Percocet and Vicodin Recall Urged by FDA Panel Evaluating Acetaminophen

An FDA advisory panel that was convened to review ways to reduce the risk of liver damage and death from acetaminophen, has recommended that a ban be issued on the use of popular medications like Vicondin and Percocet, which combine acetaminophen with other painkillers.

A Vicodin and Percocet recall would have to be approved by FDA, but the agency usually follows the recommendations of their advisory panels.

FDA research has shown that acetaminophen, the active ingredient in Tylenol, is the leading cause of liver failure in the United States. The advisory panel said users of medications that combine acetaminophen with narcotics increase the danger of acetaminophen liver damage and overdose because patients who take the drugs for long periods often need higher and higher doses to achieve the same effect. This means that their livers are receiving higher and higher doses of acetaminophen.

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Following a meeting that began Tuesday to examine 11 different drugs that contain acetaminophen, the panel narrowly voted 20-17 in favor of the recall for Vicodin, Percocet and five other prescription painkillers that combine narcotics with acetaminophen. If the drugs are kept on the market, the panel voted 36-1 that they should carry a “black box” warning, which is the strongest warning that can be placed on a prescription medication.

Vicodin and generics that use the same active ingredients are prescribed more than 100 million times a year in the United States. However, safety issues are a serious concern, as more than 400 people per year die, and 42,000 are hospitalized, from overdoses due to drugs that use acetaminophen.

Panelists who disagreed with the recommended Percocet and Vicodin recalls said that withdrawing the popular medications would create an additional burden on people who deal with severe and chronic pain. Industry critics of the decision also say that the restrictions would lead to more health problems as people were suddenly forced to switch to different, less proven, pain medications.

In a separate vote, the panel voted 24-13 to restrict the maximum allowed dose of acetaminophen allowed in over-the-counter medications like Tylenol and NyQuil. The recommended restriction would limit the OTC painkillers to 325 milligrams per dose, down from 500, due to concerns about acetaminophen liver side effects. The panel also recommended that the maximum daily dosage be lowered to less than 4,000 milligrams.


62 Comments


Denice
I asked my Pain Management doctor to lower the Acetaminophen content in my Percocet 10/650 to 10/325 until I went to my Gastrointerologist (specialist) and he sent me to another specialist in a different state..… that’s where I was told about my liver disease/damage due to acetaminophen content that has “been passed through” my liver in the last 10 years. So , I asked my Pain Mgmt. dr. to prescribe me something else, in which he did a It’s called Nucynta, it comes in fairly strong doses, I was started out on 75 mg, then 100 mg… Look itup on WebMD.com for the BEBEST info on it.

Kelley
I don’t know what I’ll use if they take Percocet off the market. I’ve tried other pain medication but this is the one that has worked for me. Don’t make the people that use this drug as prescribed suffer from the people that abuse it. Just lower the amount acetaminophen in it and tell the patient they’ll have to buy acetaminophen separately.

char
I am tired of people that dont need this drug my daugter had been in a simply car accident that led into our familet Dr providing her vicodineES for a very long time almost a year and a half she came to me at 22 and told me she was not feeling good well one thing led to another here we are 12 years later she went from vicodine to methodone to the streets for the devil it self she was in a world she did not belong in she now has endocardites hep c she just got out of the hospital after 7 weeks waiting on medcaid to help with a 247.000.00 bill hosp only not including DRS you name it thank god our county hospital helped her they are wonderful thank god.sence the last 10 15 years our city has become inffested with addiction crimes famileys having to deal with there loved ones no ins to help can not get jobs drug test I can go on and on I did a cover storie on my daughter front page NUVO magazine Indianapolis Narcodic Slavery if there is away that she could have her life back it would be a god sent BE AWARE to all you young and old this drug she not be used every day 1leads to 2/2leads to 3/3 leaddddddddddddddson and on

Linda
I have taken norco for years due to a buffet table full of pain- (sidebar: try Prozac for migrane; it lessened mine about 75%)- anyway , norco 10/325 was just fine. Then, sometime before 11/16/12, Kaiser switched from Mallinckrodt pharm supply to Qualitest, and these are terrible! I’m going to have analyzed if I can, because I don’t believe there is enough hydrocodone in them to call them norco. And I developed a 10-day cramp in my right side that hurt a lot when I breathe-gall bladder? Liver? Don’t know. But, although it wll cost me a lot, I am taking mly prescription to Walmart who still use Mallinckrodt as of 12/09/2012, because cheap doesn’t much matter if it does not work as prescribed. I feel awful, and can’t get out of bed for the most part, vs. 4 to 6 productive hours a day with Mallinckrodt, so that’s worth checking. And yeah, why do we have to have any amount of liver poison in it at all?!!

debbie
I use the generic Vicodin for chronic back pain. I don’t take alot but when I am hurting it helps. My doctor changed my meds to Norco and I was vomiting severly for days. I was able to get the Vicodin but how long will it be on the shelf to order. Really People, I hope who ever is taking this out of reach never experiences chronic pain.

angel
I have been on percocet 10/325 since. June of o9 i have 2disc herniations in my neck with pinched nerves and a disc at the bottom that is deterating. I can not dunksion at all with out my meds and i am a single mom of 3 kids witch 2 are adhd no way i can go without. My meds would rather die than trying function without them it would be bad

Bryon
everyone takes Vicodin! it is the only medicine that works! just lower the harmful chemicals in the drug and call it a day! as long as you take the stuff as prescribed you should not get an ill effect! as stated in your article! “as more than 400 people per year die, and 42,000 are hospitalized, from overdoses due to drugs that use acetaminophen” not people who are taking the medication as prescribed!

ruth
the fda recently recalled percocet and vicodin because of the aspirin and tylenol affecting the liver and sometimes daeth, I switched to either Roxicet HCL or Oxycodone HCL. They’re small pills and instantly disolves like a baby aspirin and goes directly to the pain in minutes but make sure it say HCL and not / 325/500/650/750 because that means it contains aspirin, tylenol, or codeine. Only HCL should follow the dosage i.e. oxcodone 15mg HCL

Juan
I am a disable male since 2005. Ia m 48yrs old. I have been taking Percocet and Vicodin and Tylenol 3 and many other medications that I lost count, I have a severe problem with my spine, I have a total of 12 surgeries in my body. I require pain medications t all times for my chronic pain. Now I am having problems with my kidneys and urinating and also lower abdomen pain in my bladder area. I am not gonna take any more of these medications if is gonna cause me this side effects, is there anybody out there that is having problems with your kidneys because of any of these medications i will love to read your story because I need to know if it has to do with these medications. Thank you

Trudy
Hello! Wondering if could affect the spot on liver from Prococet? I found out last Aug 2011 and dr stated should go away.. It had been 4 months I had those spot.. had not gone way? So what is chance? Please need your help

nita
I too suffer from chronic pain,fibro myalgia and arthritis.I DONOT abuse my meds but those of you who do are messing things up for those of us who need help.And yes this is America.we should be allowed to choose.for me,it’s worth the risk.I truely could not function without some form of help.

shawna
They are now on TV showing that you can file a lawsuit if you’ve had liver damage or died from percocet or vicodin. And that a black box warning has been issued for them. I also take percocet for a surgery that I recently had and chronic neck pain. It is the only pain medication that helps with the pain. So what are we supposed to do if they completely ban it? I have never had any problems with taking it. I think the problem is people that are addicted to these medications. And taking more than they should. They are going to ruin it for everyone, including the people that really do need it for pain.

scott
I was in an auto accident and tore my ACL in my knee the doctor perscribed me hydrocodone and have been taken this medication as perscribed and have had to go to the hospital with severe chest pain after taking this medicine for a couple of years or so and i stopped taking this medicine after hearing about the recall and i still have a lot of haert yorrithmia I even called my doctor complaining of chest and back abdominal pain but feel better now that i quit taking it what should i do about this?

deborah
my father had replacement on both knees year ago and they start to give if pain again. the doctor gave him one pain killer but it didn’t work. so he then got a [res. for vicxodin. he took it for 1 week or maybe 2. he start have mood changes and we found out after we rush him to the hospital the his liver started putting out amodia and the liver started to shut down. he pasted away on june 16,2010 on his birthday and mine.

Donald
Stop and listen!!- They are not talking about hydrocodone or oxycodone (the active opiate in vicodin and Percocet), they are only limiting (or removing completely) the acetaminophen (the Tylenol portion) from the pill. Pain clinics have already been doing this for years (they prescribe oxycodone and vicodin without any acetaminophen in it at all). But you have to remember, when doing this; the pill won’t be as strong. Any opiate plus another pain reliever will make it more effective (it can be aspirin or ibuprofen or tylenol). Even one aleve mixed with half a vicodin will better control pain levels just one vicodin with no aleve. This is why there is vicuprofen (hydrocodone & ibuprofen), Percodan (oxy & aspirin) and other mixes. I agree that this whole thing is being done because of addicts (I have seen my brother take 5 lortabs at once just to feel ok) – yes, he died at 21 with his whole future ahead of him due to an overdose of methodone (ironic…had he just had his vicodin, he would have been OK). He was trying to find other methods to control his pain.

Donna
I have bone problems ,Ruetiod arteritis, osteoartheritis ,chronic pelveic inflamitory diease..from scar tissue, caused by surgeries over the last 20 years….I don’t understand why they will not get of aceteminafin ..if that is the killer….cause when a doctor puts you on a narcotic and they know they are highly addictive and don’t care what happen’s to you once you are addicted ( and I mean takin as percribed and less to stretch it out to at least dull the pain) the first thing they do when u go to ER…no matter how sick you are ….a drug test to see if you are taking any kind of narcotic’s and if you are ..you have wasted your time…..no matter if you have your own…they treat you like you are a diease…I feel everyone should have the same health equally..as of quailty of care….

Danielle
I am 24 and have had to use vicodins for over 3 years due to alot of health problems that I have. I also have been a C.N.A. for 6 years and seen how much certain diseases can cause so much pain. People need a strong pain medicine to take care of this and vicodins help them. Take the tylenal out of the pain medicine or lower the dose in them, that would make more sense that recalling all of it. Do not take this medicine away from people that honestly need it.

Debi
I live with chronic back pain and migraines on a daily basis, without vicodin and percocet I would be bed bound. I take my medication as perscribed by my doctor, they test my liver every six months. I to date have not had a bad BUN test or any other test that would indicate a liver problem. But while on Moltin my liver (BUN) test came back bad, and I was taking it as perscribed. The Doctors took me off Moltin and my live tests returned to normal. If we as adults can not follow Doctor written orders than we are doomed. But if we follow Doctors orders have regular liver test we can head off any damage the drugs may cause. I also live with Fibromyalgia, I take high doses of Gabapintin which is suppose to help my fibromyalgia, and prevent my migraines. I still have migraines just not as often. But when I do have one Perocet is the only drug that helps with a migraine next to Hemp. Marjuana is legal in my state thankfully, if it were legalized across the united states it would be a much safer drug of choice for pain relief. Don’t take these drugs off the market, just take those that abuse the drugs out of the picture. Require liver test every three months to watch for liver damage. Don’t take away a drug that so many people depend on to live normal lives. If Tylenol is so bad why not take it off the market too. OTC drugs are abused just as much as perscrition drugs. We must be given an alternative to not taken these drugs, however, it should be the patients right to be informed of potential dangers and decided for themselves. Not the FDA.

sara
My beautiful young cousin jude died from overdosing on Vicodin. She had chronic pain from a car accident that almost killed her. People who take these pills don’t understand their dangers. They build up in your system and you develop a tolerance to them. In order to get the same relief you once did from them, you take an extra pill and next time, another. It’s a really bad drug with a very bad track record for effectiveness. People be forwarned and be careful!!

Sherri
This is in response to JANET: “If anyone has another more constructive remedy for this pain, please advise.” 2 thoughts: 1. Lyrica has REALLY been a mainstay drug for me for going on 2 years now. I know it helps from the few times I forget to take it. It does have to be increased ever so often. 2. Another thing if it’s a higher inflammation season for me, I cut back on certain foods that I learned actually CAUSE the body added inflammation. The worst one is TURKEY, (chicken isn’t so bad) and also night shade veggies. My biggest trigger is tomatoes (I LOVE THEM so that’s tough. But occasionally I go back to them during seasons the pain is less.

Janice
This is for Janet, try homeopathic it works!!

Janice
Went into a coma for 21 days May, 2010. Liver failure from taking my pain meds which were loaded with Tylenol. I almost died. Now I am stuck with over $200,000.00 in medical bills! I no longer take pharmaceuticals for pain in fact, I have experienced far less pain without the meds than I did with them…go figure.

Petunia
“I never heard such ridicules statements in my life. What a bunch of addicts. I took over the counter drugs such as Tylenol, Ibuprobhen, Naproxin Sodium etc. for my arthritis pain until it made my reflux and irritable bowel syndrome worse than the arthritis. Then I was on Celebrex for arthritis pain along with Prilosec for reflux. This led to an episode with my heart. Then finally relief, my doctor put me on Mobic and three Acetaminophen per day. I took only 2 Acetaminophen and my Mobic for three years. Unfortunately this caused my kidneys to fail. Now I’m on three Acetaminophen per day as originally told to do. This doesn’t help much at all. He then put me on 2 Hydrocodone per day. I tried this for a week. It was no help at all. I went back to the 3 Acetaminophen per day. Since going off the Mobic the Arthritis is so much worse than I ever experienced previously. I am getting worse every day. I take a lot of supplements such as Glucosamine, Chondroitin, Omega-3, Flaxseed oil etc. I can’t sleep for the pain. I still struggle with the pain. There are days when I can hardly walk but I keep on keeping on. No hard drugs for me!!! If anyone has another more constructive remedy for this pain, please advise. I do use heat and some other topical remedies. All I need now is to have Live failure from the tylenol in my Acetaminophen. Wouldn’t that be a kick!!!” Ahh, I love the smell of self-righteous martyrdom in the morning. You call people who are managing their pain with drugs you don’t approve of “a bunch of addicts” then bitch at tedious length about your chronic pain and act as though you deserve a medal for refusing to consider narcotic therapy that could significantly improve your quality of life. Shut the hell up.

Kendall
I have been taking hydrocodone for about two years.I be having irregular breating,irregular heartbeat,Nausea,vomiting,constipation,lightheaded,dizziness,drowsiness,vision changes,mental moods almost everyday.when i try not to take it for three days my body still be needing the medication for my pain.I hear echoes when i be in the shower and also i have leg tremblers.

Janet
I never heard such ridicules statements in my life. What a bunch of addicts. I took over the counter drugs such as Tylenol, Ibuprobhen, Naproxin Sodium etc. for my arthritis pain until it made my reflux and irritable bowel syndrome worse than the arthritis. Then I was on Celebrex for arthritis pain along with Prilosec for reflux. This led to an episode with my heart. Then finally relief, my doctor put me on Mobic and three Acetaminophen per day. I took only 2 Acetaminophen and my Mobic for three years. Unfortunately this caused my kidneys to fail. Now I’m on three Acetaminophen per day as originally told to do. This doesn’t help much at all. He then put me on 2 Hydrocodone per day. I tried this for a week. It was no help at all. I went back to the 3 Acetaminophen per day. Since going off the Mobic the Arthritis is so much worse than I ever experienced previously. I am getting worse every day. I take a lot of supplements such as Glucosamine, Chondroitin, Omega-3, Flaxseed oil etc. I can’t sleep for the pain. I still struggle with the pain. There are days when I can hardly walk but I keep on keeping on. No hard drugs for me!!! If anyone has another more constructive remedy for this pain, please advise. I do use heat and some other topical remedies. All I need now is to have Live failure from the tylenol in my Acetaminophen. Wouldn’t that be a kick!!!

karen
This tylenol in everything IS a major problem. I am 62 year old with major chronic pain (for the first time in my life.) I have never taken narcotics before. I was on a Fentenyl patch for a while , wonderful pain relief, but could not stand the side effects. Got off that. Now I have Percocet and Darvocet. Sometimes ALL I WANT is 3 tylenol to see if that would help. ( I cannot take any anti-inflammatories due to a kidney problem.) If I take the plain tylenol and it does NOT relieve the pain, then where do I go? I have NO OTHER OPTION for a pain reliever as everything else also contains tylenol. YOu can’t get away from the stuff. So you sit in pain. If it’s bad enough you have to go to the ER. Very poor option. The only thing this “tylenol in everything” does, is get you to reach for whatever narcotic you have , without the tylenol FIRST, because you know if you take just tylenol or the pill with the added tylenol, you have NO further options for pain relief. It’s just horrible for those of us with serious ongoing injuries. What was the rational for this putting tylenol in everything ???

Rosa
1st off those making insensitive and stupid comments about all opiod users being addicts have never suffered debilitaing chronic pain.Not denying there is abuse – but there are also millions of responsible users just trying to live a life. You know that incredible pain when you get your fingers slammed into something – up that a dozen notches and have it never subside! I’ve been a health nut all my life and tried every alternative remedy available – after 3 botched neck surgeries post car accidents – I was ready to end it and I know what it’s like to pass out from the pain. Percacet was my only relief – I had bad reactions to everything else. I take as little opiod medication as possible and with much break through pain to maintain the same dosage and would rather be medication free with all the stigma connected with it. I’ve been leary of the tylenol for awhile now – lately I’ve had liver syptoms despite taking Milkthistle – I’ve been on medication 8 years now. I just lost a loved one to Liver Disease and it was agonizing. I would like to have choices in my own health – I was told by the Pharmacy you can get Percacer Tylenol free – but Drs. don’t like to prescribe it that way ? Why? My vote get rid of the Tylenol.

tim
I take the 10/325s to as to limit my Tylenol. I think the issue here is the Tylenol. I think you will still get your meds just without Tylenol which they have been reducing anyway. I have been sitting here for three days dieing. I was thinking it was my bad back so I took a extra pill as I was still under my daily number it did not help. I am thinking it was my kidney. Heck maybe it is my liver. Guess where see if it goes away. My doctor gave me the talk about taking this amount and no more so I do. I doubt there just pill the meds off but more likely the Tylenol out of the meds.

Fmlyons
I have sarcoidosis. Among other things I often have severe jointpain. I have no insurance and can’t afford to dr. shop. Any one have any referrals of doctors in Los Angeles who aren’t hesitant to prescribe what i need?

Maria
I read not too long ago that the reason they put tylenol with the opiates was to make them toxic to abusers, not to improve pain relief. Anyone else read that?

stephen
I’ve read alot of comments on the matter of pain pills. I don’t believe the pills are the problem. I’ve had 5 back surgeries with cages and rods, screws all in my back and the pain is all day every day. i use to take the lortabs percocet and oxycontin. I now take morphine and my pain is managed enough to make it through the day. I don’t wan’t to think about not being able to take the meds. for my pain. I’ve been on the meds. now for 15 years and there is nothing wrong with my liver

April
Not all Chiropractor’s know what to do. Actually, I know most of them don’t know. I worked for one for years and I went to their “conferences.” What they are taught is how to keep the patients coming in for weekly and bimonthly treatments. I sat in on all the “tactics” on how to bill the insurance company, how to x-ray the patients so they can have other treatment interventions such as, hydrotherapy, ultrasound, and massage, with many others. They try to sell vitamins, do blood work and the whole gammet to get the patients coming in. Especially patients who have good insurance and workman’s comp claims. When I learned all about this I investagated the whole clinic and found out they were keeping double payments from workman’s comp claims, rebilling old patient claims when they didn’t have insurance,and billing their new insurance with new dates of service. When I had all the proof, I turned them in! Watch out folks. Research your doctors on the internet, and check to see if they are redflagged. Also, check the state board of medicine in which they practise. It is free to do this. Be your own advocate and protect yourself. Don’t be afraid to ask questions and ask for your own results of his findings.

taaheatea
I have suffered from severe Reflex Sympathetic Dystrophyin 1995-1996 and ended up having two major surgies on my spine to cut the nerve ganglions. It put me into remission for 10 years until I suffered a severe debilitating spinal injury that required four spinal surgeries. Now I am disabled. That injury in July of 2003 has brought back the severe RSD pain. If anyone knows about nervous system pain, they know there is no cure for RSD, only management. I have to take strong long acting narcotics and one with tylenol in it for breakthrough pain. I am a nurse and I follow the doctor’s instructions of my pain medication. It’s the people who take over 4,000 mg of tylenol or iburprofen in a 24 hour period that are damaging their livers. If this drug is cut from the market, I am afraid of what I will have to do to control my pain. We need more research and funding for people who suffer severe debilitating pain.

Ross
There is episodic evidence from suicide attempts using Tylenol that survivors have liver destruction and siginificant brain cell loss. It needs investigation. The Hypothesis to test is based on the possibility that areas of the body with the highest blood concentration are in the most danger. Furthermore, Parkinson’s Disease is on the increase in the United States and it is a depletion of brain cells and doctors typically recommend Tyleno to these patients..

Judi
I also suffer with chronic pain. I go to a Medical Rehabilation ctr. I take up to 8 generic percocets a day. They have a total of 2600 mg. of tylenol which is under regulations. I do not believe that after taking mophine, and oxycontin I would ever want to take them again. I also take cymbalta which helps with neuropathy pain. Tylenol never ever did anything for me. And, I cannot take anti-inflammatories. I don’t think that the 325mg, will be a problem unless you’re taking more than you should. I hope nothing changes with my meds..I do much better on them. I hope all of you will be alright.

chloe13
Percocet and the other drugs with acetaminophen had better not be recalled.My family can’t take any other meds.We all have bleeding diseases.The other drugs all act like blood thinners and I don’t particularly feel like possibly bleeding to death.It was bad enough when they took the good meds for coughing, flu and colds off the shelves.God knows I really enjoyed watching my kids choking on their own blood.And trying to explain to clueless ER doctors and CPS idiots that their bleeding was from the violent coughing and a bleeding disease and not TB or from beating them.That sure was fun.And trying to tell a doctor that all they needed was clotting factor and the good cough syrup was like beating my head against a brick wall.If the FDA does this recall, it looks like I’m up s@#t creek without a paddle!! Not allowed to treat my children at home,have to go to the ER,huge drama,more accusations and too little help almost too late all because some stupid parents can’t read the directions “do not give more than directed(see overdose warning)”.Thanks.

Beryl
I have been prescribed vicodin off and on for a few years and was just given another prescription. I have noticed doctors are prescribing this drug frequently especiall for cancer patients. My husband who passed away in May had metatastic colon cancer that caused his liver to fail. I wonder if vicodin had anything to do with it???

kristina
I take 10/325 perc’s a day as well as kadian which is morphine after so many injuries and this is the first ive herad of them wanting to take tylenol off of the market. my doc will si,ply give me meds without rtylenol inthem like patches or strait morphine. simply said who needs tylenol but children and if they do need it we can still get their temps down with luke warm baths and popyciles alot of TLC will go a long ways theres other things besides tylenol. such as ibu’s and aleve etc/ dont panic. think it thru and find a better doc if yours is too dumb too thnk and talk to you. just my two cents worth I already burned up u gallbladder due to tylenol lol ,thats what they told me to do ,take more tylenol until the glorious referal! and shiney new educated doctor could take a ook at me said oh my gosh what have you been dong?

karmagirl
I take Lortab 7.5/500 up to 6 a day. All the doctor is doing id increasing the amount instead of trying something else. This whole issue of acetaminophen being bad for our liver is scary. Doctors get paid to keep your scripts flowing. What happens to your liver or anything else doesn’t matter to them. It obviously doesn’t matter to my doctor at least because instead of listening to my concerns about all this he increased it again, yes its the doctors who are idiots. And no, I DO NOT take that many a day. With the doctors knowing what they know about all these meds I seriouslly doubt they would take them as they prescribe them to their patients let alone take them at all!!!!

Charmaigne
I also suffer from daily severe chronic pain and take not only high dose oxycontin, but six to eight 10 mg pecocet every day in addition to about every other narcotic known to man. I’m not disputing the fact that high doses of tylenol are exceedingly dangerous, but to recall these narcotics without having any replacement pain relievers available to those with chronic pain is not only irresponible, but it’s cruel. to those who suffer from sever chronic pain every single day, I’m sure most of you would agree with me. When you can’t get out of bed without painkillers due to the severity of the pain, you must have something that allows you to get up and live. If the FDA chooses to recall these drugs, they MUST have some kind of alternative available to concumers.

KN
Seriously? Isn’t the issue that the drug, in and of itself, is not dangerous, but rather people’s stupidity about correct dosages is inherently dangerous. Why don’t we just ban stupid people instead? If you are so mentally incompetent and to not read or have read to you the warnings that come with each and every prescription, how is this MY issue or anyone else’s? If you OD because you are an idiot and lack common sense (see: Michael Jackson, Anna Nicole Smith, etc), this is the old survival of the fittest taking over. In this case, it is the mentally fit.

Pithius
The FDA Meeting Issue Background Document is at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM164897.pdf Options 1(a) and 1(b) propose limitation of acetaminophen to 325mg per dose for OTC sales (and possible inclusion of all prescription formulations). Option 5(b) proposes eliminating all prescription medications complexed with acetaminophen. What is not (directly) stated by the FDA is the single most significant factor at play. Hydrocodone (Vicodin, Lortab) complexed with acetaminophen is a Schedule III medication. Hydrocodone (alone) is under Schedule II. And there currently is NO SUCH PRODUCT manufactured! Thus, the FDA [if they choose to vote for Option 5(b)] will (effectively) “re-schedule” hydrocodone from Schedule III to the *much* more restrictive Schedule II (written prescriptions only, maximum 30-day supply, etc.). Addressing the current non-existence of any hydrocodone (only) product, the FDA Background Document (lazily) states: “For development of hydrocodone single-agent formulations, implementation would include:” … “Submission of NDAs and ANDAs for single-ingredient hydrocodone products, which may also require clinical studies for demonstration of efficacy.” A reported 460,000 prescriptions for hydrocodone with acetaminophen are written and filled every business day in the United States. (Despite) the fact that the public comment window has passed, all affected patients, physicians, and institutions would be wise to protest – loudly.

NY
Try going to herbs and minerals….The chiropractors knows what ones to give you for pain……

Cindy
I cannot believe the FDa IS EVEN CONSIDERING THIS. Too many people will be affected. i live in chronic pain and cannot image how horrible it would be without pain control. This is America we the people should have the choice if we want to take something. Everything has side effects and sometimes the benifits out way the risks.

Wanda
I hope that tylenol is not banned i have had both my knees replaced within the last three years and have been taking the generic percocet. It is the only thing that helps my cronic pain. What are we to do ? All the medications my DR. has tried me on has hurt my stomach or didnt help.I hope there is an alternative to banning percocet.

John
The base medications ( Hydrocodone for Vicodin/Lortab and Oxycodone for Percocet) are available in the market without the acetaminophen included. Everyone will still be able to get their pain relief, only the name will be different. Acetaminophen will still be available, just not combined.

Gena
My husband and I are on Percocet. My husband is on Percocet 10mg 325 name brand only. When he gets the generic and I can only get the generic you can taste the acetaminophen when swolling it. The name brand does not contain as much. The Dr.s & pharmacists will even tell you that name brand medicine contains more of the narcotic which helps your pain ALOT more. If they are going to recall any pain meds then they need to take Methadone off the market. It has killed people. They give it to people that are addicted to opiods and to me that’s trading one drug for the other. What are people such as me with chronic pain due to rods in my back and several stomach surgeries which has caused my stomach to be a big ball of scar tissue & my husband that has had 3 back surgeries and has a paralized foot and extensive nerve damage going to do? When they put us on a different medicine it won’t be as strong meaning we would have to take more and as some of you said,there are ALOT of other medicines on the market that are WAY worse.

Mary
It’s ridiculous that there might be a ban on acetaminophen! Medications containing acetaminophen are the only things that help when I have a migrane or bad cramps. My doctor prescribed me vicodin to help with the pain I experience while I am on my period, and it is the only thing that helps. Any rational person would realize that there are risks involved with taking large amounts of acetaminophen, and take the proper steps to keep themselves from experiencing negative effects. The rest of us should not be expected to suffer just because some people are too stupid to realize that their health could be affected adversely if they take more than the recommended dose.

LA Confidential
You all make yourselves look like a bunch of pill junkies…-get rid of Tylenol NOT the other stronger pills with more devastating effects-…you’re idiots! I watched my mother quickly decline because she had ‘constant’ back pain….she was addicted to Vicodin….NOT Tylenol…wake up people…you’re not supposed to routinely put ANYTHING into your body…especially pills that are known to be addictive and harmful…..

Jonell
Here is what people are not understanding. People are not going to be at risk if they use acetaminophen in moderation. Like any drug, there are side effects and if used in any way other than how a physician prescribes will cause these side effects to increase. The truth of the matter is that if a person takes too many motrin, or ibuprofen, (as well as other OTC and presciption medications) that it can be just as harmful. As for the Vicodin and Percocet, I agree that if there was no acetaminophen in them they would be less effective yet a little bit safer. Anytime you are dealing with narcotics people are going to be abusing them. That is their own fault. If they abuse the medication they deserve to have liver failure if they are really that stupid. The majority of people do not follow the physicians orders, nor do they follow the directions given on OTC products. No matter what the FDA does, it will not change this fact; people prefer to be their own doctors.

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