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Acetaminophen Warning: FDA Adds Additional Concerns

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The FDA has announced a new warning Thursday for the manufacturers of acetaminophen, Tylenol, and similar medications. The official FDA consumer update warns consumers of the dangers of rare skin diseases associated with acetaminophen use, the symptoms of which include “rash, blisters and, in the worst case, widespread damage to the surface of skin.”

The link was discovered using the FDA’s medical literature and the Adverse Event Reporting System. 107 total cases of skin diseases linked to acetaminophen were found between 1969 and 2012; 67 of those were hospitalized and 12 died as a result. The FDA cites medical literature as having documented just over two dozen cases involving people of various ages.

The deputy director of the FDA’s Division of Anesthesia, Analgesia, and Addiction, Steven Hertz, M.D., said that the new warning labels are not intended to worry doctors or patients, merely that it’s “important that people recognize and react quickly to the initial symptoms of these rare but serious, side effects, which are potentially fatal.”

LiveScience notes that, unfortunately, there is no easy way of being able to tell who might suffer such an adverse reaction while taking the medication; on that subject, the FDA has said that the benefits of acetaminophen outweigh its risks.

Manufacturers of medicines that include acetaminophen as an ingredient are now required to warn their customers of Stevens-Johnson Syndrome, a reaction that ABC News notes is happening after the Supreme Court had an important ruling related to the drug company’s failure to warn her of the possibility she could contract a life-altering skin disease.

Although the FDA may come under criticism for choosing to sound the alarm over Stevens-Johnson syndrome, the decision comes two years after the FDA limited all prescription products to 325 mg/capsule. Dr. Hertz believes the risk is severe enough that doctors and patients should be made aware, and that the FDA’s decision should be examined in the context of the generations of people who have treated pain with acetaminophen.

Acetaminophen Warning: FDA Adds Additional Concerns


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  • Dan

    Tylenol no problem. And yet Marijuana is still illegal..

    • http://yahoo allen crigger

      thats our DA Goverment

    • Sara Grey

      @Dan, Marijuana is still illegal yet alcohol is readily available and killing people left and right. Makes sense? I don’t think so!

      • Sara

        Just to add another opinion to what I just posted. I worked in the emergency medical field for years and I would much rather be around a mellowed out pot smoker than a drunk any day! That doesn’t have anything to do with which is worse for you but just had to say it ..LOL

  • Josie

    Well, it has never bothered me, but that doesn’t mean that it won’t someday.

    • Jan

      Josie…
      I am allergic to many painkillers and have a couple of autoimmune diseases to contend with. I used Tylenol for around 2 – 3 years for any pain over and above what I couldn’t deal with. Two years ago, my liver tests showed a problem and my Dr. advised me to stop the Tylenol and I did. I no longer have a problem with my liver (if caught in time…a liver will regenerate itself.)

      • ivy

        @Josie thanks for sharing that piece of medical information. I had know idea that the liver would regenerate itself, if damage is caught in time. I guess the best thing though it to be proactive and steer away from drugs, at least long term that can cause any type of damage to a vital organ such as the liver.

        • ivy

          My comment was directed to Jan not Josie my mistake.

  • Jean

    Let’s see. That’s 2.49 cases per year over the last 43 years.

  • http://FACECRACK mAYHEM

    BLAH BLAH BLAH

  • Tina

    Acetaminophen also causes liver damage. Please be careful using it on a daily basis.

    • Ernie

      I took 6 Midol’s and 16 ibuprofen, surprisingly did not have liver damage. How the fuck do you explain that?!

    • http://yahoo allen crigger

      So true Tina

  • Iraida

    If Acetaminophen is dangerous than WHY do doctors tell you to take
    them? I was told to take for the inflammation on my knee. Now I have to see how much damage these pills did to my system.

    • john

      Acetaminophen is still safe to use for most people in moderation. A doctor can tell you to take them because he or she went to school to learn what is acceptable to use when and where. Of course if you get a side effect you should discontinue, but the side effects these warnings were added for are pretty darn rare.

    • Sara Grey

      Iraida, I can’t understand why your doctor would advise you to take acetaminophen for inflammation when it, in fact, is not an anti-inflammatory. Perhaps that should be a question to pose to your doctor.

    • Stephen W. Anderle

      Some doctors don’t pay very much attention to patients side effects, the number of drugs they are on, the amounts, and don’t keep as updated as they should. If you have any doubts go to a pain and drug specialist. With a complete list of everything you take ,when and what your symptoms are. Including time of day, before or after meal, bathroom etc. Including blood pressure readings, sore throat, coughing, irritability,weaknesses, itching, etc. Everything. Some doctors don’t watch for cross reactions. That’s what the specialists are for.

  • sheryl bryant

    I used it for years for pain. then my stomach started aching like an ulcer. the med. with the acetaminophen started to erode the lining of my stomach. the doc. said not to ever take it again. now I read the labels and make sure I don’t buy anything with that in it. I know everyones system is different. some tougher than others. I agree, why give or prescribe something that could hurt us. I use ibuprofen now, does not have (acet) in it and I am doing fine. also, though, I find I cannot eat some foods that I used to be able to eat. guess the old tummy got damaged.

    • T Jackson

      Hi Sheryl, you might want to be very careful with the ibuprofen as well as it is in a category with many others called non steroidal anti inflammatories or ‘nsaids’. This category of meds(ibuprofen,aleve,aspirin and more) can be the hardest on the stomache lining.In fact,I just healed from leaky gut after taking Aleve for only a few weeks. Not sure, but it sounds like you may have a mild case of leaky gut now, as when your lining becomes compromised it causes new food sensitivites until you heal up.You might want to be very careful what you eat for a while and avoid the nsaids for a bit as well if you can.

      Nsaids are known even more than acetaminophen for causing stomache problems. Its hard because I dont know what to take now either and have been taking tylenol only when pain is unbearable from cramps and such, but it seems none of these meds are really safe.There for a while I couldnt eat anything and had to go on a special leaky gut diet it was so bad. Anyways, glad your feeling a little better now though!

      • NC ALVAREZ

        anyone with digestive problems should look into probiotics,magnesium,himalayan salt solution called SOLE.also pine seed oil.look into DR MERCOLA AND SHIRLEYS WELLNESS CAFE WEBSITE FOR ANY STOMACH PROBLEMS.

    • Peggy Whited

      Sheryl, you have to be really careful with Ibuprofen. ALWAYS take with food and lots of liquid. It can cause bleeding in stomach and especially in intestines. It is also very hard on liver, and if used too much can cause kidney failure. I have bad arthritis, but try to not take ibuprofen every day. I’ve been trying naproxen (Aleve) but as it is also an NSAID (non-steroidal anti-inflammatory drug), all of them can cause internal bleeding. So I use as little as possible.

    • Jim

      I beg to differ on this one; not saying that you didn’t experience the problems that you described but it is very widely known in the medical community that ibuprofen poses a much greater risk of stomach lining damage & ulcer & upset stomach etc as compared to acetaminophen, which is much more widely known for causing liver problems not gastrointestinal problems. If you have stomach issues, I would be shocked if your doctor didn’t tell you to cut back on the ibuprofen.

  • poppi allen

    Too much will cause liver function decrease, but so will most all meds (or booze). Use all chemicals in moderation.

  • http://yahoo allen crigger

    Good old FDA and Why Now so what do I take I hate those B

  • jada

    wow.. ve been taking acetaminophen since i was twelve! I wonder hao much arm it has caused me

  • ivy

    All medications have both a therapeutic effect (desired effect) and side effect (non therapeutic effect). Medications should be used for the short term to achieve the therapeutic effect, and not the long term, that could cause side effects.

    The most important thing is to find out the source of the pain. There are many non pharmacological approaches to chronic pain. People from other countries don’t have a drug store on each corner. So they use natural painkillers.

    Accu puncture is more affordable and does not damage any vital organs. Life style changes including: dietary changes, stress relief measures, weight loss, use of herbal teas, meditation, exercise, all provide a non pharmacological approach to pain relief.

    The one thing this article left out, is alternatives to “acetaminophen, Tylenol, and similar medications.” In particular natural herbal remedies.

  • Pat

    Well wasn’t this a totally worthless report. What happens to the skin??? Where are the dang pictures showing what the skin looks like? A rash, sores, warts, bumps, crusty areas, or what….. To be informative and complete to WARN PEOPLE of DANGERS we need to know what the hell to look for on our on dang skin… Did I miss something? Yammering on about nothing…I do see rash and blisters and “wide spread damage” is the clincher… what???? let’s face it we are constantly reaching for something for a headache and we don’t take 1 or 2 tablets at a time anymore for some relief we are swallowing 4 and more tablets. We don’t think…. In the medical field doctors are pushing the hell out of pain relievers loaded with acetaminophen. All the codeines have it, Vicodin, Lortab, Norco, There are no safe pain relievers. And there are real situations for bad back surgeries and injuries and diseases like cancer in people’s ongoing lives that are necessary to get relief from pain. And there is nothing for them to take. And the other thing that pops up is “Opiate Itch” scratching your skin. I imagine this is what causes the rashes they are speaking about. Does the problem just show up or is it caused from itching. I am allergic to codeine. And I have a 8″ scar up my back from decompressions and cutting my discs lamedectomies. I am ruined for life hurting. This is how I know this stuff I am saying. I am sick of itching. And I was taken off of Lortab cause my liver did swell up. They call it fatty liver. It causes a bulge under your rib cage and it is so uncomfortable. There is no help no other avenues. I believe they left out the reason for the rash and the skin problems it is caused by itching.

    • Sara

      Pat, I too felt the article was a bit vague and I was waiting for the same information you were. Not only do we share that opinion, we also share the back issues. I feel for you. I decided to take the medicine that helps it and I rationalize it this way. If I don’t have a decent quality of life due to pain then why worry about what the medicine is doing? It goes back to the benefits outweigh the dangers. That is a personal decision though. Many people are allergic to codeine but can take hydrocodone which is a semi-synthetic opioid, that is derived from the natural opiates. So still an itchy opiate. Good luck with your back troubles.

  • Uncle Dave

    All medications and even most (if not all) foods have side effects. Its common sense people. So all of you blaming the FDC should get your heads out of the sand. It all goes back to the old adage of “anything in moderation wont hurt you.” We, as a people, must stop looking to blame someone or something else and take responsibility for our actions. Its not up to the government, religious organizations, or our next door neighbors to take care of everything for us. That’s our job!

    • ldean

      It’s not “common sense” as you put it. It’s medical sense and who among us are capable of diagnosing Stevens Johnson Syndrone. Ex-squeeze me; but I don’t know anybody who has a medical lab in their house, and a medical degree where they can run tests on all medications before actually taking them. Go away, troll.

  • morningfeather

    @ Pat…Google SJS if you want gory pictures, but maybe I can help you a little. When my daughter was 3, she had a rash on her back and belly. Little red dots, and she just felt blah. She had spend that Sunday with her dad and he said every time he picked her up, she cried. By the time I took her to the doctor the next morning he lifted her arm and ran his fingers down her side and her skin sloughed off. Before long, she had no skin… and the pain, the pain was horrible and I couldn’t even hold my own child. She would just hold her little head and bang it on the ground screaming “it hurts mommy, it hurts” I wanted to admit her to the hospital but they said that chicken pox and staph travel through the air and I would be signing her death certificate if they did. The only thing they gave her for the pain was Benadryl and let me tell you, it didn’t help. No one from the outside could enter our apartment and we only left for doctors appointments. I was scared to death! They gave her a 3% chance to live and if she did, she would be blind. We worked very hard to save her. It came back again when she was 10 and can return anytime in her life. She is 30 and is expecting her first child. Her SJS was one of two things, an attack of her own mucous membranes or Sulfa drugs. Someone always puts down the writer’s if these articles since it hasn’t happened to them or attacks the FDA on this site. I wish I has know years ago about taking too much acetaminophen – it would save me the pleasure of looking forward to what NASH is going to do to me. You can Google that too. Praying that SJS never touches anyone on your life… it is a game changer.

  • citizen

    For me it is a timely report. I took only one extra strength Tylenol, because of pain in my knee. And next day I had in the knee are one blister and rash and also on back of knee and then spreaded on other leg too. I never had this reaction in my life. So, I am not sure it was due to the medicine or some thing else.

  • ldean

    I’ve had a sloughing rash on the bottom of my feet for 8 years – cracking, bleeding. It’s mind boggling that layers of skin die off overnight, peel off in sheets and then regenerate almost immediately. I’ve been to 2 internists, 2 dermatologists, 2 ear/nose/throat (burning rash on tongue) with no diagnosis and a “learn to live with” response. Now, my eyes are inflamed, red and burn constantly. Dr. gives me $150.00 eye drops to treat the symptoms. I’m walking around on what feels like severely sun-burned feet and all the doctors treat me like a hypochondriac. I feel like if I ask them about this acedemediphen (sp – I KNOW) link, they’ll get mad at me for “reading something on the internet”… one doctor asked me where I got my medical degree from when I asked him to test me for SJS. I give up. The pain is so bad, I just hope I die an early death.

  • Elin Day

    I really take anything the FDA says with a huge grain of salt. Why? If the FDA is so concerned about the safety of medications, why don’t they pull the horrible Statin drugs off the market? People are prescribed these awful drugs with serious side effects, and I personally know two people that took Lipitor and Crestor and are now deceased from taking them.

    With any medication, there are side effects, including over-counter medications. I’ve taken Tylenol for years, without any side effects and I following the dosing instructions on the label.

  • Stephen W. Anderle

    Also watch out for ACE inhibitors, the blood pressure drugs. They can cause rebound and end raising your blood really high. Norvasc seems really bad about that. Apparently too , some people only need to take them for a while till whatever caused the blood pressure to go up is corrected, cancer, or even a bad bout of Flu. Or reactions to other drugs. My Mother was on blood pressure drugs for one year after breast cancer surgery, then quit taking it. no problems for thirty years.

  • Oracle3

    Most of the problems are with heavy drinkers who ignorantly use Tylenol to ward of the inevitable headache. Most are women and may are on the liver transplant list.

  • Terrie

    My daughter had this several times and it was the most horrific thing I we have ever been through. She nearly died each time and she had the blisters in her lungs, mouth, throat and eyes as well as covering her entire body. She still has scars. I never thought that this was the cause but it makes sense because she would start out with a simple cold or a fever and I would give her Tylenol and within a day she was in the hospital with SJS.

  • cccourt

    Wait, wait? Are they saying acetominophen CAUSES SJS? How can any scientist relate 12 deaths over a 43 year period to this drug? I don’t understand the proof of a connection. Think how many people in the WORLD have taken Tylenol and 12 have died of a link between this compound and SJS?

    • Gwen Lynch

      SJS/TENS… LOOK IT UP PEOPLE !!! MY SON HAS HAD IT 4 TIMES. MOST DON’T DIE BUT WILL LIVE WITH THE DAMAGES IT CAUSES ALL THEIR LIFE. HE CAN NOT TAKE ANY KIND OF MEDS WHAT SO EVER. DUE SJS/TENS. WE HAVE SPENT WEEKS IN HOSP AND HOME CARE. THE REPORT IS WRONG. MORE AND MORE PEOPLE ARE GETTING SJS/TENS. MOST DOCTORS ARE NOT AWARD OF THIS AND THEY DON’T KNOW WHAT THEY ARE LOOKING AT. THERE IS REALLY NO TEST OF SJS/TENS.

  • Art

    Acetaminaphin is a very dangerous drug. An overdose which can be as little as 20 pills can cause severe liver and kidney damage and ev3en be fatal. In the U.K. it is the drug of choice for suicide and the government restricts packaging to no more than 24 pills. it is especially dangerous as has been mentioned above with alcohol use. Drink even a moderate amount of alcohol, pop a few Tylenol for the headache and the next thing you know you’ve blitzed your liver. I might add that the FDA has pulled less dangerous drugs off the market.

  • LisaRN

    107 in, what, 44 years? VERY rare. People need to be more worried about hearing and liver damage. Most have no idea how many things (cough medicines like Nyquil for instance, and many cold rememdies) Acetaminophen is in. There have been cases of deafness and people destroying their livers by taking more than 4000mg a day of acetaminophen over a long period of time. So if you see someone popping Tylenol and swigging cough medicine from the bottle, be less worried about them falling asleep, and more about the long-term damage they are doing to these organs.

  • ESTELLA DAVIS

    manufacturers of acetamenaphen and ibuprophen have been warring for years over the safety of the two drugs. we are caught up in the war. the rash is probably from the stress of the war and not from the drug itself. my doctor recommends acetamenaphen in safe dosages for me personally. the wars continue in any case. consult with your physician about the safety of any drugs and the value versus the side effects of the drugs. estella m davis.

  • Regie

    That is one drug I never allowed in my home as well as inform friends and family how dangerous that stuff is. Why they allow it on the shelves makes no sense.It is responsible for 40% of Europeans liver failures per year.Yet they still take it and the USA barely warns the consumer how bad that stuff is. I knew a guy who use to pop a handful at a time for hangovers. It crystallizes in your liver and your done.He died at 39 years of age. Just a normal average weekend warrior.His death certificate even stated acetaminophen poisoning.Since the bottle does have small print warning these companies profit without fear of law suit.Those bottle should have a siren on em when you pick em up off the shelf.

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