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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.

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.

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62 comments

  1. shawna Reply

    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.

  2. nita Reply

    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.

  3. Trudy Reply

    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

  4. Juan Reply

    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

  5. ruth Reply

    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

  6. Bryon Reply

    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!

  7. angel Reply

    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

  8. debbie Reply

    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.

  9. Linda Reply

    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?!!

  10. char Reply

    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

  11. Kelley Reply

    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.

  12. Denice Reply

    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.

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