Acetaminophen Linked to Fatal Skin Reactions

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Acetaminophen is one of the most widely used medicines for fever and pain, commonly found in drugs like in Tylenol. On Thursday, the Food and Drug Administration (FDA) announced that acetaminophen is causing rare, but dangerous skin reactions in some people.

The popular pain-killing medication is linked to three skin diseases with symptoms that range from rash and blisters to more extensive damage to tissues under the skin. The two most serious skin conditions are Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), which will typically require hospitalization and can be fatal. The less dangerous skin disease is acute generalized exanthematous pustulosis (AGEP), which usually resolves itself within two weeks once acetaminophen is stopped.

Many of the reactions start with flu-like symptoms of fever and muscle aches, which are followed by rash, blistering and sloughing off of the outside of the skin, which can expose patients to potentially fatal infections. It’s possible for victims to experience scarring, skin pigment changes, blindness and organ damage. The recovery can take weeks or months. The FDA says anyone who is taking acetaminophen and is experiencing skin symptoms, should stop taking it immediately.

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“This new information is not intended to worry consumers or health care professionals, nor is it meant to encourage them to choose other medications. However, it is extremely important that people recognize and react quickly to the initial symptoms of these rare but serious, side effects, which are potentially fatal,” said Dr. Sharon Hertz, the deputy director of FDA’s Division of Anesthesia, Analgesia and Addiction in a statement.

The FDA says it will require manufacturers to add warning labels to all prescription medications that contain acetaminophen and will work with makers of the over-the-counter drugs to do the same. The FDA discovered the risk of skin diseases while reviewing adverse events reported in its database between 1969 and 2012, during which 107 cases of significant skin reactions were reported, 67 people were hospitalized and 12 people died.

It’s not clear why the skin conditions have not emerged as a health concern sooner, given how many people take the pain-killing medication. Health officials say it’s too soon to determine whether does is an issue, or whether the combination of acetaminophen with other ingredients or medications causes the adverse events. Often, such side effects only become apparent once a drug reaches market and is used by millions of patients, since manufacturers cannot anticipate every potential interaction between their product and others. For example, some statins, which lower cholesterol and reduce inflammation, were discovered to raise the risk of diabetes and other painkillers known as Cox-2 inhibitors were linked to an increased risk of heart attack and stroke.

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The announcement isn’t the first to alert users to the potential harms of acetaminophen. Two years ago, the FDA limited prescription acetaminophen doses to 325 milligrams per tablet or capsule to prevent liver injury. For now, the FDA says people using the drug should not stop the medication unless they develop skin symptoms. The side effects are rare, and for most users, the agency says the benefits of the drug outweigh its risks.

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TT1976
TT1976

OMG.This has been the first article that comes close to what I have experienced. When I was younger I took Tylenol just like everyone else in the world...rarely needed it but useful when needed. Since  I went into the Army(19yes old)  I have become highly allergic to Tylenol. I my skin turnsvery  red and bubbly (hives I guess) , its hot internally and externally, cant breathe  and itches to high heaven! I even got out of speeding ticket going to ER once cop saw me . Because I was a healthy and active soldier (and too young at the time to mention or think about it) it took a couple years to figure out what I was having an reaction too..but BINGO eventually put 2 & 2 together ,,each time I had taken Tylenol I hd to go ER (despise hospitals and only in 18 yrs have Ive ever been in ER other then this was after I broke my hand and it took me 3 days to go). Once the military physicians realized the common factor they did more tests and stated to me...at a certain (unfortunately they are not able to tell me ..thats Army doctors for you) dosage within the recommended amount and time-frame my body rejects it. I have been told by many doctors though-out the years (17 yrs living with this now) this is a rare and dangerous allergy.

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LindaMC
LindaMC

Yes good old FDA always watching out for us, they approved the GMO's they force on us. Why am I not surprised? Glad I never used Tylenol, it never did anything for me when I did try it. 

bachcole
bachcole

Wow, what a big surprise!  A negative side affect of a pharmaceutical drug.  Who would have guessed?  I don't suppose that any of you people who worship at the altar of modern medicine have noticed that just about every pharmaceutical drug has negative side affects and that NO pharmaceutical drug actually makes you healthier.  And yet these are the only substances allowed in the religion of modern medicine.  Natural substances need not apply.

And the kicker is that ALL pain relievers mask the problem that you should be trying to heal.


silverchild57
silverchild57

I have never found Tylenol to be the lest bit effective in eliminating pain, so I don't use it. My sister died of Stevens-Johnson Syndrome in 1974, at the age of 27. I wonder if Tylenol was the cause.

pathologist
pathologist

I am a practicing, academic pathologist with specialty training in both liver and skin pathology.  I have subspecialty Board training in dermatopathology. I wouldn't stop taking acetominophen for fear of Stevens Johnson/erythema multiforme because it's much too rare.  However, I stopped taking acetaminophen years ago because of the potentially lethal effects it has on the liver.  I've seen too many people pop one too many of these pills thinking it's really safe and develop fulminant hepatic failure leading to transplant and death.  This most often happens in children (because their caregivers give them too much to get fevers down) and in adults who drink alcohol.  Even if you are a social/moderate drinker, acetaminophen is not processed normally and is toxic to hepatocytes (liver cells).  For pain and fevers, my family uses ibuprofen.  If you must use tylenol, then alternating doses of ibuprofen and acetaminophen is recommended.

paulhoward9993
paulhoward9993

All of us have different body chemistries that effect how we process medication.  In a large population like the US,  there isn't a drug at the supermarket that isn't going to effect somebody adversely.  A warning label that there is a .005% chance of some adverse reaction is going to save a life?     Really.........

morning2024
morning2024

Wonder if this has any connection with the aluminum they keep spraying in the skies and this could be making these people more susceptible? More and more people are becoming allergic to medications that they have had no problem with in the past.

Percussionist
Percussionist

' Health officials say it’s too soon to determine whether does is an issue'... it should read dose. I understand editing can be a 'pain', especially in an article on acetaminophen but no excuses.



morningfeather13
morningfeather13

Everyone of you arguing over something silly like should there be a warning label for such a rare side effect. When you can't hold your 3 year old daughter in your arms to give her comfort because she has no skin and is in extreme pain, then come back with your silly argument. Until then, count yourself blessed that is hasn't touched your family as it has others in this forum. It is a horrible and helpless thing to watch a loved one go through. 


Ksassy44
Ksassy44

I sincerely question that this only happens with acetaminophen?  This exact thing happened to me in Feb. 2005 while taking Ibuprophen.  I woke one morning and had tiny blisters all over my face and under my chin; they itched.  The next day all the blisters burst, leaving my skin like sand paper.  Going into the doctor he gave me something to counteract that; he had no idea other than I became allergic to Ibuprophen.  Scared me!  What a way for a face peel?

GetReal123
GetReal123

Any death is tragic. 12 in 43 years. The debate should be about the 200k + deaths each year in the U.S. from prescribed medication.

chaokai60
chaokai60

From the paragraph it could be inferred that people using the drug should not stop the medication unless some fatal skin diseases were developed, which condition was discovered in the FDA database that in the 107 reported cases, 67 people were hospitalized and 12 people died.

aliberaldoseofskepticism
aliberaldoseofskepticism

@bachcole LOL You do realize, of course, that aspirin is basically salicylic acid, right? And that is derived from what? Salix nigra; if you live in eastern North America, you've seen S. nigra around. The big difference is that in pill form, you might get too little (and thus no effect other than a placebo) or too much (and thus side effects, in salicylic acid's case, internal bleeding).

LindaMC
LindaMC

@pathologist  I find Excedrin does a very good job, I have migraine headaches and nothing ever worked tp get rid of them  and Excedrin did. Now I take migraine medication, thank God they have it now. 

bachcole
bachcole

@pathologist   Modern medicine works against the body to suppress any inconvenient symptom; this is one reason why pharmaceutical drugs have so many negative side affects, including lethal side affects.  Natural healing works with the body, so there are next to no negative side affects and lots of positive side affects.

ATPMSD
ATPMSD

@pathologist

Please explain in more detail, ibuprofen is an NSAID and these are not good for the liver, so much so that doctors recommend only short term use of such medications and instead recommend the use of Tylenol

paulhoward9993
paulhoward9993

@morningfeather13  


So, if there was a label on tylenol warning that there is a 1 in a million chance of an adverse reaction,  you  would have not given your  3 year old daughter the medicine?   Really...........i'm not buying it.  

aliberaldoseofskepticism
aliberaldoseofskepticism

@bachcole @pathologist Actually, homeopathic medicine and "naturopathic" medicine focus on symptoms. Hell, Hahnemann's first rule was "simila similibus curantur", or anything that causes the symptom can cure it. How is that NOT focusing on the symptom?

The second rule of homeopathic medicine is the law of infinitesimals, that is, distilling it to the point that no amount of the active ingredient is left.

All of this because Hahnemann himself had a bad result from cinchona bark. Quinine is derived from cinchona bark, and Hahnemann took some and it gave him chills and fatigue. Homeopathic medicine is based entirely on his egotistical belief that his personal reaction explains not only cinchona, but all medicine!

bachcole
bachcole

Aliberaldoseofskepticism,  homeopathy uses symptoms to get at the cause, which is the person's own inability to correct the symptoms their healing power has generated or allowed to happen.

Whether Hahnemann was egotistical or not is irrelevant to the fact that homeopathy works, even if NO physical substance is left.  I know all about Avogadro's number.  I can ever pronounce it and spell it.  My belief is that homeopathy is magic, and I don't mean that poetically.  I mean it literally.  Materialism does not disprove homeopathy; homeopathy disproves materialism.