FDA Limits Acetaminophen in Vicodin, Percocet and Other Painkillers

  • Written by: Staff Writers

The amount of acetaminophen that is contained in popular prescription painkillers like Vicodin and Percocet is being limited by the FDA in response to a growing number of reports involving liver damage from acetaminophen side effects.

The FDA announced on Thursday that the amount of acetaminophen in combination painkillers should be limited to no more than 325 mg in each tablet or capsule. Many prescription painkillers containing acetaminophen currently have much higher amounts, in some cases up to 750mg of acetaminophen per dose.

Under the new requirements, drug makers will need to reformulate their medications to reduce the amount of acetaminophen or recall the drugs from the market. The limits currently only apply to prescription products, with over-the-counter painkillers like Extra-Strength Tylenol unaffected. The requirements will be phased in over three years and the FDA said it does not believe the limits will cause a shortage of pain medications.

Stronger warnings about the risk of acetaminophen liver injury are also being required on all prescription combination painkillers that contain acetaminophen. The FDA has proposed that a “black box” warning about the risk for severe liver injury be added to all acetaminophen products, which is the strongest warning that can be placed on a prescription medication.

According to the FDA, most of the reports of sever liver injury involved cases where consumers took more than the prescribed dose within a 24-hour period, took more than one product containing acetaminophen at the same time or drank alcohol while taking acetaminophen.

Acetaminophen is the main ingredient in Tylenol and used in many cold medicines, but it is also often combined with powerful painkillers. Drugs affected by the new acetaminophen limits include Vicodin (acetaminophen and hydrocodone), Percocet (acetaminophen and oxycodone), and Tylenol with Codeine (acetaminophen and codeine).

In July, an FDA 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.

During that meeting the panel narrowly voted 20-17 in favor of a recall of Vicodin, Percocet and five other prescription painkillers that combine narcotics with acetaminophen. The panel voted 36-1 that they should carry a “black box” warning if they were allowed to stay on the market.

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.

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  1. d fitz Reply

    My wife has been in and out of hospital since august, 2010.They say her liver problem is due to fatty tissue. She had a knee replacement in May, her other knee was operated on last year. She has ben on vicodine for more than 5 years, due to pain. When they replaced the knee , the pain meds were increased. I think her liver problems are
    tied into vicodine. Very sad.

  2. jeffrey Reply

    2005 i was injured with damage to c3 c4 c5 cervical disc iwas misdiagnosed it was oct 05 through jan 06 before i was called from neurology they put me through 3mo. traction 2x aday.nerveblock shots to neck &shoulder.they wanted to operate but i asked what chance i would have to ever work again they said 0%. so i opted to try physical therapy traction,pain meds. in09 iwent into hepatic coma &liver failure. i came out with hepc showing &abnormal liver enzymes. i still have pain they prescribed norco 325/10mg loratab

  3. C.j. Reply

    My husband and I just saw a commercial for attoneys that were representing patients that have liver damage due to Acetaminophen products. Two of the prescription products, Vidcodine and Percocet are common place in our house. My husband has been taking his Percocet for close to 3 years for his neck/shoulder issues and just recently had tore his achiles tendon and required surgery. Myself, I have been taking Vicodin for many years due to many surgeries on my spine, hip replacements and degenerative disease. I immediately went onto the internet to research this. I found that the FDA is supposed to limit the dosage of the /APAP should on be 325. I just looked at our prescriptions and the Vicodin has 500mg of the Acetaminophen and my husband’s was were it needed to be at 325mg. I just had a full panel of blood work done in preparation for still more surgeries and have seen a slight difference in the liver function panel. I will be addressing this with my doctor. Hopefully, we can stop any future problems. Everyone that takes a medication with Acetaminophen should check your prescriptions and make sure the dosage of the APAP is 325 or lower.

  4. Andrea Reply

    I take a few narcotics for my pain issues, such as chronic fibromialga that flares up and becomes more painful then other days so I use my pain killers to help. I also have scoliosis, my lower spine is twisting, and my c5 is damaged. I see a pain managent doctor everymonth, he ggives me dilaudid 4mg, norco/apa 10-325, as well as gabapentin 300mg. Im allowed to take a lot of these pills a day. I also suffer from pelvic or abdonimal pain but no on seems to be able to figure it out. Could this pain be cause by the medication? Will Norcos be affected by the recall? I hated vicodin because the tylenol was so hard on my stomach it would cause nausea so I used to take promethazine with it.

  5. Barbara Reply

    I was prescribed Vicodin with acetaminophen and I have been taking it for many yesrs. I have had several surgeries due to accidents and some work related injuries that will always hurt. The pain is so bad that I haven’t worked for a long time. The vicodin has caused severe liver damage. I want to stop taking it but I need help to stop because it has been hard to do that on my own. I would advise anyone that is prescribed this drug not to take it because it is very addictive and it will cause damage to your liver.

  6. stryker Reply

    I take hydrocoden 10\325 I was only supposed to take 8 a day but after taking them for so long I was eventually taking up to 20 a day cause the pills just did not work anymore. My Dr has asked me to have a blood test done to check for damages. If I have signs of liver damage will I qualify for this lawsuit?

  7. Anita Reply

    In April my father was diagnosed with Pleurisy! He was in a great amount of pain. The doctor he had seen put him on Vicodin, knowing that many years ago he had a kidney transplant! He was instructed to take Vicodin and tylenol for pain! He was only on Vicodin for 5 days but continued taking tylenol, my father started to turn yellow, he had a hard time breathing, and his urine was amber brown! Right then we knew he had liver damage! We read all the warnings for Vicodin and it states that it can cause liver damage! My mother rushed him to the hospital numerous times before they finally admitted him! We believe that the vicodin caused the liver problems! With further testing we found out he had a tumor that had developed in the liver and grew fast! The doctors believe that the vicodin and tylenol tipped off the liver and progressed things tremendously! One week after my father was admitted into the hospital he passed away! I need to know if we qualify for a lawsuit!

  8. Margarita Reply

    My brother has always been taking painkillers since the age of 9, but for the past several years he has been using them on a daily basis. My brother had a hip replacement and the surgery did not go well at all. He also suffer from ankylosing spondylitis. This required him to take painkillers daily to clam the pain. My brother abdomen it very sensitive to the touch as well as his leg. It feels tender, warm and he is always in severe pain. He has been on vicodin, hydrocodone apap 10 325, morphine patches, morphine pills and the pain is always there.

  9. jeanette Reply

    My husband was dignosed with pancreatic cancer in august 2011 and was put on oxycotina and oxycodone. He lived for two months, and I believe that the medication made things more complicated. He turned very yellow, and felt sick all the time. He passed away in October. When he went into the hospital he was functioning normal and looked ok. But was i a lot of pain. After the medication started he took a 360 drgreee turn for the worse. I am so anger, and confused. was it the cancer or the medication that took his life.

  10. Jane Reply

    Jeanette–I am so sorry for your loss and I understand your anger and frustration. I was an OR nurse and have been disabled for the last 7 years due to numerous problems. While I am not a physician or attorney and I can not give you medical advice or draw legal conclusions, I can tell you that your husband’s cancer and its normal progression was very likely the primary factor in his pain, discomfort and jaundice (yellowness), not the medication with APAP in it. I just lost a very dear friend to the same disease–she lived 57 days after diagnosis. Pancreatic cancer is very sneaky and we need more effective ways of catching it earlier, when there is still a chance for cure or an increased length of survival! I am having problems getting medication I can afford in amounts that sufficiently address my pain. My Medicare administrator is claiming the FDA is limiting the amounts I can be prescribed and blaming them for limiting the amount of meds I get. They are flat out lying to me and others about this issue!! I have spoken to the appropriate authorities about this and the FDA themselves state that, until their new requirements are fully effective in 2014, all meds should be taken AS PRESCRIBED BY THE PATIENT’S DOCTOR. Patients must be cautious about the amount of medication they take, especially when they take it in combination with over-the-counter medications! You must be sure to give your doctor a list of ALL medications you take, prescribed or otherwise and if you have any questions about interactions, also confer with your pharmacist. Only with full knowledge of what their patients are using can physicians make informed judgments about what is best for their wellbeing. I am tired of insurance companies practicing medicine and forcing badly-made generics down our throats. I have very few allergies, and I have had more problems with new generics recently than ever before. They are not working, they have fillers and dyes that are causing allergic reactions and I believe some of them are so poorly made as to be virtually useless! When you go into a hospital for treatment and get only those generics that are included in the “bundled” purchases that are the basis for discounts offered by their group purchasing organizations (GPO’s) just how good an outcome can the consumer expect? Considering insurance and hospital profit margins, who is the real winner?

  11. LINDA Reply

    My husband went into the hospital on 9-11-08 for a routine procedure to have his kidney stones pulverized. He was prescribed Vicodin for pain and on 9-15-08 he was dead.

  12. Steven Reply

    Unfortunately I have no choice in this matter. I was a perfectly healthy specimen that worked out 5 times a week, ran 2 miles a day, bike-riding on weekends and was studying to be a police officer. That was in 1995. May of that year I was headed home from work when i got rear-ended on the highway. I was at a dead stop in traffic and a drunk driver hits me doing 60mph in a old model cadillac. Instantly broke my back, severe concussion, broken hip, shoulder and other injuries. I was diagnosed at after xrays immediately i had a L4 lumbar fracture burst. My L4 was gone in the xray and I was paralyzed from the waist down. I had to have surgery immediately to stabalize my lower back with titanium screws and rods and they took bone from my hip to try and make another L4 vertebra to take the place of the one that was shattered. Very long story short, I regained my legs 6 months later with intense PT after a 5 week stay at the first hospital then a year of PT in another facility. I’ve been in and out of the hospitals since then and have had 3 back surgerys to date. The screws they used in the very first operation that were titanium broke while I was still bed-written. Wonderful right lol! Anyway I never used to take even OTC tylenol for headaches I was always against any medicine unless I had a flu or something but now I had no choice. If I don’t take pain medication I can’t get out of bed and I went thru every alternative to try every type of med or natural meds to take my pain away. Nothing worked and now I have to take norco for pain and xanax for PTSD. I’m no drug attack and never have been but this accident that made me who I am today changed that none to my fault. I have to take pain meds or like I said I can’t even get out of bed. I can’t work anymore, have to use knee braces and walk with a cane now and I’m only 41. I hate having to be dependent on my meds but I have no choice. I can’t do anything even with the pain meds with my own kids like a normal good father I’m always in too much pain. I understand that the tylenol does liver damage in the long term but I ask you Drs that make these changes, I guarantee if you were in my situation you would have a different perspective on this issue. It comes down to the quality of life we can live. We all have an expiration date that is a fact. You committees force people like me to do things I would have never done to attain pain killers any way I can. I didn’t want to have this type of life and didn’t deserve it either but it is what it is. We own our own lives not the government or any agencies for that matter so unfortunately if we have to take pain meds til we die that’s what we have to do. You people that don’t have serious injuries like mine and so many other american citizens are very lucky to not go to bed and wake up with pain 365 days a year like clockwork.

  13. Juan Reply

    I just seeking help about how 9 years of taking norcos hydrocodone 10/325 has left me addicted to them now im disabled at the moment

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