FDA Issues Warning for Drugs Containing Acetaminophen

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(Photo Credit: MGN Online)

(CNN) — The Food and Drug Administration is warning against prescription combination drugs with more than 325 mg of acetaminophen, citing the risk of liver damage.

“There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury,” the FDA said in a statement Tuesday.

It is recommending health professionals stop prescribing or dispensing combination drugs that contain more than 325 mg of acetaminophen per dose. A combination drug contains two or more drugs.

Acetaminophen is often used in combination with opioids such as oxycodone (Percocet), hydrocodone (Vicodin) and codeine (Tylenol with Codeine).

The warning does not apply to over-the-counter drugs such as Tylenol, which contains acetaminophen. But the FDA said it will address over-the-counter acetaminophen products in another regulatory action.

“Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much,” the FDA said.

Health risks

Those who have suffered severe liver damage from acetaminophen include people who took more than the prescribed dose, those who took more than one acetaminophen product at the same time, and those who drank alcohol while taking acetaminophen products, the FDA said.

An acetaminophen overdose can lead to liver failure or death.

In 2011, the FDA started asking manufacturers to limit the amount of acetaminophen in prescription combination drugs to 325 mg per capsule or tablet by January 2014. While more than half of the manufacturers agreed, some combination drugs with higher amounts of acetaminophen remain on the market.

The agency says it plans to start the process of withdrawing approval of prescription combination drugs with high amounts of acetaminophen per dose.

–By Holly Yan, CNN

–CNN’s Saundra Young and Val Willingham contributed to this report.


  • Tayor

    I wonder if they realize just how many people actually knew about acetaminophen causing liver damage… Now the exact dosage where the risks outweigh the pros is news to me.

  • Shevette Brown

    I was aware of this that is why I am not big on taking meds. It seems that when you do you trade one illness for another. Example if you have a headache you take something for it and you end up with an upset stomach and you take something for that you get diarrhea
    it just seems that you never really wins.

  • Angie

    I’ve known about the risks and that is why I only take any medications as prescribed. There is a lot of people out there that abuse pain killers and take more than they are suppose to. And that will cause a lot of medical problems and not just liver damage. When I am prescribed any pain killers, I usually take either the prescribed amount or less. I have heard and known quite a few people that got hooked on pain killers and I won’t be one of them. I will only take what will help me be able to function so I can take care of my kids.

  • Linda

    My sister took Tylenol for pain and also
    fever — often. She died of liver cancer.
    Concerns me as I battle colon cancer;
    however I have a degenerative condition
    and arthritis, so only when the pain is that I can’t
    move, I take 2 Acetaminophen for arthritis
    that are 650 mg. each. But never more than
    4 daily for about 2 or 3 days, about 4 or 5
    times per year. Otherwise I grin & bear it
    and try to stay limber & move thru it. I see
    the limit of 325 mg in combination RX drugs, but
    Wondering about taking a total of 1300 mg. total
    per dose?

    • Michael Foley

      Acetaminophen doesn’t cause cancer, just slight damage to the liver over an extended time. It is a similar effect as alcohol, just to a much smaller degree.

  • Laurie

    This is so ridiculous!! This is just another way to make the public think that painkillers are evil! I have chronic pain and Vicodin helps, but the state of Ohio dictates that I have to take other drugs with 20 different side effects due to the SMALL risk of addiction with Vicodin. The drug they put my on to replace it if I don’t wean off of it I can have serious side effects such as suicidal thoughts and rage! Drugs like Vicodin and Percocet are inexpensive and there are 100 new drugs on the market that cost 10 times as much with even more health risk! Over the Counter Tylenol is 500mg and people have been using it for years. I cannot believe people fall for this propaganda! Anti Inflammatories cause more deaths in the US than ANY other medications (look it up). As with all medications, they need to be taken in moderations and under the supervision of your physician NOT the DEA, drug industry or the media!

  • Ann Ford

    I take tylenol but have never taken more than 2 pills in a day and dont take it everyday so far no problems its the ibuprofen thats harmful and its in a lot of pills I know that for a fact my daughter was in hospital because it ate the lining of her stomach so what is really safer I think with liver checks tylenol is best to take

  • Clara

    Tylenol kills your liver motrin eats the lining of your stomach weed dont do nothin but make you hungery why is is still illegal? Oh thats right it wont kill you

  • Michael Foley

    Why do they feel the need to publish a warning for this now? We’ve known about this for the past 20 years? Sound to me like Advil is in the pockets of the Surgeon General.

  • Brenda

    I’m tired of all of these rules being made to protect people who abuse drugs or don’t take them as prescribed. All this does is punish people with chronic pain who take their medications as prescribed and follow precautions.

  • Bob Smith

    The underlying reason for adding acetaminophen to painkillers and not prescribing acetaminophen separately is the powers that be want to poison people using painkillers to get high.

  • D.

    Back years ago at college, we would take 4 extra strength Tylenal Capsules (before the poisoning of the capsules) and then drink all night! Supposedly, that prevented a hangover! Glad those days are way behind me!

  • barb

    I will die of liver failure then. The only thing the doctor will give me is Tylenol, and I take AT LEAST 3000 mg a day, often 4000 mg!

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