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.

72 comments
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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.

Asadali
Asadali

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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.

JoePeters
JoePeters

I stopped taking Acetaminophen (Tylenol) over 5 years ago. Wont touch the stuff. Neither should you if you want to keep your liver for a lengthy period.

alienstarship
alienstarship

Here we go again another scare the people so we can take away your drugs, what a bunch of crap, I guess people should not drive because someone may die from an accident and better not eat food because someone may get sick and die. These people who come out with this junk are trouble maker's and they have nothing better to do. Who funds these research test with who's money??

ZukenRedac
ZukenRedac

What if we have 500 and 725 doses should we ask for anew prescription then

SteveBowlus
SteveBowlus

"  ... 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."  The answer to this question is in the statistics: 107 cases in over 40 years.  So ... maybe three cases a year? and one fatality every three or four years?

What is the spontaneous rate of these conditions?  Are they _caused_ by a drug interaction, or are they _associated_ with taking the drug?

I'm going to really lose sleep over this.

macbookpro7547
macbookpro7547

Typical liberal scare article , most painrelivers can cause deadly reactions . This is just another scare by the media to increase regulation on drugs, most people at risk are those who rely on stupid FDA rules to stay safe. Research drugs that you want to use on your own, and get regular check ups to determine if you are allergic and at risk. Much better than wasting tax payer money and scareing people who want to use these drugs.

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.  

thetitaniumdragon
thetitaniumdragon

@JoePeters Everything is dangerous. Your odds of dying from taking acetaminophen are far less than your odds of dying from, say, driving.

JoePeters
JoePeters

@ZukenRedac 

 You should stop taking Acet at all and take IBU or aspirin instead, if you can.

thetitaniumdragon
thetitaniumdragon

@macbookpro7547 As the article itself points out, the purpose is to get people to recognize the symptoms and go to the hospital before their skin starts falling off.

The problem is that many people are morons and have no real understanding of what this warning means.

To scientists and engineers, it is just an acceptable risk. To a moron with no sense of scale, it is dangerous.

misterzellers
misterzellers

@macbookpro7547 Geezus, turn OFF the Rush Limpballs and jump-start those objective, critical-thinking skills, for Christ's sake. This is just embarrassing what today's political right have become. So say "thanks", liberals; mindless drones like this are among your best allies at the polling place...

notLostInSpace
notLostInSpace

@macbookpro7547 Lets go back to the 1800's when any scammer could make up any toxic brew, claim great effects ("cancer goes away", "pounds melt away", "look younger") and totally get away with it.    What I really have a problem with is your advice:  "research drugs"....uh, most of us do not really have the knowledge or resources to do that.....get regular check ups, many of us do not have that resource either.  Moreover, my doctor doesn't look under every nook and cranny to find out if Tylenol is killing me.  Your advice would result in doctors being over whelmed with requests for toxic tests on all sorts of things.  You talk the great Republican game, who needs the FDA, NIH, EPA, they just cost money right?  We have probably the best regulators that have ever existed and the right wing would love to destroy that, so the pharmas can go literally unregulated. 

kevin.flynn56
kevin.flynn56

@macbookpro7547Liberal scare tactics? Is that anything like Conservatives claims on WMD's, Yellow Cake uranium, or Iraq's nuclear capacities and Mushroom clouds over America?

n.k.h.73908513321516
n.k.h.73908513321516

@macbookpro7547 Yes, it is always best not to tell people what might go wrong.  Everyone should be doing regular academic research to find possible signs of bad reactions to over the counter medications, but we need to keep this information away from the evil regulators who might try to regulate medications with bad reactions.

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!

SteveBowlus
SteveBowlus

Good to know ... and just reinforces my comment.

I'm much more concerned with the rather narrow therapeutic window of the drug, which has potential to affect most (ab)users through (reversible?) liver damage.

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.

thetitaniumdragon
thetitaniumdragon

@SteveBowlus Well, the truth is that we kind of just expect people to be responsible for themselves. We have to really; we can't babysit everyone.

Everything we consume is dangerous if consumed in sufficient quantity. Drugs are dangerous if you abuse them, don't take them according to directions, or deliberately overdose on them, but they allow some drugs (like acetaminophen) to be given out without a prescription simply because it is convenient, they are relatively safe, and frankly, given how many other things we sell people which are probably far more dangerous, restricting acetaminophen is probably a bit silly. Bleach and ammonia are both readily available, for instance, and misusing them can result in bad times (mixing the two, for instance, results in toxic gasses, and both can damage your skin if you expose yourself to them).

The goal of the warning is more or less to raise awareness. Sadly some people will panic over it.

Acetaminophen, like many drugs, can indeed cause kidney and liver damage, but if you use it according to the recommendations, it is very unlikely. It becomes somewhat more likely if you have preexisting liver damage - heavy drinkers are more likely to suffer liver damage from taking it, for instance, which is why there's actually a warning on most of the bottles I've seen not to take it with alcohol.

In the end it is a matter of calculated risk - your odds of suffering harm from it, versus the benefit of feeling less bad. Personally, I have a genetic resistance to many common painkillers (my grandfather had the same), and as such I don't take them because they don't do anything for me. I do take other forms of over the counter medication which sometimes contain acetaminophen, for instance various congestion medications, but that is primarily because of the other chemicals in there which do help me.

The way I figure it, the risk is very low, so if the benefit is significant, then it is worthwhile.

Remember, driving a mile in your car has a 1.5 in 100 million chance of killing you via a fatal car accident. If you drive 5 miles to and from work per day, you're taking a 1.5 in 10 million chance of dying every day. When you put it in that perspective, the odds of having a 1 in 4 million reaction to medication isn't so bad.

Everything is dangerous, in the end, but some risks are so marginal as to be practically nonexistent.