FDA may yank acetaminophen-enhanced painkillers off the market. If you regularly take Tylenol, Vicodin, Hydrocodone or Percocet, you need to read this story. Why?
Two reasons: 1. WebMD.com is reporting that the U.S. Food and Drug Administration (FDA) may yank Vicodin, Hydrocodone, Lortab, Maxidone, Norco, Zydone, Tylenol with codeine, Percocet, Endocet, Darvocet and other drugs like them off the market; 2. According to CNN.com, Foxnews.com, ABCnews.com, the panel making that recommendation points to the overdose risk which could result in liver failure.
Let the lobbying begin.
You can bet that pharmaceutical companies manufacturing acetaminophen, or products containing that drug, will be pulling out all the stops to keep the FDA from taking their products off the shelves. Although some doctors are aghast at the idea, there’s good reason to pull them.
The FDA’s raison d’etre is to be our guardian against unsafe food and drugs. They wield a big stick and put pharmaceutical companies through some stringent paces before a single pill hits store shelves.
Because of it’s massive role as a federal regulator and the enormous variety of drugs it approves and reviews even after a drug has been available for years, the FDA relies on government panels of medical experts to make recommendations about new drugs or studies of drugs that have proven to be dangerous over time or if used in excess.
According to WebMD.com, a government panel making the recommendation to the FDA cites a study that revealed that, during the 1990s, overdoses of acetaminophen resulted in 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths.
But those numbers recorded a decade ago don’t take into account the more recent surge in teenage “medicine cabinet” junkies who take Vicodin or Percocet prescribed for other family members or buy it off the streets. Both drugs with Hydrocodone have become the social highs of choice, and their acetaminophen content is posing some unsettling health risks.
If you take acetaminophen, better known by the brand name Tylenol, once in a while, the likelihood of liver toxicity is remote. If you take it, or any drug containing it, regularly, you should talk to your doctor about alternatives.
Acetaminophen is included not only in prescription painkillers, but in many over-the-counter drugs, such as NyQuil, myriad similar cold remedies, Excedrin, and aspirin-free Anacin, among many others. Because people may take several of these drugs in tandem, they’re at higher risk of damaging their livers without realizing it.
Great show, poor depiction
If you watch the hit TV show, House, you know that it’s weekly storyline has Dr. Gregory House, who lost part of his leg to surgery and suffers constant pain, pouring Vicodin from a pill container directly into his mouth without regard to the number of pills landing on his tongue or the frequency with which he does this. While the show has numerous “longcomings,” the depiction of Vicodin abuse is its greatest shortcoming.
House is the Einstein of “differential diagnoses.” It is he, with his fellowship students, who figures out what’s wrong with patients after other doctors have given up playing “pin the diagnosis on the symptoms.” While he and his crack team always get what disease a patient has, he pops Vicodin as if it’s Pez candy. That gives viewers who take Vicodin the idea that they can follow suit and take as much as they want as often as they want. Very bad idea.
Worse, the show, which sometimes focuses on his addiction and drug abuse, treats the issue as if it’s a wink-and-nod flaw in the character that doesn’t seem to affect his performance. Nor does the show offer any disclaimers about the indiscriminate use of the drug. It portrays House as appearing completely unaffected by his dependency, perfectly lucid and clear-headed, and depicts him driving to and from work on a motorcycle.
Uh, if you’re on Vicodin and you get pulled over, you could get hammered for DUI if the cop figures out that you’re on it.
Prescription combined drugs
Painkillers like Vicodin, Hydrocodone and Percocet are opiates that are combined with acetaminophen to enhance the narcotic’s efficacy. The problem is that, over time, Vicodin and Percocet addicts don’t know that acetaminophen can destroy their livers. And because of their addiction, their chances of getting a liver transplant are right up there with walking to the moon. Demand for new organs far outstrips the supply, and those without drug dependencies and who live otherwise healthy lives, rise up the list. Addicts generally don’t even make the list.
A potentially deadly fake suicide concern
I worked in a Connecticut hospital while putting myself through college. I can remember vividly at least three ER cases involving teenage girls who deliberately overdosed on Tylenol in desperate attempts to rekindle relationships with boyfriends by whom they’d been dumped.
Since acetaminophen is a commonly used drug considered safe and effective for temporary relief of minor pain and fever reduction, many perceive it to be a perfect drug to engage in “attention-getting” but fake suicide attempts, the effects of which are easily counteracted. One of the girls told me that she figured we could just pump her stomach or give her something to counteract it. She was clueless about its toxicity to the liver.
What happens next is up to the FDA
Because its core duties within the government are many, varied and time consuming, the FDA relies on special government panels comprising groups of medical practitioners to review how dangerous, helpful and/or efficacious a given drug is, even long after it has made its market debut. Comprising as many as 30 to 40 or more medical professionals, these panels review studies of drugs, then vote on what to recommend to the FDA.
According to ABCnews.com, the panel in this case was an amalgam of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee, which voted 17 to 12 to have the “prescription combined drugs” taken off the market to reduce the incidence of liver damage.
What seems dichotomous about this is that the panel did not include in their recommendations non-prescription “over-the-counter drugs or combined drugs,” such as NyQuil, Tylenol, Pamprin and Allerest, among others. However, according to WebMD.com, “The panel of 37 doctors and other experts also said that the maximum total dose for 24 hours, now at 4,000 milligrams, should be decreased.”
That may well be because such drugs are taken only for short periods and intermittently by people who have colds and other short-term health issues. As such, acetaminophen presents no long-term-use liver damage potential. But, it is used ubiquitously in other over-the-counter of drugs, which, if taken together, increase the risk of potential liver toxicity.
And CNN.com is reporting that the CDC (Centers for Disease Control and Prevention) tapped acetaminophen as the likeliest cause of most acute liver failures.
While the FDA relies on such panels for recommendations to provide guidance about what to regulate and how, it is not obligated to comply with the recommendations, but almost always does.
For those who suffer from chronic pain and who take Vicodin, Percocet or Hydrocodone for long durations and in higher doses than they would if taking Tylenol alone, should discuss options with their doctors. If Vicodin, Percocet and Hydrocodone are pulled, they’ll need a replacement anyway. Regardless, according to the panel, you’re safer without it.
Opiate painkillers used by chronic pain sufferers are prescribed for long-term use for moderate to severe pain or as relief of what’s called “breakthrough pain.” Many patients who suffer from acute chronic pain, such as back pain, are put on a long-acting and stronger narcotic such as morphine or Fentanyl patches. If their pain “breaks through” the barriers provided by those medications, the patient takes a breakthrough painkiller, such as Vicodin or Percocet.
Alternatives
There are good alternatives to “prescription combination drugs,” so call your doctor to discuss them whether or not the FDA pulls the acetaminophen-enhanced drugs.
Comments
You would have a very lucid and accurate article if you cut out the middle digression, especially the part about medicine cabinet junkies. The FDA could care less right now about a bunch of kids raiding the med cabinet and ending up in the ER getting their stomach pumped. We are supposed to be talking about liver failure. (As a matter of fact, another issue regarding opiates that the FDA is engaged in directly attacks the lenient storage of opiates in the home. If you are interested, follow up with painfoundation dot org.)
But thanks for bringing this to my attention. I am a chronic pain sufferer myself and have many acquaintances who will benefit from having this info. My doctors have always been cautious to give me the lowest dose of acetaminophen possible.
I believe that there are, in the backstage more real and obscure reasons that "safeguarding" USA citizens. Instead of cutting cold-painkillers formula, FDA must had realize that is cheaper and easier to buy real drugs that, prepare your own cocktail from drugs that affect real and in need innocent persons.
Paints, Glues, solvents, and hundreds of products may be used as recreational drugs. If a small group of non-brained is abusing is no real reason for taking out of the market a good product.
That almost 600 deaths are due to this "acetaminophen"?, if so, how many are related to the abuse of alcohol? How many lives are lost because the lack, poor or no attention to minority groups that are not lucky enough to pay a insurance? How many lives are blamed and related directly to medical errors?
Be careful and do not commit mistakes that are making sicker America.
Simple solution: Don't put acetaminophin in with the hydrocodone in the first place! What could be simpler? Gee
exactly
If you take tylenol as directed it definetly will NOT cause any liver problems that will really risk your health. They were only talking about overdosing (or opiate abusers) they didn't speak of any people who took it as prescribed who had any liver problems. If someone downed a bottle of Advil they would end up with a severe ulcer and can die from internal bleeding. This is the last thing the American economy needs, many people could lose their jobs over this. Ofcourse health is the first concern but take that number of 600 and put up a chart with alcohol and Advil for attempted suicide, because that seems to be the only argument. Or you can show a case where someone had health issues while taking Tylenol as prescribed.
I was run over by a truck and will need opiates the rest of my life. I choose to suffer during the day when I need to do errands and never drive after using them (use mostly at night because I am in pain when I have to be still and sleep kind of requires lying down).
Why don't they just take out the acetaminophen? It's not necessary and I think it is only there to poison the addicts. What is going to happen to chronic pain patients who would like to still function in society, instead of having to take stronger drugs that leave them half comatose on the sofa?
Remove the stupid acetaminophen and let people with chronic pain try to regain some of their lives and ability to work. Oh - and I have my liver enzymes monitored twice a year.
I appreciate the government's attempts to insure that we are all completely insulated from the bad effects of living. Raise your hand if you have read, cover-to-cover, the information pages that come with any drug or prescription. Yeah, me either. This is yet another example of absolute numbers versus percentages. It is tragic when a commercial jet goes down, but it is statistically much safer to be in a plane than in your car. 600 people die out of how many billion self-administered doses? And was this product not specifically formulated in reaction to the deleterious affects of aspirin? The FDA has a responsibility to inform the public about inherent dangers, that does not mean that they need to take Draconian measures every time they find something to regulate.
Dave, superb thoughts and kudos for your always well thought-out views. I really appreciate your input. You analysis is right on. The governement always over-reacts to anything and everything. This is no different. Only 400+ deaths as sad as they are, is so small as to be statistically irrelevant. But the FDA will likely do this. It will hurt a lot of people.
Thanks again,
Jim
Thanks again.
James
Hi Anna, thanks for your viewpoints. I, too, am a chronic pain sufferer (back, knees, TMJ) so I'm right there with you. You're correct about the FDA not caring about the med cabinet junkies, but the DEA does care, and that's where things get scary. BTW, there's a new program in place in every state. Whenever you get a script filled, it gets reported to your state healthy dept. and the DEA reviews the records of folks like you and me who need prescriptions. It's Big Brother at its worst, and therein lies the bigger danger to those with chronic pain. Thanks for that Web link. I'll head right to it. I'm deligted to hear that your doc keeps the acetaminophen low. It's very beneficial. I hate prescription combined medications for the reasons in the story. I hope that your pain eases over time. As I said, I'm right there with you. Hang in there.
James
Thanks again,
James
Dan, thanks. Excellent points. I focused the story on the people who can and do overdose, but I did say that if it's taken only when needed, it's safe, and it is. But some folks do take a host of drugs that contain acetaminophen when they're sick and that presents concerns to the panel named. I also agree that people will lose their jobs and in significant numbers, thus the reason why I pointed out that there will be a lot of lobbying of FDA officials to reject the recommendation. What concerns me is that whenever anything like this comes up, people will abandon the drugs being recalled, even if they take it once in a while. Instead, they'll return to aspirin or worse, NSAIDS. If taken long-term, those will give you more than ulcers. They impact your intestines, and are dangerous, especially to those with Leaky Gut Syndrome. Considering the low numbers in the study, I don't think a recall is justified, but that's my view. Stay tuned. I'll be following this closely.
Thanks again, James
Hi Mathilde, I'm a fellow sufferer and I know what you're going through, but don't be concerned. There are alternatives. Oxycodone HCL (there's an aspirin component to Oxycodone HCL/Aspirin), but from what I understand there's also plain Oxycodone, the active painkiller ingredient. In essence, it is really Percocet without acetaminophen. If your body is used to taking drugs like this, talk to your doctor about switching to it. It won't gork you out. Unfortunately, without the acetaminophen it's marginally less efficacious, but your doctor will know best.
Be well and hang in there. There are choices.
James
Hi Kathy, thanks for your comments. Oh, that life could be so simple. The reason that they first combined narcotics with aspirin and later acetaminophen is that, in combination the narcotic component works far better than without aspirin or acetaminophen. Apparently, it moves the painkiller through the circulatory system better and more efficiently. That helps the narcotic component to work better. If you remove acetaminophen from the mix, pain sufferers will notice a difference. Pain relief takes longer and the narcotic doesn't work as well. If the FDA accepts the panel's ruling, it's a moot point. The acetaminophen will have to come out. Check back here for updates.
Thanks again.
James
Hi Darker reasons!!!. You make some very valid points. It's another case of government intervention where it's not wanted, especially since the numbers in the study are so small. If you take a prescription combined drug, your doctor should check your liver enzymes at least twice a year. For those who suffer chronic pain, getting what we need for relief is not only getting harder, but now we have the DEA watching over our shoulders. They should be out on the streets going after drug dealers, not studying the records and then hassling people with legitimate chronic pain. Their first thought is that you're trafficking, without any evidence to support it. That's not what chronic pain sufferers need. Life is tough enough.
Thanks again,
James
James -- Thank you for the attempted reassurance, but isn't oxycodone a higher scheduled drug? I've been told docs are being bullied out of prescribing it and I really do not WANT to have to be on stronger meds all the time. Sometimes I need it after a bad day or a storm that makes me hurt all over, but I try not to because I can't drive if I use it during the day. I'm finally in school and doing volunteer work, with the condition that I don't come in until 10 or so after my pain meds I need to sleep have worn off. I want to work again. I'm scrupulous about not driving impaired and am still afraid that I will have three choices: constant pain, lying on my couch reading comic books with a fentanyl patch (which I could easily get but don't want), or death - none of them very appealing. Oh, or emmigration; that makes four.
BTW - I looked at some old chemistry books. It is trivially simple to remove the acetaminophen from the hydrocodone, but it is illegal. God bless the FDA.
Hi again, thanks James for your info! I am wondering.. there is family drugstore here that will fill (for a lot of $) a Rx for hydrocodone w/o the Tylenol. Did someone remark that is illegal? I live in CA, maybe different here.
The biggest problem folks like me will have, is that I can't take any other pain meds like aspirin or ibuprofen and I react terribly with other opiates. I have used 2-3 Norco for years, with my labs always up to date, never abused it. I don't travel to work, I work at home. To me, there is no reason why I should sit here at the PC in pain for the entire 10-hour workday I usually face. This is absolutely ridiculous.
Another fact?--If 'they' knew more about aspiring today, it would be Rx!!
Thanks so much for your comments.
I doubt they will be able to take these meds off the market because patients in pain will suffer. See patients’ bill of rights to pain care.
They can simply replace the Tylenol with another med with these important medications for people in real pain. They do not want to see every pain patient go to morphine which is what would happen if these are taken of the market IMO
Substance abusers are making things hard for those of us with real medical problems that cause pain and that needs to stop. Most people taking these meds are not substance abusers.
God help those of us with MS or cancer with all this mess.
Thank you all for a dose of sanity. I called my doctor's office today and they said essentially the same thing. If I end up on oxycodone, James is right; it probably won't "gork me out", but I won't be able to drive on the days I take it. Oh, and Kathy -- unless the laws have changed, it was (at the time of my accident) illegal to remove the aceto. from the hydrocodone - supposedly to make it more difficult to abuse without risking your liver. The law was directed at juvenile delinquents stealing granny's meds. Since I don't know if it still is, you could probably google it. No toxic chemicals involved or temperature extremes. And that's all I think I feel comfortable saying about that. Better yet, don't put it in to start with. And my doc has always given me as little aceto. as possible, plus doing blood work twice a year. I still have a healthy liver after almost 9 years, so he is doing something right. Ironic timing - happy "Independence Day" to all.
Jessica, hi. Thanks for your comment. You hit the nails on the head:"Substance abusers are making things hard for those of us with real medical problems that cause pain and that needs to stop. Most people taking these meds are not substance abusers." Don't think for a minute that the DEA doesn't work with the FDA. They see a rise in prescription drugs on the street and let the FDA know. Suddenly, a panel studies it. The whole thing is ludicrous. That there were 400+ death is truly regrettable, but that spans ten years, no nearly enough danger here to yabk the drugs. I very much hope you're right about the FDA not acting on this, but they don't care about us, and my bet is they will adopt it. Doctors are enraged. It's absolutely nuts and without justification. More people die from falling in their bathroom than do people taking acetominophen. Don't you just love government bureaucracies? Wait until the gov. does its healthcare thing. You ain't seen nothing yet, gang.
Hi, Mathilde and Kathy Rose, thanks so much for keeping this thread going. You are real champs. Per your question, Mathilde: "isn't oxycodone a higher scheduled drug?" My wife is an RN, BSN and I checked with her. It is a Schedule 2 with all the drugs the FDA is thinking of pulling. For everybody, the best thing to do is ask your dotor what's available to you. Even if I knew your medical histories, I couldn't do anything more than point out some alternatives, which are growing fewer in number. Kathy Rose, I'm right there with you on the ten-hour days. You do have rights to adequate pain management. How those are met will be determined to some degree by the FDA, but your doctor would know your options. I'll be keeping a close eye on this. Given how close the panel's vote was and the low numbers in a study that spanned ten years, hopefully the FDA won't adopt the recommendation. I'll be praying for you all. Thanks again. James
James, thank you so much for being a logical voice in the wilderness. Perhaps this will all be avoided! So I pray. I appreciate your kindness; that is a rare quality in folks these days! Happy 4th of July! Blessings to all.
Hi Kathy Rose, thank you for the courage to share your thoughts with us all. The minute I saw this story, I seized on it for fellow sufferers. Few understand us, what makes us tick or our willingness to continue on with our lives instead of filing for disability. You're all very brave people and a great inspiration to me. I will continue to do all I can to keep you apprised of developments and I'll keep writing about this because Google News picks up all of my stories. It's my fondest hope and wish that we will escape this arbitrary and capricious (as well as draconian) measure. Hopefully the FDA will reject the panel's recommendation. The study's numbers, especially spanning a decade, are really statistically irrelevant. May cooler heads prevail. God bless you and I'll be praying and writing for you.
James
they do fit in a pez dispencer.
Hi James,
I have one last question; we've kind of beaten this thread to death.
When the alphabet agencies disagree - eg the FDA says tylenol (shorter to write) is toxic and they plan to try to yank all the PK with it, but the DEA says it is illegal to remove the tylenol from your existing painkillers - who has precedence?
I actually agree that tylenol is hepatotoxic, but the procedure to remove it is trivial but not legal. This is starting to remind me of all the political infighting between the CIA, FBI, etc that gave us 9/11. Should we look forward to a biological 9/11 for chronic pain patients? I don't want stronger meds, I don't want a bigger quantity, I just want them to leave me and my doctor alone, because he actually has a medical degree. What a concept.
Hope you had a nice holiday anyway.
I am left wondering if the combination of the aforementioned drugs are a negative repsonse to what is commonly known as 'adictophobia'.
Surely, whether it be for a short duration or a long duration, drugs such as Dia-morphine (heroin), morphine,Dilualid and Cannabis as well other strong narcotic's.
Instead of relieving pain from those suffering pain, I believe that the _fear_ of 'diversion'
is paramount instead of the relief of pain being the overiding goal.
Ian Harris
London
U.K
James, I was reading your article and the comments from others about this. I take Tyenol for my back and for my fibromyligia, but only when I can stand the pain any longer and no more than I'm suppose to. If they are so concerned about our health, then come up with something pain suffers can use that don't have all the side effects most drugs have. Most drugs not all, cause you to feel out of it, because it is to strong. I'd whether take Tyenol, then those drugs, at least I can function. I have taken drugs like Tyenol for yrs. and have had no problems with my liver. If you take these drugs the way you should you want have any problems. If you abuse the drugs of course your going to have problems. Since, they are concerned about our health, then they should take all medications off the market, because all have bad side effects. How would they feel if they were in severe pain and couldn't take what they needed because someone took it off the market? It's not our fault people abuse drugs.
I think the FDA has already voted to stop the use of Tylenol. I am an RN with chronic back and knee pain. My cardiologist said I had a 50/50 chance of dying on the operating table due to my COPD. I still work. I don't want to be on disability. There's no reason that I should have to stop working because of chronic pain. The Norco has 325mg of tylenol in each tab. Leave me ALONE!! Let me enjoy what time I have left in this es
Hi Patty,
I feel for and agree with you. First, some reassurance. The FDA has not voted to remove Tylenol from the market. Second, I believe that quality of life trumps quantity of life. If you're in intense pain, where's the quality? Once again, it's a case of the government meddling in our affairs (they are way smarter than we are about our own bodies, don't you think?) Hogwash! Their focus, and that of most doctors, is longevity even if you are miserable. I don't get it. You'll be able to take your Tylenol. Unless you have a bleeding problem, I don't understand why they switched narcotic mixes from aspirin- to Tylenol-enhanced drugs. I prefer aspirin, but can't give medical advice. It's something you need to talk over with your doctor. Good luck, God bless and prayers for your healing.
I think people should pay attention to their dosage so they won't take certain drugs off the market. Some people use them correctly and they need them. Another thing is I think the doctors shouldn't be aloud to perscribe just anyone pain killers. You can go to some docs and pay 500.00 and get a whole script without a physical. They hand it out like its candy.
My question is who is to say that if they remove the drugs containing Tylenol that patients won't take the straight oxycodone narcotic with 1 Tylenol bought from the local pharmacy? Then you are having individuals self medicating with tylenol at possibly higher levels than the amount in the percocet or other narcotic with tylenol. I think they will cause more harm than good. Do they know what the patients were taking that were hospitalized? Was it a narcotic with Tylenol or just Tylenol by itself/self medicating?? If they are leaving Tylenol on the market by itself then really they are not solving the issue. They actually may cause it to get worse. Just my opinion.
458 deaths is really not a lot compared to all of the people in this country who die of cigarette-related illnesses. Are our lungs not as important as our livers? Why don't they concentrate on taking cigarettes off the market instead of taking medications away from chronic pain sufferers? Once again, the drug addicts are going to ruin it for us all!! I bet the people on these drug advisory panels are healthy people who do not suffer from chronic pain. I have endometriosis, and must take Norco for a week out of the month. The single-molecule drugs such as Oxycodone, Morphine and Nucynta make me very ill and give me rebound headaches. Same thing with the patch. So Norco is the ONLY thing that works for me. So now if they take the only drug that works for me off the market, am I just going to have to deal with it? I would have to be hospitalized every time I got my period. Yeah, really great idea, guys. Way to go!
Sarah, believe me, I know exactly what you're going through "monthly." You are far from alone. I used to consult with The New England Center for Headache in Stamford, CT and they do incredible work to help migraine sufferers. I saw many patients with your exact problem. I'd like to suggest that you talk to your doctor about Imitrex. It's an abortive available in injection and pill form. It tends to bring relief within 15 minutes. But only you and your doctor know your history, so you guys will have to decide if it's right for you. I would strongly urge you to run it by your doc. Unfortunately, credibility can be a problem for many migraineurs whose doctors tell them the headaches aren't real. They are very real. If you get resistance, see a neurologist who will be far more sympathetic. There is hope.
Be well.
hi..sad to say but i have been saying your new discovery for 20 plus years...traditional medical men should be heard.....we saved north America before
I think this is a bunch of crap.while they should be investigating other things they're wasting their time on trying to remove something that help some people manage their pain.I had surgery on both of my feet and I'm in constant pain every single day as soon as I hit the floor in the morning.And this pain isn't a joke.I can't sit and stand for long periods of time because I go numb or I can't walk.I sit and stand, sit and stand all day.What am I suppose to do if they take this off the market .I can't sleep at night because of this pain and this has been going on for almost 6 years .
Got something to say?
Examiner.com is looking for writers, photographers, and videographers to join the fastest growing group of local insiders. If you are interested in growing your online rep apply to be an Examiner today!