Tylenol Liver Damage Side Effects Warrant Stronger Warnings: FDA Officials

FDA officials released a report yesterday in advance of an independent advisory panel meeting scheduled for next month, indicating that stronger warnings are necessary about potential side effects of Tylenol and other painkillers containing acetaminophen, due to the potential risk of liver damage.

The report was released by an FDA working group studying over-the-counter acetaminophen, to provide information for the panel of outside experts convened by the FDA to weigh the drug’s risks and make recommendations about what, if any, regulatory actions are necessary. Although the FDA is not required to follow the recommendations of their advisory panels, they often do.

FDA officials indicated in the report that more stringent warnings about Tylenol liver damage risks are necessary because high doses of acetaminophen can cause serious injuries. Such high doses could occur unintentionally, when consumers do not realize they are taking multiple medications with the drug as the active ingredient, which is common in pain relief and cold medications. In addition, the use of alcohol together with Tylenol or other acetaminophen drugs also could increase the risk of liver damage.

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The working group also suggests that an adult daily dose limit on Tylenol should be set at 3250 mg, and that pills be capped at 325 mg each.

If the Tylenol recommendations are adopted, acetaminophen-based medications would have several new warnings, including:

  • Warnings that taking more than recommended amounts can cause liver damage
  • Warnings that the products should not be combined with other medications that include acetaminophen
  • Highlighting acetaminophen as the active ingredient
  • Warnings for alcohol users and people with liver disease regarding increased liver damage risk
  • Warnings regarding the need for prompt medical attention after an overdose, even if no symptoms of a health problem are present.

Aceteminophen or Tylenol overdoses are a leading cause of acute liver injury in the United States, resulting in 56,000 emergency room visits, 26,000 hospitalizations and over 450 deaths annually between 1990 and 2001.

These drugs are used by millions of Americans, both adults and children, for pain relief and to reduce fevers and combat cold and flu symptoms.

The advisory panel is scheduled to meet June 29 and June 30, 2009, to review the safety issue.

8 Comments

  • WendyApril 27, 2023 at 3:19 pm

    Move those old items off of the shelf !!!

  • PaulaFebruary 1, 2013 at 5:06 pm

    I have suffered for 20 years in EXTREME Cronic back pain, Nerve pain and Fibromyalgia. I now am dealing with constant stomach pain from having my gall bladder removed and a hernia mesh surgery as well-this was in the last week of September 2012 that i had both surgeries done-they had to remove fistfulls of scar tissue due to my spleen rupturing in the same car accient that I also had a T10-L1 comp[Show More]I have suffered for 20 years in EXTREME Cronic back pain, Nerve pain and Fibromyalgia. I now am dealing with constant stomach pain from having my gall bladder removed and a hernia mesh surgery as well-this was in the last week of September 2012 that i had both surgeries done-they had to remove fistfulls of scar tissue due to my spleen rupturing in the same car accient that I also had a T10-L1 compression fracures of my vertebraes. I have to take 2 different pain-pills , one long-acting twice aday and one 4 times a day ffor the break thru pain. My back pain is finally under control most of the time-however, the area of the hernia mesh surgery is still causing me alot of pain and swelling. I am 44 years old and look at least 5 months pregnant on my best of days. I am trying to wait on our tax money so that I can get a second opinion regarding the hernia mesh. I feel a square corner protruding thru my skin along part of the scar at the exact place the hernia mesh was placed-I am scared and still work part-time thru a staffing company-I never know when the pain will be too much so I cannot commit to a permanent position with a company. I have no health insurance because where my husband is employed-it would cost us $1000.00 per month just for me to be added for health insurance. I tr my best not to take the pain medicine that has the tylenol but I have a wonderful and teens that need me very much-I have to maintain being a good mother and housewife because of the hours that my husband works. My step-son does help some but the majority of all housework, laundry and cooking is my responsibility. Are there any federal programs that can help me with medical issues? no-there is not because we make too much but too little to afford all the medical doctors that I really need-its damn if you do and damn if you dont so I leave it in God's hands because I cannot carry this burden by myself. I am only a human being tring to survive and not live in EXTREME pain all my life!!

  • ericaNovember 19, 2009 at 2:51 am

    My 8 month old son has just had surgery on his neck he had a hole that went right thru his neck that ended with a ciyst at the end after his surgery I was told I am only allowed to give him tylonal for his pain every 4 hours I read all this stuff and I wonder is this saft for me to be giving my son???

  • FrancisSeptember 24, 2009 at 9:38 pm

    Dianne, you should stick to truths to drive a point if you have one. -> There isn't a logical human alive who would believe that a Customer Service Representative, or anyone else for that matter, at McNeil Laboratories/Johnson & Johnson would state that any % death rate is acceptable. -> McNeil Laboratories/Johnson & Johnson gives kick backs to Doctors for prescribing Tylenol? By g[Show More]Dianne, you should stick to truths to drive a point if you have one. -> There isn't a logical human alive who would believe that a Customer Service Representative, or anyone else for that matter, at McNeil Laboratories/Johnson & Johnson would state that any % death rate is acceptable. -> McNeil Laboratories/Johnson & Johnson gives kick backs to Doctors for prescribing Tylenol? By giving them free pens, pads of paper, and a free dinner once per year? Further, Tylenol is predominantly an OTC (Over The Counter) medication. -> Of the non-narcotic pain relievers, Tylenol is the least likely to have negative drug interactions. -> You would be much more of an influential 'teacher' were you to display a grasp of the English language. Glenda: No, it hasn't any addictive properties. Perhaps she psychologically conditioned herself to take it or it worked well for her. I am a consumer. A normal everyday person, excepting for the fact that I suffer from CRPS. I couldn't get through any day were it not for acetaminophen. As an adult I accept the responsibility to use it as directed. As directed. It would behoove the consumer to read the Ibuprofen overdose side effects. Scary. Consumers take more than the stated dosage, experience complications, then blame the manufacturer. Situations such as this make me disgusted with my fellow Americans.

  • DonSeptember 13, 2009 at 8:35 am

    I had a relative who took acetominophen for many years for pain and still took it after being diagnosed with liver cancer. She died of liver cancer last year. She just wanted relief from her pain by taking acetominophen. I don't think she was addicted, though.

  • GlendaAugust 21, 2009 at 10:35 pm

    My mother died in 2005 after having been diagnosed with liver cancer; she took Tylenol almost daily for years to ease arthritis pain. I tried to get her to stop taking Tylenol so often, but she seemed to be hooked on it. I wonder is Tylenol addictive.

  • DianneJune 15, 2009 at 8:24 pm

    My nephew died after taking Extra-Strength Tylenol. They tried a liver and kidney transplant. It did not work. He was 29 years old! Nothing in his system except, Tylenol. I called the company years ago. They said 4% death was acceptable. I don't think his mother and Father believe that! I had a student that took several tylenol. Her liver shut down. but they were able to get her functioning. My[Show More]My nephew died after taking Extra-Strength Tylenol. They tried a liver and kidney transplant. It did not work. He was 29 years old! Nothing in his system except, Tylenol. I called the company years ago. They said 4% death was acceptable. I don't think his mother and Father believe that! I had a student that took several tylenol. Her liver shut down. but they were able to get her functioning. My son was in Romania, took a combination of the drug. Was in Hospital for months! He has never had a drink of Alcohol in his life! There should be a skull and cross bones on Tylenol. The only reason doctors perscribe it is because Tylenol gives bigger kick back. I wouldn't take it nor would my family. And two of my family are Doctors! You can jump-start a heart, you can't jump-start a liver. Take it of the Market!

  • BarbaraMay 29, 2009 at 5:25 pm

    I took Tylenol for my Rheumatoid pain for many years. I knew the liver could be damaged by overdose, This is the way I took care of my liver. Every so often I will use Chinese herbs instead of Tylenol to control pain.

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