Tylenol No Longer Deemed a Pain Reliever for Babies & Toddlers

An FDA panel recommended “pain relief” be removed from the label of Tylenol for babies and toddlers due to lack of evidence that it relieves pain at this age.

The FDA’s Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee have together recommended that “pain relief” be removed from the label of Tylenol for babies and toddlers and other brands of acetaminophen* because there is no reliable evidence that it relieves pain better than placebo in children under age two.

This will surprise many parents who reach for these common pain relief drops when their little ones are teething or have an earache or a sore throat. Not surprisingly, the over-the-counter drug industry trade group (CHPA) objects to the findings of the expert panel.

Tylenol Does Reduce Fever – But Why?

The advisory panel recommended that the acetaminophen label should say it’s for “fever reduction” and nothing else. But here’s the thing – in most cases the fever is helping the child by activating the immune system and fighting the infection. I don’t routinely recommend treating a typical fever unless it is interfering with a child’s ability to sleep or to drink liquids (both are even more important for healing than the fever). If the fever is high or prolonged, it is wise to consult with a physician.

If we don’t give acetaminophen to babies and toddlers for pain, and we rarely give it for fever – this will change the landscape of over-the-counter medications for young children.

Tylenol Is Not As Benign As Many People Think

Acetaminophen is the most common cause of acute liver failure in the US. It has been estimated to cause three times as many cases of liver failure as all other drugs combined. While the serious problems usually come from overdoses, in babies and small children the dose that can cause harm may be not many times more than the recommended dose.

Tylenol Dosing Should Be Based on Weight

Most dosage charts that parents see list a dose based on age, or suggest that parents ask a doctor for the dose. And dosage concentrations have varied in various formulations. Together, this confusion has led to overdosing and to fatalities in several dozen healthy young children over the last decade.

The FDA panel has recommended that all liquid acetaminophen come in the same concentration, that all packages contain dosing information for children down to 6 months of age, and that the dose be based on the child’s weight.

Powerful Recommendations

I applaud these recommendations and hope they will be formally adopted by the FDA. If so, I expect they will result in safer children. As parents we don’t have to wait, though, to change our own practices.

2015 Update: Why Did This Post Go Viral Four Years After the Fact?

As many of our readers have pointed out, this isn’t new news. The joint meeting of the FDA Advisory Committee for Nonprescription Drugs and the FDA Pediatric Advisory Committee took place on May 17th and 18th 2011. I wrote this article on May 18th. In March of 2015, someone on Facebook found this post and began to share it, even though the post had not been updated for four years. This took us by surprise, but pointed out the Tylenol for babies and toddlers is still an important topic to parents of young children.

What Happened in 2011

The dozen or so manufacturers of acetaminophen were unable to point to evidence that convinced the doctors, nurses, pharmacists, and patient advocates present at the joint FDA Advisory Committee and Pediatric Advisory Committee meeting that oral, OTC-strength acetaminophen relieves pain in children 6 months to 2 years old. The experts reviewed all 10 studies that addressed this question and concluded there was no compelling evidence for pain relief (unlike fever reduction, which is clear cut). You can read the entire FDA panel transcript here [as of June 15, 2018, the transcript is no longer on the FDA web site, but the archive copy is available]. They often used the word analgesia, which is a medical word for pain relief.

It appears to have been a spirited discussion. At the hearing, the Director of Pain Medicine at Seattle Children’s Hospital said, for example,

“it would be a horrendous disservice to young children to label this product as having any kind of analgesic effects because I think that if we assume that it does, and people are walking around giving acetaminophen to children thinking it’s analgesic and it’s not, you’re going to have a lot of children stuffing pain that should not be.”

“So I would argue extremely strongly that unless there are data to convince us that this product is analgesic in young children, that that should not only not be on the label but should be made extremely clear to the public and professionals alike that the analgesic effects of acetaminophen in younger children have not been shown.” (page 106)

But despite their strong decision, it was never made extremely clear to the public or to professionals that pain relief for younger children had not been shown. (Though this little post has certainly been passed around recently!)

At the FDA meeting, the experts on the panel pointed out that we get it wrong about 20% of the time when we extrapolate that because something works in older kids or adults it will also work in babies or toddlers. Babies’ livers (for instance) function differently than older kids’.

Susan Baker, Professor of Pediatrics at Women and Children’s Hospital gave a great example of this. Doctors used to commonly give reflux medications to colicky babies because many of these babies have reflux, the medications (PPIs) work in older children, and the babies are clearly in pain. Doctors thought they worked for babies; parents thought they worked – but the FDA used a ‘cattle prod’ to make the manufacturers do studies to show they really worked, better than just waiting, because these drugs also had side effects. Turned out – babies’ reflux is different and the meds didn’t work at all.

Here’s what Dr. Baker said:

“I would like to point out that this was the situation with PPIs before the FDA took that on. Every baby was put on PPIs in high doses because they were all perceived to be in pain. When you demanded that appropriate studies be done, they were done by almost every manufacturer of PPIs, and my group participated in every one of them. And in fact, they did zip, zero, nothing. They did absolutely nothing. We could say why didn’t we just simply extrapolate that data down to babies and then continue to use it as we have been?”

“But because of the very good data that we were able to obtain, because you used a cattle prod, we know that that was worthless, and perhaps we saved babies from being on PPIs for an indeterminate period of time. We know that PPIs are a risk factor for a C. diff, and so on.”

“We don’t know a lot of that stuff about acetaminophen right now. And I think that we need to step up to the plate…”

 Acetaminophen Manufacturer’s Response

Unsurprisingly, the manufacturers were not pleased with the decision of the advisory groups and wasted no time in speaking up. They also voluntarily agreed to change the concentrations on their new labels to make them consistent, instead of different concentrations for different ages, to reduce overdose (a major problem). When the FDA made its decision on the new labels, they chose to disregard the recommendations of their advisory groups about pain relief. This is not unusual. They weigh many issues in their larger deliberations, not just the findings of the physicians, nurses, pain specialists, pharmacists, and patient advocates.

Where does that leave us today?

Pain relief on the label is unchanged for children under age 2.

The latest major scientific reviews of pain medications in infants I can find today were published in 2014. We are perhaps better now at measuring pain in babies, using validated combinations of heart rate, oxygen levels, blood pressure, as well as facial expressions, cries, and sometimes hormone levels.

We do know and have known that oral acetaminophen relieves pain in older children and adults. But the studies looking for pain relief from oral acetaminophen in babies have been disappointing. (For instance, in babies getting a heel prick, there was no discernible difference between babies who got or didn’t get oral acetaminophen). But heel prick pain is different than teething pain, which is different than an earache.

The thing about kids less than two years old is that it’s a pivotal time of development – so much so that there is an important emerging area of science called the Developmental Origins of Health and Disease (DOHaD). A combination of maternal and environmental factors early in life can have a long-term effect on health. Because acetaminophen is one of the most widely used medications at that age, because we know acetaminophen is a powerful drug, and because we know so little about the effects at that age (having not even shown pain relief), to me it seems an important area for research – or at least not to cover over the questions.

I’m not saying oral acetaminophen doesn’t work – I’m saying we don’t know enough. And we should. Babies’ pain is important. Which questions to study and how to study them is a great discussion to have.

Parents Report that Tylenol Works as Pain Relief for Their Babies & Toddlers

In the comments below, you’ll see that many parents and nurses report that they use Tylenol (acetaminophen) for their babies and toddlers and it works for them. That experience is compelling. I still think it’s sad that when it comes to commonly used medicines in infants and toddlers that the effects have often not been well-studied.

Wouldn’t it be great if parents’ experience of clinical observation and of changes in vital signs – and the experience of thousands of others – were collected and explored, since the medicine is being given anyway. We could learn so much about the timing of effect, for instance, which might be very different in babies than in older kids.

With medical-grade sensors becoming far less expensive and far more available, I’m looking forward to parents being able to get better answers to lots of questions. One person doing this is powerful (and can answer the question for a particular child). With lots of us doing it we could learn so much so quickly!

When ResearchKit was released by Apple two weeks ago, it was able to do in only 24 hours what would typically take 50 medical centers a year to do – recruit 10,000 people into a medical study.

These 2011 FDA Advisory Committees had all the available medical literature available to them in trying to answer their question – but there was very little data, gathered over many years, involving very few children, with mediocre results at best – so they had little choice but to say there’s not enough evidence to conclude that acetaminophen relieves pain in kids 6 month to 2 years.

If 10,000 parents measured objective criteria, we could know in a day.

What If We Found Tylenol Was Effective Pain Relief for Babies & Toddlers?

The next question would be, if it works, is it the acetaminophen in Tylenol (the ‘active ingredient’) or is it another ingredient (such as the high fructose corn syrup and other sweeteners) or a combination of the ingredients. We know more about the power of sugar than acetaminophen to relieve pain in babies

FYI: The ‘inactive’ ingredients in Cherry-Flavored Infant’s Tylenol include: anhydrous citric acid, butylparaben, FD&C red no. 40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, and xanthan gum.

Various types of ‘sugar water’ have been shown to significantly relieve pain in babies. Also, there are large studies showing that coal-based FD&C dyes can affect behavior. The sorbitol and sucralose might play a role. There’d still a lot to sort out – but we could do it.

Major Concerns

Tylenol (acetaminophen) can be very safe at the right dose, but it deserves respect. Acetaminophen is responsible for more overdoses, and overdose deaths [the original report is no longer on the —– site, but as of June 15, 2018 you can read the archive report here] than any other drug product.

Acetaminophen poisoning was responsible for [the original report is no longer available, but as of June 15, 2018 you can read the archived report here]:

  • 56,000 ER visits
  • 26,000 hospitalizations
  • 458 deaths

Those aren’t big numbers for 28 billion doses given in the US, but every one is important when it’s your child.

In addition, too much acetaminophen is the single biggest cause of acute liver failure in US. Some studies suggest acetaminophen can cause asthma, I’m not convinced about that yet.

Who’s Fault is Acetaminophen Overdose?

The drug manufacturers suggest dosing errors are parents’ faults.

Thankfully in 2011, the FDA Committees voted for standardized liquid dosing. But many parents aren’t aware that acetaminophen is an ingredient in over 600 different easy to buy over-the-counter medicines that are used to relieve symptoms including in medicines labeled as pain relievers, fever reducers, sleep aids, cough, cold and allergy management. Using these medicines in combination can lead to accidental overdose — even when parent think they are within the correct limits.

Tylenol for Fever in Babies & Toddlers

At the 2011 joint FDA meeting, they discussed acetaminophen to reduce fever in babies and toddlers. On page 6 of the minutes of the FDA Advisory Committees[the original report is no longer on the —– site, but as of June 15, 2018 you can read archive copy here], it says that the committees agree that acetaminophen is effective at reducing fever in kids under 2.

Keep in mind, often fevers help kids to heal and are better untreated.

Personally, I use Tylenol (acetaminophen) often, confidently, but thoughtfully. This is the approach I recommend for my patients as well.

Resources:

*FDA Advisory Committee Meeting Minutes [Last accessed on the FDA site April 1, 2015. Available here as of June 15, 2018.]

FDA Meeting Transcript: Day One [Last Accessed on the FDA site on March 30, 2015. Available here as of June 15, 2018.]

FDA Meeting Transcript: Day Two [Last Accessed on the FDA site on March 30, 2015. Available here as of June 15, 2018.]

OTC Industry Supports FDA Advisory Committee Recommendations on New Dosing Instructions. May 18, 2011.

Lee WM. “Drug-Induced Hepatotoxicity.” New England Journal of Medicine, July 31, 2003, 349:474-485

“Pain management in newborns.” Clinics in perinatology. yr:2014 vol:41 iss:4 pg:895

“Neonatal pain.” Paediatric anaesthesia. yr:2014 vol:24 iss:1 pg:39

This American Life: “Use Only As Directed” Act 2: Babies [Last accessed June 15, 2018.]

We’ve known much of this for over a decade:

PERSONAL HEALTH; With Tylenol and Children, Overdosing Is Perilously Easy

Last medical review on: April 01, 2015
About the Author
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Dr. Greene is a practicing physician, author, national and international TEDx speaker, and global health advocate. He is a graduate of Princeton University and University of California San Francisco.
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Recent Comments

You’re concerned about your child’s health yet you let someone carve up his genitals?
Disgusting, besides not making any sense. What is wrong with Americans and their desire to not be held responsible for hurting their own children?

Hi Kristen,

Thanks for alerting us to the broken links to the FDA site. We’ve updated the article with links to the archived version.

Also, be sure to check the section of the article “2015 Update: Why Did This Post Go Viral Four Years After the Fact?” There is a major point of clarification that I think you’ll find very helpful.

Best,@MsGreene
Note: I am the co-founder of DrGreene.com, but I am not Dr. Greene and I am not a doctor. Please keep that in mind when reading my comments and replies.

The 2 FDA citations don’t work, and the one that did cited that pain reliever SHOULD be included on the label. Which is it? The article notes it’s not for pain, just fevers but the citation article suggests differently.

Hi Kristen,

Thanks for alerting us to the broken links to the FDA site. We’ve updated the article with links to the archived version.

Also, be sure to check the section of the article “2015 Update: Why Did This Post Go Viral Four Years After the Fact?” There is a major point of clarification that I think you’ll find very helpful.

Best,@MsGreene
Note: I am the co-founder of DrGreene.com, but I am not Dr. Greene and I am not a doctor. Please keep that in mind when reading my comments and replies.

I agree…If it works, don’t mess with it…My children as well as my grandchildren were raised on Baby Tylenol, Children Tylenol and Tylenol for adults. I now have a great-grandbaby that I sit with everyday while the mother works and the baby is teething. Baby Tylenol works for her teething pain as it did with my others! All have grown up healthy with zero complications…I know for a fact that Baby Tylenol works…I understand that all babies/children matter, however, the few that do react to tylenol in the populus should be using something else or the parent should pay more attention to the doses their child is receiving. In medicine, there is no such thing as “one size fits all”.

I agree that it’s an important area for *further* research. I don’t think mothers should feel guilty for using it if it shows improvement in their experiences with their children. Even in the articles I’ve read – including this one – in light of the “controversy” the big part that sticks out to me is the FDA’s opinion is based on removing “analgesic effects” from the label because there is not enough research to support that it has a strong affect in children under two. But how many trials have actually been committed for the sake of evaluating pain relief for that age group? Yes, this article mentions a heel test, but it even spoke to the difference of teething pain vs prick pain, they are different pains.

I feel that the real problem is that since this age group (under 2) is the biggest user of acetaminophen, and yes it is a powerful drug, and yes there have been devastating cases of overdosing and their consequences, instead of banishing the idea that acetaminophen provides pain relief, why not educate parents on a better usage system rather than to scare them away from the product all together?

I feel more confident using Tylenol now that the label has removed dosage for under the age of two – it means a conversation with my child’s pediatrician, who knows my child, and will give me accurate dosage. I happily had the hospital administer Tylenol for my son’s circ just like I happily gave him Tylenol (based on his weight) before minor oral surgery and following the surgery for management. I happily give him a dose before vaccines and a dose (in the proper waiting period) afterwards – to manage the muscle soreness.

With our son’s surgery, our experience was that we thought he was fine and skipped a day – he was miserable. So we gave him Tylenol again, and he was happy again. That speaks to me that Tylenol helped to manage my son’s pain. We stopped after day 4, and he was fine so we discontinued the use of Tylenol while continuing Hyland’s teething gel and coconut oil for local discomfort due to the stretches for the site. But IF a mother has had a positive experience with Tylenol for their child, I don’t think they should feel guilty – just that they should be educated in the dosage for their child’s weight to prevent overdosing and its consequences. As that is the heart of the issue – all the negative aftermath of misuse of the product.

All opinion. It just upset me when a nurse in the hospital told me I gave my son jaundice because I had them administer the Tylenol for the circ when he clearly passed his riboflavin test and when I showed up panicking at the doctor she dissolved my worries – no jaundice. It’s being brought up in a support group that Tylenol is evil and whereas it may not work on every child – as every drug has a different reaction in different bodies – I don’t think bashing Tylenol users is helpful to a mother who just wants the best for their child, especially if they’ve witnessed improvement firsthand.

You’re concerned about your child’s health yet you let someone carve up his genitals?
Disgusting, besides not making any sense. What is wrong with Americans and their desire to not be held responsible for hurting their own children?

More and more research is coming out linking acetaminophen to asthma, ADHD and autism. Acetaminophen may be the link between autism and vaccines, since from the mid-1990s parents were advised to give their babies acetaminophen before and after vaccinations for pain and fever relief. Research on this area is being conducted, and every six months or so a new article emerges.

See:

As a mom with an autistic son, who both took tylenol during my pregnancy and gave it to him before and after his vaccines, I am very concerned by the research so far….

Hi Kristin. Thanks for your great comments! And excellent question.

Most studies I’ve seen on the pain-relieving effects of acetaminophen will say something along the lines of “The exact mechanism is undefined.” But finally that is changing.

There seem to be several pathways involved. Most are agreed that acetaminophen is a COX inhibitor, which in the brain changes the serotonin pathways. Plus it seems to affect the brain’s endorphin pathways. Plus it may directly block NMDA receptors. And it may work peripherally as well. (And each of these pathways may mature at different points).

Here’s a good review article from Pediatric Pharmacotherapy with links to individual studies – but I only know where to find it on Medscape: http://www.medscape.com/viewarticle/742445_2

A 2015 study (epub ahead of print) explains the latest thinking in greater detail – and again points to the working together of multiple pathways (http://www.ncbi.nlm.nih.gov/pubmed/25732401 – the full article is much more informative than the abstract).

The idea that acetaminophen works just by raising the pain threshold did hold sway for decades:

Analgesic-antipyretics and anti-inflammatory agents. In: The Pharmacologic Basis of Therapeutics. Pergamon Press; 1985

Narcotic and non-narcotic analgesics which block visceral pain evoked by intra-arterial injection of bradykinin and other analgesic agents. Arch Intern Pharmacodyn Ther. 149:571-588; 1964

Site of action of narcotic and non-narcotic analgesics determined by blocking bradykinin-evoked visceral pain. Arch Intern Pharmacodyn. 152:25-58; 1964

And this thinking can still be found in online drug resources: http://www.rxlist.com/tylenol-drug/clinical-pharmacology.htm.

But the current thinking, Kristin, is that raising the pain threshold is only one piece of a much more complicated, multi-piece puzzle in older children and in adults. But we don’t know what, if anything, it does to relieve pain in kids under two.

Dr Greene, Can you verify if there are scientific studies that verify the comment left by “Momma” that tylenol works in a unique way that it doesn’t releive pain, but that it increases pain tolerance? I’ve never heard that throughout my time in med school, and I’m very interested in this subject.

Hi Kristin. Thanks for your great comments! And excellent question.

Most studies I’ve seen on the pain-relieving effects of acetaminophen will say something along the lines of “The exact mechanism is undefined.” But finally that is changing.

There seem to be several pathways involved. Most are agreed that acetaminophen is a COX inhibitor, which in the brain changes the serotonin pathways. Plus it seems to affect the brain’s endorphin pathways. Plus it may directly block NMDA receptors. And it may work peripherally as well. (And each of these pathways may mature at different points).

Here’s a good review article from Pediatric Pharmacotherapy with links to individual studies – but I only know where to find it on Medscape: http://www.medscape.com/viewarticle/742445_2

A 2015 study (epub ahead of print) explains the latest thinking in greater detail – and again points to the working together of multiple pathways (http://www.ncbi.nlm.nih.gov/pubmed/25732401 – the full article is much more informative than the abstract).

The idea that acetaminophen works just by raising the pain threshold did hold sway for decades:

Analgesic-antipyretics and anti-inflammatory agents. In: The Pharmacologic Basis of Therapeutics. Pergamon Press; 1985

Narcotic and non-narcotic analgesics which block visceral pain evoked by intra-arterial injection of bradykinin and other analgesic agents. Arch Intern Pharmacodyn Ther. 149:571-588; 1964

Site of action of narcotic and non-narcotic analgesics determined by blocking bradykinin-evoked visceral pain. Arch Intern Pharmacodyn. 152:25-58; 1964

And this thinking can still be found in online drug resources: http://www.rxlist.com/tylenol-drug/clinical-pharmacology.htm.

But the current thinking, Kristin, is that raising the pain threshold is only one piece of a much more complicated, multi-piece puzzle in older children and in adults. But we don’t know what, if anything, it does to relieve pain in kids under two.

What is more important and more worhty of studies than our most vulnerable population? Babies under two. As Dr Greene stated, the first two years is a pivotal time of development and for that reason babies respond differently than older children and adults to the same medicines. Medicine given intravenously works faster and often more efficiently because the liver doesnt have to metabolize it first, so no; It is absolutely not the same, and its not a logical deduction that the two work the same. Tylenol has a high rate of causing liver toxicity and acute liver failure, especially in babies.

You’re not taking advice from the Internet, your taking advice from a doctor and an FDA advisory committee made up of other doctors that just happens to be available to you on the Internet. I think its part of human nature to cling to old ideas and bad science.

Whats going on is called SCIENCE.

At the FDA meeting, they pointed out that we get it wrong about 20% of the time when we extrapolate that because something works in older kids or adults it will also work in babies or toddlers. Babies’ livers (for instance) function differently than older kids’.

Susan Baker, Professor of Pediatrics at Women and Children’s Hospital gave a great example of this. Doctors used to commonly give reflux medications to colicky babies because many of these babies have reflux, the medications (PPIs) work in older children, and the babies are clearly in pain. Doctors thought they worked for babies; parents thought they worked – but the FDA used a ‘cattle prod’ to make the manufacturers do studies to show they really worked, better than just waiting, because these drugs also had side effects. Turned out – babies’ reflux is different and the meds didn’t work at all.

Here’s what Dr. Baker said:

“I would like to point out that this was the situation with PPIs before the FDA took that on. Every baby was put on PPIs in high doses because they were all perceived to be in pain. When you demanded that appropriate studies be done, they were done by almost every manufacturer of PPIs, and my group participated in every one of them. And in fact, they did zip, zero, nothing. They did absolutely nothing. We could say why didn’t we just simply extrapolate that data down to babies and then continue to use it as we have been?”

“But because of the very good data that we were able to obtain, because you used a cattle prod, we know that that was worthless, and perhaps we saved babies from being on PPIs for an indeterminate period of time. We know that PPIs are a risk factor for a C. diff, and so on.”

“We don’t know a lot of that stuff about acetaminophen right now. And I think that we need to step up to the plate…”

You go Pam !

I noticed that as well

Tylenol is intended for use in low grade fevers. The Tylenol/motrin combo is way more effective for higher fevers. Motrin/advil/ibprophen are all better in my opinion. Not because of their ability to work or not work better but because they’re not as rough on babies little organs.

Yes! Couldn’t have said it better myself…

The instructions should be changed. However, I don’t believe changing the labeling on the bottle will result in parents not using Tylenol for pain. I also don’t believe it should be changed. Tylenol works very well on my 5 month old when it’s needed. She was a preemie due to my development of eclampsia at 7 months pregnant. She was 4 lbs at birth and due to her prematurity will be smaller then most infants for a while. This is why I think the instructions should be changed to a weight chart vs. Age recommendations. She’s my first child so I was terrified to give her Tylenol the first time bc of some reading i have done on the dangers of infant Tylenol. . . Anyway, I had to call her pediatrician first. My point is, not everyone has a nurse or pediatrician on call 24/7. I feel it should state that a pediatrician should be consulted before the FIRST USE of any pain/fever reducer then there should be a weight chart recommendation as instruction for use. Sorry, but as you can see, I feel this is a serious matter. Babies can die bc of wrong measurements. . . I’m surprised this hasn’t been changed sooner, quite frankly.

i both agree and disagree with this article. My 6yo son has some pretty severe disabilities. We’ve had both encounters of medical staff at hospitals overdosing my kiddo to the point of septic renal failure, and when Tylenol is used correctly, it’s saved his life ample times from preventing febrile seizures from temp spikes ( staggered advil and Tylenol) I don’t find Tylenol to be as affective as advil for pain, BUT!! There are certain components in Tylenol that cannot be given to all kids based on medical Dx’s, just as well as other meds… This is a hit and miss article in my eyes, but as a mother living through a nightmare caused by “too much” of an admin I do understand

Thanks for your well-reasoned comment! The thing about kids less than two years old is that it’s a pivotal time of development – to the extent that there is an important emerging area of science called the Developmental Origins of Health and Disease (DOHaD). A combination of maternal and environmental factors early in life can have a longterm effect on health. Because acetaminophen is one of the most widely used medications at that age, because we know acetaminophen is a powerful drug, and because we know so little about the effects at that age (having not even shown pain relief), to me it seems an important area for research – or at least not to cover over the questions.

Which questions to study and how to study them is a great discussion to have – and thank you so much for raising it!

I have to say also I dont agree ..Tylenol was a factor in rrducing fever and pain in my children growing up and it worked it still works and you need not change it ..wat are u all tryin to do ? This is ridiculous to me adds to the list of Governmental population control..Im frankly pissed you change something that works to this day..makes one wonder what the hell is goin on

I agree…If it works, don’t mess with it…My children as well as my grandchildren were raised on Baby Tylenol, Children Tylenol and Tylenol for adults. I now have a great-grandbaby that I sit with everyday while the mother works and the baby is teething. Baby Tylenol works for her teething pain as it did with my others! All have grown up healthy with zero complications…I know for a fact that Baby Tylenol works…I understand that all babies/children matter, however, the few that do react to tylenol in the populus should be using something else or the parent should pay more attention to the doses their child is receiving. In medicine, there is no such thing as “one size fits all”.

Whats going on is called SCIENCE.

How exactly is an infant suppose to tell you that the medication is relieving their pain if their physical response isn’t good enough? I have 3 kids and I have witnessed all 3 start to feel better after taking Tylenol especially when they have fevers. All this “scientific evidence” is getting out of hand. Everyday “Science” claims we are doing something wrong yet the majority of kids are healthy and your article didn’t mention which illness were studied while tylenol was being given. So many issues with these studies. I plan to continue to give my children Tylenol and I am sure their pediatrician would tell me not to take advice from the internet.

You’re not taking advice from the Internet, your taking advice from a doctor and an FDA advisory committee made up of other doctors that just happens to be available to you on the Internet. I think its part of human nature to cling to old ideas and bad science.

You go Pam !

It would seem tragic to me to waste millions of dollars to spend money on clinical research studies investigating whether or not oral acetaminophen is effective for the population less than 2 years old. If we conclude that intravenous acetaminophen is effective, and believe that oral acetaminophen is absorbed into the bloodstream (which we can infer from its impact on fever reduction), then it would logically follow that oral acetaminophen was be effective for this patient population. As the FDA panel suggests, there is a lack of high quality studies in this patient category, but lack of evidence of benefit does not mean evidence for lack of benefit. The FDA seems to have made a responsible decision to leave pain relief on the label (in my opinion). We have a limited amount of research funds in this country, and I sincerely hope that we choose to fund more worthy clinical questions than the one you raised with your blog post. I hope parents continue to give acetaminophen, especially in neonates and infants, as it is most likely safer than an alternative medication (ibuprofen) or not medicating at all.

What is more important and more worhty of studies than our most vulnerable population? Babies under two. As Dr Greene stated, the first two years is a pivotal time of development and for that reason babies respond differently than older children and adults to the same medicines. Medicine given intravenously works faster and often more efficiently because the liver doesnt have to metabolize it first, so no; It is absolutely not the same, and its not a logical deduction that the two work the same. Tylenol has a high rate of causing liver toxicity and acute liver failure, especially in babies.

Yes! Couldn’t have said it better myself…

Thanks for your well-reasoned comment! The thing about kids less than two years old is that it’s a pivotal time of development – to the extent that there is an important emerging area of science called the Developmental Origins of Health and Disease (DOHaD). A combination of maternal and environmental factors early in life can have a longterm effect on health. Because acetaminophen is one of the most widely used medications at that age, because we know acetaminophen is a powerful drug, and because we know so little about the effects at that age (having not even shown pain relief), to me it seems an important area for research – or at least not to cover over the questions.

Which questions to study and how to study them is a great discussion to have – and thank you so much for raising it!

Tylenol never worked for my son either he is 18 months old and the only thing that worked for him was motrin (ibprofen)

Kristina, thanks for your comment!

The experience of a nurse and a mother is valuable indeed. Your routine experience is compelling. I still think it’s sad that when it comes to commonly used medicines in infants and toddlers that the effects have often not been well-studied. Wouldn’t it be great if your experience of clinical observation and of changes in vital signs – and the experience of thousands of other nurses – were collected and explored, since the medicine is being given anyway. We could learn so much about the timing of effect, for instance, which might be very different in babies than in older kids.

I’ll edit the article to incorporate your suggestion of being specific that I’m not talking here about very high fevers. Thanks again!

I usually love your blog, but I’m not in love with this article.

My son basically had an ear infection for the first two years of his life. I regularly gave Tylenol, the dye-free variety more often than not, and I can tell you with absolute certainty that it relieved his pain. I routinely witnessed a transition from cranky and inconsolable to calmer and more relaxed after administering. I’m a nurse, so I also pay attention to things like respirations and heart rates, and those too were reduced.

My biggest issue with this article, however, is this statement: “I don’t recommend treating fever unless it is interfering with a child’s ability to sleep or to drink liquids (both are even more important for healing than the fever).” This is fine if you’re referring to a low grade fever, but you don’t specify that. Fevers that get too high and last too long cause protein denaturation and thus organ damage (namely brain damage). No one should be replacing their physicians advice with information gleamed from a blog, but that doesn’t change the fact that people listen to you.

Kristina, thanks for your comment!

The experience of a nurse and a mother is valuable indeed. Your routine experience is compelling. I still think it’s sad that when it comes to commonly used medicines in infants and toddlers that the effects have often not been well-studied. Wouldn’t it be great if your experience of clinical observation and of changes in vital signs – and the experience of thousands of other nurses – were collected and explored, since the medicine is being given anyway. We could learn so much about the timing of effect, for instance, which might be very different in babies than in older kids.

I’ll edit the article to incorporate your suggestion of being specific that I’m not talking here about very high fevers. Thanks again!

I agree whole heartedly. I wish I could like that multiple times. I worked wonders for ear aches here. But, I as far as the Google thing. I’m glad you have a smart doctor. Mine has went all “organic” and refuses to give dosing information for Tylenol under age 4 without seeing them. He gets $80 for each visit and I get a dose amount (not to count time off work). And, ibuprofen hurts one of my kid’s stomach (ulcer). So I have to “Google” dosage for Tylenol. Leave the darn dosing labels on the bottle. And leave the “pain reliever” on it too. If it doesn’t work for one kid doesn’t mean it won’t work for the other.

This studies are dumb and I am sick of all this. We have been given Tylenol to my 8 month old and it works for him. It helps his mouth and with the discomfort he gets with having fluid build up in his ear. All this crap does is try to make parents question all they do and stuff. I will continue giving my kids this because it does work. You cannot believe everything you read. But I do trust my kids doctor because he is more knowledgeable then Google.

I agree whole heartedly. I wish I could like that multiple times. I worked wonders for ear aches here. But, I as far as the Google thing. I’m glad you have a smart doctor. Mine has went all “organic” and refuses to give dosing information for Tylenol under age 4 without seeing them. He gets $80 for each visit and I get a dose amount (not to count time off work). And, ibuprofen hurts one of my kid’s stomach (ulcer). So I have to “Google” dosage for Tylenol. Leave the darn dosing labels on the bottle. And leave the “pain reliever” on it too. If it doesn’t work for one kid doesn’t mean it won’t work for the other.

You did read the article right?? Where it says that Tylenol does reduce fever. They may be wrongly stating it doesn’t work for pain but as for fever… it does yours may have been expired. And Tylenol isn’t acually a pain reliever. Anyone who works in the medical field will tell you that Tylenol acually works in a unique way unlike most medications. It does NOT relieve pain but acually increases a persons pain tolerance. And a fever is NOT good for a child or anyone. Yes it is a sign that your body is fighting off an infection but the fever itself is not good for you.

When you don’t treat a high fever kids stay sicker, longer. They get weak, won’t eat or drink, and end up in longer recovery time. Treat the fever, rest better, eat better, drink fluids equals getting well faster. I have seen this time and time again with my 3 children.

You’re actually not supposed to put your children in a Luke warm or cold bath/shower when they have a fever. Ur drops the body temperature way too fast and can cause the child to go into shock. You should apply cold compresses under the armputs and on the groin area. ~Someone with experience in the nursing field

you could have just put your baby in a temped bath so the fever would break.

You’re actually not supposed to put your children in a Luke warm or cold bath/shower when they have a fever. Ur drops the body temperature way too fast and can cause the child to go into shock. You should apply cold compresses under the armputs and on the groin area. ~Someone with experience in the nursing field

“Autism starts in utero, due to the changes in the brain seen” – hence the article I saw in the ASHA journal. It may not happen for all but may be a trigger.

Never said that “Tylenol causes autism”…I wondered about a connection between the two.

Miranda, that would be exciting!

The wonderful Linda Avey, who was the co-founder of 23andMe, the world’s first personal genetics company, is now working working on a cool new project called We Are Curious (www.wearecurio.us) – a platform that will soon help people agree on questions and put them to the test.

Nor is there a reason for Temp>104. It takes temps over 107 to cause harm. And, fever control does not prevent febrile seizures.

Your husband’s uncle must have had encephalitis or meningitis. Typical febrile seizures don’t cause brain damage. There are genetic conditions that cause brain abnormalities and seizures with fever, as well. This is quite different from a typical febrile seizure.

Great points, Kath! Usually medicines that work for older children and adults do work for younger children and babies – and vice versa. But not always.

The question of whether they could just extrapolate from what we know from older kids and adults was discussed at length in those meetings. They pointed out that in the 375 or so cases where they had formed opinions based on extrapolation, they ended up changing their mind 20 percent of the time when they got more data to fill in the blanks. That would be more than 70 drugs that did NOT work as expected from other age groups.

In the latest 2014 reviews of pain relief in babies, we are still relying on extrapolation for many uses of oral acetaminophen.

My preference is for parents to understand a general idea of what we know and what we don’t: We do know it relieves pain in adults and older kids. We do know that IV acetaminophen can work even in newborns and even for surgical pain. But the studies for pain relief in babies from oral acetaminophen have been far more disappointing than I think most parents would guess – though not conclusive either way.

I don’t object to parents trying it.

Like you, I’ve seen very happy babies when given for teething. I think there are more effective choices for ear pain.

Whether pain relief is on the label or not wouldn’t affect whether parents could give it – it would just prevent companies from over-promising unproven benefits.

Our goal is the same – keeping kids as happy and healthy as possible (and parents as rested and healthy as we can!).

Oragel has benzocaine, which can cause methemoglobinemia (chocolate blood). If you use this, use the smallest possible amount, if any at all.

While true, acetyl salicylic acid (aspirin) can cause Reye’s disease. We don’t see this devastating illness much anymore since the use of aspirin was greatly curtailed in the early 80’s.

It is not the fever that causes the discomfort, it is the illness. The hottest kids on the planet have Roseola. They are typically 104-105+, yet they aren’t all that uncomfortable. The child feels better when you give them a pain reliever, regardless of whether the fever drops.

When you don’t treat a high fever kids stay sicker, longer. They get weak, won’t eat or drink, and end up in longer recovery time. Treat the fever, rest better, eat better, drink fluids equals getting well faster. I have seen this time and time again with my 3 children.

It takes temperatures above 107, if not higher to cause any brain injury. This only happens in a child with a significant themperature control problem. My kids didn’t have fevers that weren’t 105F. I didn’t give them anything. The myth that fever causes brain injury just won’t die. As Dr. Serwint of Johns Hopkins says, ‘Fever is a part of the body’s well orchestrated response to infection.’

Hi Nicole. Thanks. As you point out this joint meeting of the FDA Advisory Committee for Nonprescription Drugs and the the FDA Pediatric Advisory Committee took place on May 17th and 18th 2011. I wrote this article later on May 18th. The dozen or so manufacturers of acetaminophen were unable to point to evidence that convinced the doctors, nurses, pharmacists, and patient advocates present that oral, OTC-strength acetaminophen relieves pain in children 6 months to 2 years old. The experts reviewed all 10 studies that addressed this question and concluded there was no compelling evidence for pain relief (unlike fever reduction, which is clear cut). They often used the word analgesia, which is a medical word for pain relief.

You can read the whole FDA transcript here on the FDA site: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCommittee/UCM264149.pdf

It appears to have been a spirited discussion. At the hearing, the Director of Pain Medicine at Seattle Children’s Hospital said, for example, “it would be a horrendous disservice to young children to label this product as having any kind of analgesic effects because I think that if we assume that it does, and people are walking around giving acetaminophen to children thinking it’s analgesic and it’s not, you’re going to have a lot of children stuffing pain that should not be.”

“So I would argue extremely strongly that unless there are data to convince us that this product is analgesic in young children, that that should not only not be on the label but should be made extremely clear to the public and professionals alike that the analgesic effects of acetaminophen in younger children have not been shown.” (page 106)

But despite their strong decision, it was never made extremely clear to the public or to professionals that pain relief for younger children had not been shown. (Though this little post has certainly been passed around recently!)

Unsurprisingly, the manufacturers were not pleased with the decision of the advisory groups and wasted no time in speaking up. They also voluntarily agreed to change the concentrations on their new labels to make them consistent, instead of different concentrations for different ages, to reduce overdose (a major problem). When the FDA made it’s decision on the new labels, they chose to disregard the recommendations of their advisory groups about pain relief. This is not unusual. They weigh many issues in their larger deliberations, not just the findings of the physicians, nurses, pain specialists, pharmacists, and patient advocates.

Where does that leave us today?

Pain relief on the label is unchanged for children under 2.

The latest major scientific reviews of pain medications in infants I can find today were published in 2014. We are perhaps better now at measuring pain in babies, using validated combinations of heart rate, oxygen levels, blood pressure, as well as facial expressions, cries, and sometimes hormone levels.

We do know and have known that oral acetaminophen relieves pain in older children and adults. And that IV acetaminophen works for babies and toddlers. But the studies looking for pain relief from oral acetaminophen in babies have been disappointing. (For instance, in babies getting a heel prick, there was no discernible difference between babies who got or didn’t get oral acetaminophen). But heel prick pain is different than teething pain, which is different than an earache.

I’m not saying it doesn’t work – I’m saying we don’t know enough. And we should. Babies’ pain is important.

Thanks again, Nicole.

1) Pain management in newborns. Clinics in perinatology. yr:2014 vol:41 iss:4 pg:895
2) Neonatal pain. Paediatric anaesthesia. yr:2014 vol:24 iss:1 pg:39

My son is almost 2 years old. Now that I think about it Tylenol did not work for my son. When he was 6 months old he had sudden fever during a day, so I called my doctor. He says give Tylenol every 4 hours. I gave it to him, still was having fever all day and evening until my doctor told me to add Motrin to it. So Motrin every 6 hour tylenol every 4 hours at the end he started vomiting. Fever still high 101. I don’t believe tylenol works. He only ended up vomiting 4 times and the fever stopped after midnight. Ever since we sticking with Motrin. So its different on every baby I guess, but thank you for the information.

Tylenol is intended for use in low grade fevers. The Tylenol/motrin combo is way more effective for higher fevers. Motrin/advil/ibprophen are all better in my opinion. Not because of their ability to work or not work better but because they’re not as rough on babies little organs.

Tylenol never worked for my son either he is 18 months old and the only thing that worked for him was motrin (ibprofen)

You did read the article right?? Where it says that Tylenol does reduce fever. They may be wrongly stating it doesn’t work for pain but as for fever… it does yours may have been expired. And Tylenol isn’t acually a pain reliever. Anyone who works in the medical field will tell you that Tylenol acually works in a unique way unlike most medications. It does NOT relieve pain but acually increases a persons pain tolerance. And a fever is NOT good for a child or anyone. Yes it is a sign that your body is fighting off an infection but the fever itself is not good for you.

you could have just put your baby in a temped bath so the fever would break.

Interesting that you mention about the high fructose corn syrup. When my brother was a baby in the 70s we had a neighbor with teenagers who swore by red sucker for teething. I remember my mom rubbing that sucker on my brother’s gums and him calming down. I mentioned it to my daughter’s pediatrician in the early 2000s and she said “it’s probably the sugar”. We used Hyland’s teething tablets and had great results with that so I never bothered with sucker. But the doctor didn’t dismiss it as implausible or just an old wive’s tale.

Miranda,
I have to agree with you every time I took my daughter in to get shots I give her Tylonal the one time I didn’t give her Tylonal she was up all night in so much pain I had to finally go to a 24 hour wallgreens and get her some Tylonal and within 30 min of her taking it she calmed down and went to sleep

I totally agree, JJ. My argument exactly!

Miranda, I’m with you. I don’t agree with this article AT ALL (sorry Dr. Greene). If Tylenol works for children & adults, then why wouldn’t baby Tylenol with the same active ingredient work for babies/infants? We have used dye free and Tylenol brand, BOTH seem to help my baby with teething pain and sleep better. We don’t give it often, but when we do it’s because nothing else works. Even though my testimony isn’t data or “reliable evidence”, it shouldn’t discredit that Tylenol (or other brands) works.

This article was written prematurely in my opinion. Until there is substantial research done & data collected, I don’t think this recommendation should be taken seriously.

Great points, Kath! Usually medicines that work for older children and adults do work for younger children and babies – and vice versa. But not always.

The question of whether they could just extrapolate from what we know from older kids and adults was discussed at length in those meetings. They pointed out that in the 375 or so cases where they had formed opinions based on extrapolation, they ended up changing their mind 20 percent of the time when they got more data to fill in the blanks. That would be more than 70 drugs that did NOT work as expected from other age groups.

In the latest 2014 reviews of pain relief in babies, we are still relying on extrapolation for many uses of oral acetaminophen.

My preference is for parents to understand a general idea of what we know and what we don’t: We do know it relieves pain in adults and older kids. We do know that IV acetaminophen can work even in newborns and even for surgical pain. But the studies for pain relief in babies from oral acetaminophen have been far more disappointing than I think most parents would guess – though not conclusive either way.

I don’t object to parents trying it.

Like you, I’ve seen very happy babies when given for teething. I think there are more effective choices for ear pain.

Whether pain relief is on the label or not wouldn’t affect whether parents could give it – it would just prevent companies from over-promising unproven benefits.

Our goal is the same – keeping kids as happy and healthy as possible (and parents as rested and healthy as we can!).

Leonard, What combination of oils do you use to reduce fevers in toddlers and infants? AND how do you use them…topically? Orally?

Thank you for responding so quickly. Just wanted to add that we always used the dye-free tylenol (usually generic). I just looked up the ingredients and it has no high fructose corn syrup. My son has a g-tube so dye-free was better for us. Also, there are thousands children/babies out there hooked up to pulse ox probs just like my son. And many of them have home care nursing that document well. There is no reason that this information couldn’t be used to aquire data.

Miranda, that would be exciting!

The wonderful Linda Avey, who was the co-founder of 23andMe, the world’s first personal genetics company, is now working working on a cool new project called We Are Curious (www.wearecurio.us) – a platform that will soon help people agree on questions and put them to the test.

Miranda,
I have to agree with you every time I took my daughter in to get shots I give her Tylonal the one time I didn’t give her Tylonal she was up all night in so much pain I had to finally go to a 24 hour wallgreens and get her some Tylonal and within 30 min of her taking it she calmed down and went to sleep

Miranda, I’m with you. I don’t agree with this article AT ALL (sorry Dr. Greene). If Tylenol works for children & adults, then why wouldn’t baby Tylenol with the same active ingredient work for babies/infants? We have used dye free and Tylenol brand, BOTH seem to help my baby with teething pain and sleep better. We don’t give it often, but when we do it’s because nothing else works. Even though my testimony isn’t data or “reliable evidence”, it shouldn’t discredit that Tylenol (or other brands) works.

This article was written prematurely in my opinion. Until there is substantial research done & data collected, I don’t think this recommendation should be taken seriously.

Miranda – that’s nice evidence indeed. And I like the way you think!

With medical-grade sensors becoming far less expensive and far more available, I’m looking forward to parents being able to get better answers to lots of questions. One person doing this is powerful (and can answer the question for your particular child). With lots of us doing it we could learn so much so quickly!

When ResearchKit was released by Apple two weeks ago, it was able to do in only 24 hours what would typically take 50 medical centers a year to do – recruit 10,000 people into a medical study.

These FDA Advisory Committees had all the available medical literature available to them in trying to answer their question – but there was very little data, gathered over many years, involving very few children, with mediocre results at best – so they had little choice but to say there’s not enough evidence to conclude that acetaminophen relieves pain in kids 6 month to 2 years.

If 10,000 parents did what you did, we could know in a day.

The next question would be, if it works, is it the acetaminophen in Tylenol (the ‘active ingredient’) or is it another ingredient (such as the high fructose corn syrup) or a combination of the ingredients.

FYI: The ‘inactive’ ingredients in Cherry-Flavored Infant’s Tylenol include: anhydrous citric acid, butylparaben, FD&C red no. 40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, and xanthan gum.

Various types of ‘sugar water’ have been shown to significantly relieve pain in babies. Also, there are large studies showing that coal-based FD&C dyes can affect behavior. The sorbitol and sucralose might play a role. There’d still a lot to sort out – but we could do it.

Dr Greene, Can you verify if there are scientific studies that verify the comment left by “Momma” that tylenol works in a unique way that it doesn’t releive pain, but that it increases pain tolerance? I’ve never heard that throughout my time in med school, and I’m very interested in this subject.

Interesting that you mention about the high fructose corn syrup. When my brother was a baby in the 70s we had a neighbor with teenagers who swore by red sucker for teething. I remember my mom rubbing that sucker on my brother’s gums and him calming down. I mentioned it to my daughter’s pediatrician in the early 2000s and she said “it’s probably the sugar”. We used Hyland’s teething tablets and had great results with that so I never bothered with sucker. But the doctor didn’t dismiss it as implausible or just an old wive’s tale.

Thank you for responding so quickly. Just wanted to add that we always used the dye-free tylenol (usually generic). I just looked up the ingredients and it has no high fructose corn syrup. My son has a g-tube so dye-free was better for us. Also, there are thousands children/babies out there hooked up to pulse ox probs just like my son. And many of them have home care nursing that document well. There is no reason that this information couldn’t be used to aquire data.