Will Acetaminophen Drugs Be Restricted by the FDA?


This week an advisory committee voted to ban prescription pain medications Vicodin and Percocet, and to lower the amounts of Acetaminophen in products that we can currently purchase over the counter (Tylenol, several cold medicines, aspirin and Nyquil).  The advisory committee wants restrictions placed on Acetaminophen-containing products to help prevent a possible severe side effect of the drug – liver toxicity and possible deaths due to overdoses.  While the FDA doesn’t have to follow the advisory committee’s suggestions, they typically do.

According  to the news released from WebMD:

Billions of doses of acetaminophen are used safely every year. But acetaminophen-related overdoses cause 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths annually, according to studies done between 1990 and 1998.

For chronic pain patients, Fibromyalgia patients, and ME/CFS patients who frequently suffer from pain, this news is causing some major concern because the advisory committee wants common prescription Acetaminophen containing drugs banned.  Some of these include Vicodin, Percocet, Darvocet, & Tylenol with codeine to name just a few that contain both Acetaminophen and hydrocodone.   The advisory committee voted 20 to 17 that prescription medications that combine acetaminophen with other medications should be eliminated.

The combination prescription products, which have rapidly increased in use in the last five years, are clearly the biggest cause of the acetaminophen overdose, said Marie Griffin, MD, professor of preventive medicine at Vanderbilt University. But she worried that people will simply turn to plain narcotics, if the combinations are eliminated. “We need a broader answer to chronic pain, because these drugs are being used extensively in the older population,” Griffin said during the meeting. “And I am not sure that practitioners feel like they have many other choices.”

Richard DeNisco, MD, MPH, medical officer at the National Institute of Drug Abuse and a panel member, said that so much acetaminophen is going out to people in hydrocodone/acetaminophen mixes that he is uncertain why there is not more liver damage.  Prohibiting these combined products “would rock the system,” he said, but the two products should be prescribed separately, if necessary.

I have taken certain medications, particularly those for Interstitial Cystitis, where I had to have a blood test to check my liver twice a year but all of the years I’ve been on the Acetaminophen containing pain pills none of the doctors have had my liver checked once.  In my opinion, I think instead of these drugs being banned, because many of us do need them, physicians should be held more responsible for making sure they are prescribing the medications properly and testing their patients’ liver functions.   While there are now a couple of drugs FDA approved for Fibromyalgia, it is much cheaper to get drugs like Vicodin and Percocet than it is to get Cymbalta or Lyrica. 

I also think that the FDA should put stronger warning labels on the drugs but it will be a major upset to ban them all completely.  What will chronic pain patients do without these?  Over the counter pain medications do not work and if they lower the amount of Acetaminophen in OCT drugs, pain patients will probably take several pills at once just to try and get a little relief.

The advisory committee is recommending to the FDA that the daily dosage for adults of acetaminophen should be no more than 650 mg.  Currently two tablets of OCT medications contains approximately 1,000 mg. of acetaminophen. 

What do you think is going to happen?  Do you think the acetaminophen/hydrocodone  drugs will be banned?  What will be used to replace them or will they just be prescribed separately?

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  1. I think these people that vote “YES” for this to happen should have to live with fibromyalgia and chrontic fatigue and all the other things assoiciated , for two years of their life ! I have NEVER taking more meds than I was told to take by my Doctor and it makes people like me have to get depressed from the pain you have to get through each day. I think this is a HUGE MISTAKE on the FDA !

  2. I think it’s a huge mistake too, Elaine. There are too many of us in constant miserable pain and we really need these drugs. There is a difference between need and abuse. Hopefully they will get that.

  3. judy johnson says:

    I agree I cannot take nsaids or cymbalta and lyrica only makes me sleep that commercial with a lady at a bakery is humiliating enough most people with fibromyaglia know you cannot eat sugar they had a chance of telling the world of what it was like and chose that! at least it got people talking about it. I guess if they do take it away I will have to back stock now on my darvocet I do not run out like most irresponsible people who claim they are sick. It is that or a stronger drug, I am 46 years old and I barely function as it is taking the lowest dosages that there is…I guess it is that or street drugs since that is the only option left. I have had this for 15 years and have tried almost everything…hopefully they will come up with something else soon and the people who are misusing tylenol mostly people wanting to avoid a hangover will get the hint and it will not be touched.

  4. Over the last 10 years the Food & Drug Administration has implemented several changes in the labeling of acetaminophen to help regulate accidental overdoses.

    – 1998 – FDA finalized a regulation that required all OTC acetaminophen products to include the following alcohol warning: “ALCOHOL WARNING: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.”

    – 2002 – FDA convened an Advisory Committee meeting to discuss unintentional liver toxicity related to the use of OTC acetaminophen. The Advisory Committee recommended a specific liver toxicity warning and distinctive labeling on OTC packages so that products containing acetaminophen could be more easily identified.

    – early 2004 – FDA launched a public education campaign to help consumers use acetaminophen more safely.

    – 2004 – FDA sent letters to every state board of pharmacy asking them to consider requiring labeling on the immediate container of Rx products containing acetaminophen that : (1) uses the term acetaminophen, not APAP, (2) instructs patients to avoid concurrent use of other acetaminophen containing drugs, (3) instructs patients not to exceed the maximum daily recommended acetaminophen dose, and (4) instructs petients to avoid drinking alcohol during prescription use. As of February 2008, no states had implemented regulations related to the request.

    – 2006 – FDA issued proposed regulations for OTC labeling for acetaminophen containing products to require inclusion of new safety information and that the container adn outer carton identify acetaminophen when it is an ingredient. The final version of the regulation is currently under reveiw.

    – 2009 – A meeting of The Drug Safety & Risk Management Advisory Committe recommended that all medicines containing acetaminophen must have it PROMINENTLY displayed on the container or outside carton if applicable. The product label contain new warnings that highlight the potential for liver toxicity and warn consumers against using more than the recommended dose of acetaminophen; using more than one product (over-the-counter or prescription) containing with acetaminophen, and taking acetaminophen with moderate amounts of alcohol.

    It also advised that the product label contain a warning not to use acetaminophen with any other drug containing acetaminophen and to ask a doctor or pharmacist if persons are not sure whether a drug contains acetaminophen, a warning to ask a doctor before use if persons have liver disease, and a warning to ask a doctor or pharmacist before use if persons are taking the blood thinning drug warfarin. that the statement “see new warnings information” appears on the product’s PDP for one year after the final rule is published.

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