current formulations, they will leave adequate time for new products to appear. I have some pills that are 10 hydrocodone and 100 Acetominophen, which means that people who take way more than I do, can get more hydrocodone without so much tylenol.

Also, there is a hydrocodone product which has Ibuprofen as the other ingredient. Vicoprophen, I think. 7.5/500 (by my recollection).

I am seeing my own personal doctor to see what he is going to do about his pain patients. They CANNOT ban vicodin, in a sudden or abrupt manner, as millions of people would go into withdrawal, on top of the return of horrific, intractable pain that has driven some to suicide.

I take 1 gram of Seroquel now. I was on Zyprexa before. If anything should be banned, it should be these two drugs! Actually, I wouldn't ban them, either, since I have tried to get off Seroquel and go into withdrawal with nausea and vomitting.

They are so worried about freaking tylenol, and reducing pain, and then they let something like Seroquel or Zyprexa on the market. I have noticed that at least the Abilify commercials no longer seem to be on TV. Thank God for something!

I see the FDA as not caring about people in pain, totally callous, alarming, and with disregard for the public or at least the public experiencing pain.

IMHO, they should just put a stronger warning on Vicodin products, and other Acetominophen, something akin to the Surgeon General's stamp on cigarettes.

Responsible pain patients should not have to pay, for the stupidity of doctors not telling their patients about Acetominiphen and for Tylenol brand's irresponsibility!

Best,
Arianna

Posted by: Arianna Lindemann at July 8, 2009 08:22 AM

NUTZ period. I can see regulating over the counter drugs containing Acetominiphen like they did with the other ones, but a Rx? I have had 3 sergeries, am 26 and walk around with a walker for cris sake. My doctor has recommended me switch from vicodin hp to oxycotten because of tylonol. We have ruled that vidodin is better because oxy makes me feel high and I have 2 kids to look after. he then precribed me narco because they have less tylonol. So whats to say doctors arent doing their best to school patients about Acetominiphen?? mine went through everything to get the daily does down, and explained it in detail. Agree with all they shouldnt ban the rx just because some stupid people want to abuse the drug and make it bad on us legit pain people. They gonna take our guns away next? tobacco is in the all time high now (thanx oboma) now this? come on. isnt that why the dfa approved vicodin in the first place? because it had greater help then risk?

Posted by: Kenneth Nicklowicz at July 8, 2009 08:11 PM

I really hope that they banned these and soon I hope they banned HYDROCODONE TOO!!! I am 21 Year old mom of two boys and I have seen way to many people getting hurt and having to go to the doctor and the dr. will get them a prescription for hydrocodone. But after the script was gone they were hurting so the doctor gave them a refill, and then when the pain was gone they stopped the refill. BUT then he started having pains and stuff so he called the dr and said i need to be seen i am having awful pains in my bones...so he went only to find out that he was withdrawing from the script! If the painkiller wasnt available then he wouldnt be withdrawing...this is a close friend and it hurts to see him go through this...I mean it really does. And I also see after doing research that alot of people like taking these "pills" Just for fun...And not to long ago i knew a person i worked with who took them to and now he is on life support...they should be banned for good

Posted by: Victoria at December 20, 2009 04:53 PM
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