FDA Will Issue Notice to Doctors Linking Acetaminophen Use During Pregnancy to Autism
It turns out, a study recently published by researchers from the Harvard School of Public Health suggests using acetaminophen during pregnancy may increase children’s autism and ADHD risk.
A few weeks ago, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. vowed to find the cause of rising autism cases by this September.
Apparently, a possible cause is the use of the pain-reliever acetaminophen (the active ingredient in Tylenol). President Donald J. Trump and his team now indicate that the Food and Drug Administration (FDA) will issue a notice to doctors shortly that the use of Tylenol during pregnancy may be linked to an increased risk of autism.
In a press conference at the White House, President Donald Trump said the Food and Drug Administration will begin notifying physicians immediately that it is “strongly recommending that women limit Tylenol use during pregnancy unless medically necessary.”
“They are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary,” Trump said. “That’s, for instance, in cases of extremely high fever.”
Studies on this question have not shown a direct cause and effect. Some studies point to a possible link, but major medical groups have evaluated the evidence and continue to recommend acetaminophen as the safest painkiller during pregnancy.
The press has been quick to dismiss the potential links by citing “experts” and their claims that acetaminophen is the safest pain reliever to use in pregnancy. A review of the headlines offered by the elite press claims there are “unproven links,” “decades of evidence,” and “claims not backed by science.”
Reuters went so far as to quote the maker of Tylenol, assuring everyone that it was safe to use during pregnancy.
“We believe independent, sound science clearly shows that taking acetaminophen does not cause autism. We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers,” Kenvue, the maker of Tylenol, said in a statement ahead of the announcement.
Shares of Kenvue (KVUE.N), opens new tab slid more than 7% during Monday’s stock market session as investors braced for Trump’s announcement. But the shares recovered 5% in extended trade.
The mainstream press and the Big Pharma advocates in the media and government are about to get a lesson on how meaningless their claims are in the post-COVID era.
Let’s review some of the “mixed” findings for a few moments, which seem to indicate there is a potential for a link.
To begin with, a major systematic review led by Harvard T.H. Chan School of Public Health and the Icahn School of Medicine at Mount Sinai analyzed 46 studies, finding that 27 studies reported significant links between prenatal acetaminophen exposure and neurodevelopmental disorders, including autism and ADHD. In contrast, nine found no link and four indicated protective effects. The review applied the Navigation Guide, a gold-standard methodology for environmental health research.
Results: We identified 46 studies for inclusion in our analysis. Of these, 27 studies reported positive associations (significant links to NDDs [neurodevelopment disorders]), 9 showed null associations (no significant link), and 4 indicated negative associations (protective effects). Higher-quality studies were more likely to show positive associations. Overall, the majority of the studies reported positive associations of prenatal acetaminophen use with ADHD [attention-deficit/hyperactivity disorder], ASD [autism spectrum disorder], or NDDs in offspring, with risk-of-bias and strength-of-evidence ratings informing the overall synthesis.
Conclusions: Our analyses using the Navigation Guide thus support evidence consistent with an association between acetaminophen exposure during pregnancy and increased incidence of NDDs. Appropriate and immediate steps should be taken to advise pregnant women to limit acetaminophen consumption to protect their offspring’s neurodevelopment.
The authors called for caution and further research, recommending judicious use under medical supervision.
While the study does not show that acetaminophen directly causes neurodevelopmental disorders, the research team’s findings strengthen the evidence for a connection and raise concerns about current clinical practices.
The researchers call for cautious, time-limited use of acetaminophen during pregnancy under medical supervision; updated clinical guidelines to better balance the benefits and risks; and further research to confirm these findings and identify safer alternatives for managing pain and fever in expectant mothers.
“Pregnant women should not stop taking medication without consulting their doctors,” Dr. Prada emphasized. “Untreated pain or fever can also harm the baby. Our study highlights the importance of discussing the safest approach with health care providers and considering non-drug options whenever possible.”
This review, published in August of this year, clearly supports the direction the FDA is headed: ensuring that both doctors and their potential patients are well-informed about the data and fully aware of the implications when making drug-use decisions.
Or, are we not to believe the experts at the Harvard School of Public Health or Mt. Sinai simply because the maker of Tylenol says it’s safe to use during pregnancy?
The anti-Trump, anti-RFK, GOP-hate antics of the press are hurting our country in countless ways. Failure to present all the information, including the recent findings from obviously credible scientists, means that expectant mothers are not getting complete information based on high-quality analysis. The news coverage on this announcement provides even more reasons to distrust our press, and we already had plenty based on its shameful coverage of the COVID-19 pandemic.
I will simply note that this new study probably managed to finally see the light of day because silencing data counter to preferred Big Pharma narratives is no longer occurring.
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The concern is not new and was not just dreamed up by Trump and RFK,Jr. Here is a link to a study done in 2022. It likely is one of those reviewed by Harvard School of Public Health authors.
A Systematic Review of the Link Between Autism Spectrum Disorder and Acetaminophen: A Mystery to Resolve
https://pmc.ncbi.nlm.nih.gov/articles/PMC9385573/
What has to be kept in mind is all studies are not equal just because they are good studies. For example this is an example of a decent study that found children of mothers who took acetaminophen are more likely and because it is a quality study it was rightly included
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0272593
However from the study itself
“We used data from the First Baby Study, a prospective cohort study conducted in Pennsylvania, USA, with 2,423 mother-child pairs.”
On the other hand this Swedish study from 2024 was of 2.5 million children
https://www.nih.gov/news-events/news-releases/study-reveals-no-causal-link-between-neurodevelopmental-disorders-acetaminophen-exposure-before-birth
This one is supports a link with data of 73,881
The point I am making is all studies are not equal with both the largest (by far) and most recent (because the most recent is also the largest) one suggesting there is no link.
My problem with the Swedish study is they depended on the The Swedish Prescribed Drug Register which contains data on prescribed acetaminophen , but not over-the-counter use. How many mothers would go to the doctor to get a prescription for a headache reliever when they could just open their medicine cabinet?
Well…
I was disappointed to hear Dr Peter McCullough speak to thin today on Newsmax.
I refused him highly, but something is going on between him and Malone.
The fact that Malone was picked by RFK jr to be on Kennedy team amd and not him… I don’t know if it has bearings , but he said that the real take away was the vaccines. When you give a child or mother a vaccine, say she is pg, and she has some pain or runs a fever, it’s the interaction of the Tylenol amd the vaccine that is the problem.
I need to know a lot more about this connection
Just think, these bastards we’re telling PG mothers to get vaccinated… the gold standard is NO MEDICINE when pregnant
. None… and all these Drs gave their female patients this f-king clot shot
Amd we know so many laid with aborted, deformed babies
I HATE my phone
1. Speak to this
2. I RESPECT him highly
3. So many PAID
You’re ignoring there is no problem. “the gold standard is NO MEDICINE when pregnant” Sorry, but you are 100% wrong. It is an indisputable fact that maternal fevers can damage embryos/fetuses. Not treating fever with medicine is a very bad idea.
I hope this has some effect, but given the massive increase in autism my suspicion is that this is only one of multiple causes – and not the most significant.
It could be as simple
I hear that they only recommended Tylenol in pregnancy in the last 25 years
And autism has gone crazy
IN THE LAST 25 YEARS
I’ll try to find the report
The time scale is right. And the popularity of the drug is right. You need way more proof than that, of course, but it’s a good starting point. I think by no we’ve all learned to ignore the “safe and effective” claims of the man behind the curtain — he’s just a damn lobbyist, and at times he won’t even take his own product.
Tylenol is also routinely given to kids after vaccination; there may well be a multiplier effect, since vax+tylenol is SOP, parsing out the effect of tylenol only could be difficult.
There has been an increase in autism diagnoses. It does not follow there has been an increase in autism.
“acetaminophen and its metabolites freely cross the placenta and have been found in cord blood, newborn urine, and fetal liver, “
The latency of the adverse health outcomes highlighted in the above epidemiologic studies is suggestive of fetal epigenetic programming. Xenobiotic exposures during critical windows of development have been shown to program the fetal epigenome, likely through maternal–fetal interaction via the placenta, leading to permanent biological and physiological change [15–17]. Among the molecular mechanisms by which the epigenome can be modified, DNA methylation of cytosine-guanine dinucleotides (CpGs) is a major process by which the placenta dynamically responds to changing conditions throughout pregnancy [17–19]. For example, in the context of environmental contaminants, several studies have associated in utero metals exposure to CpG methylation in the placenta [17, 18, 20, 21]. In support of the potential for acetaminophen to impact the epigenome, a recent study has demonstrated an association between prenatal acetaminophen exposure and CpG methylation in banked cord blood of children with ADHD [22]. Importantly, DNA methylation may be used as biomarker of in utero exposure and a predictor of later life outcomes [23]
https://pmc.ncbi.nlm.nih.gov/articles/PMC6682751/
Early 1960s: Tylenol became an over-the-counter medication, making it widely available to the public.
Decades following: Acetaminophen became the most commonly recommended over-the-counter pain reliever for pregnant women.
I’m pretty sure ADHD is mostly genetic. Blond hair, blue eyes, boy.
And is a problem mostly because of our German style public school system.
For ADHD, just “boy” will suffice.
He doesn’t sit quiet in class, like a girl.
The public schools functioned quite well before the wokiestas took charge. They still do in places where the community has rebuffed the wokiesta nonsense, still recognize that boys need PE/recess to burn off ‘energy’ and that we can’t force boys into an education regime that is female oriented without losing the boys. In contrast the wokiesta lefty run schools are failing.
IMO the larger problem is the refusal to recognize the differences between males and females. Generally boys play roughly, are more competitive. They need outlets for this and keeping them in rows of desks all day with any deviation from the current collaborative learning BS resulting in disciplinary action and/or shoving pills down their throat with a bogus ADHD diagnosis isn’t working. Being back mandatory PE and recess. Then recognize that teaching/education is dominated by females who, naturally seek to create policies more oriented to females and that those policies need careful evaluation to ensure we’re not trying to hammer the boy’s round peg into a square hole designed by/for female learners.
IMO we need true school choice. Let the public funding follow the Student to the educational environment selected by the Parents as the best fit to meet the unique situation of their Child.
Not to be discounted is the fact that mothers can apply for and get SSDI money for children with an ADHD diagnosis.
Schools can also receive additional funding for children with an ADHD diagnosis. The problem is that they’re very bad at helping such children. But I’m sure they enjoy the funds.
CommoChief, I upvoted you, but I hope you won’t be offended if I partially disagree.
The public schools were created as a method of indoctrinating low income Irish Catholic immigrants into Protestantism using their parents’ taxes. They did function quite well at this despicable task. And I’m not Catholic.
The public schools then started indoctrinating children into secularism. Most non-Catholics didn’t notice.
You are completely aware of what they’re doing now.
I don’t think you’re claiming there are no non-bogus ADHD diagnoses. If so, you may not have encountered a child with ADHD.
I wonder if you know why CNS stimulants are helpful for children with ADHD. I would be surprised if you don’t.
I couldn’t agree more that we need true school choice.
Aspirin was thought to be safe for use in children with fever after a viral infection until it was shown to be associated with Reye’s Syndrome. Maybe we have more to learn.
Aspirin was a miracle drug at the time of the Spanish Flu. It is now thought that many deaths of healthy persons (incl. many deaths of young military men) was iatrogenic, as it is known that lethal doses of aspirin were administered to many people, as it was considered entirely “safe.” Post-mortem examinations of many of the dead show evidence of symptoms we now recognize as those of acute aspirin poisoning.
Also to be considered is the post-vaccination administration of acetaminophen to infants. Some vaccines induce an infection-like reaction, including fever, that is typically treated with acetaminophen. As everyone knows, an infant brain isn’t developed (by a long shot), so the potential is there for the post-partum interruption of normal brain development by the drug’s metabolites in the infant’s body. I recently read somewhere that in countries were fever is considered a normal and healthy reaction to vaccines, acetaminophen is not administered and those countries’ incidence of autism is much lower. (It’s certainly not a surprise to find that doctors here in the US are over-medicating infants when they over-medicate everyone else.)
I still think the real cause of increased numbers of autism is accountable for the ridiculous expansion of the definition of autism.
See also ADHD in the 90s.
‘Scientists’ really undermined themselves when, for reasons known only to them, stopped tracking many specific and objective childhood development issues and instead, lumped many things together into Autism Spectrum Disorder, which is so broad now, it’s virtually meaningless. There are distinct, more objective elements of ASD, like a child being non-verbal. But, we haven’t really tracked the percentage of children who are non-verbal through the decades so we don’t have a very good idea of non-verbal children have really increased since WWII.
So now, we’ll have children who, for whatever reason, cannot communicate verbally and some who can’t communicate in any way lumped in with children who get ‘anxiety’ in public places and they’re both diagnosed with Autism Spectrum Disorder.
my observation is that austism is highly correlated with age of the parent at time of birth, either the mom or the dad or both. The older the parent, the higher probability of autism. We now have fairly good autism rate data on the age of parents since the early 2000’s but completely lack good autism rate data prior to 1980. The question is whether autism rates have increased when stratified by age of parent.
“Older parents” is hardly a new thing – even in previous centuries it was not uncommon for women to have children into their 40s and even 50s.
The increase in the incidence of autism is a late 20th C phenomenon, however.
True – but incomplete – babies born to older parents have been happening for a few centuries. The difference is the percentage of babies born to young parents have declined dramatically. there has been an overall shift to delaying pregnancy for later time in life across most every industrialized country as their society becomes wealthier.
Exactly. The redefinition of autism as well as ADHD was accomplished solely so that the pharmaceutical industry could sell more drugs and had nothing to do with any real increase in the incidence of either. But of course, having that opinion puts you in the unfavored minority. And the drugging of our children continues apace.
There are no drugs for autism.
I wish that explained the massive increase but it doesn’t even come close… a percent sure…. But not the vast majority of cases. And the kids with other issues being put under the ASD umbrella…. Explain them…
Scott Adams suggests that Tylenol is just a pharma-designated fall-guy. A small market (pregnant women) lost but other products protected.
Who would have guessed the autobiographical character in dilbert was the boss and not dilbert.
Ultimately, a warning about the potential hazard of this medicine in pregnant women is likely completely warranted. The only problem with yesterday’s presser (which is usually the only problem with Trump’s pressers ever) was Trump’s unscripted comments, something his staff should get him to avoid when he’s making public statements about sciencey stuff like this. He said, ‘Amish don’t have autism.’ This is, of course, incorrect. There are certainly Amish children who show indications of Autism at an early age. Unfortunately, there are no high-quality studies of Autism in the Amish community, and there likely never will be, because by their nature, the Amish A) Don’t participate in such studies, B) Aren’t enrolled in public or private school and C) Rarely find themselves in hospitals and D) are culturally predisposed to not even acknowledge developmental disorders in children, which makes it virtually impossible to capture good medical data.
He then added that Cubans don’t have money for Tylenol and they don’t have Autism, apparently not understanding that the patent for acetaminophen (Paracetamol) expired almost a half-century ago and it now costs pennies to produce, making it available literally everywhere in the world…even Cuba.
If you watched the evening newscasts, you will have noticed that much of the good information that came out in the presser was ignored to instead focus on Trump’s Amish and Cuba remarks. You cannot freelance with facts that are so easily checked. It undermines any benefit the broader message might produce.
RFK is a kook. This is price trump paid for 1% of the vote. Tylenol and green M&Ms didn’t make your baby autistic.
Repost your comments about how safe and effective the Covid shots were…and the masks… bet you’re still wearing yours …. I’m sure you went on and on about that too …….
Most of us understand that correlation does not imply causation but that doesn’t mean you ignore a possible cause because you haven’t studied it well enough to understand underlying mechanisms that may be at play.
People have been aware of this issue and studying it for more than a decade. To date, there is no reason to believe acetaminophen causes autism, and plenty of reason to think it can prevent autism.
There’s no evidence it can prevent autism. If that were true, we’d actually see fewer cases of autism post 1960 when Tylenol was made an OTC drug. That’s not the case.
Logic is not your enemy.
A few years ago I went to drop my daughter off for a school trip and was really surprised by how much medication was being taken in the trip! It was literally large boxes of the shit! Really was an eye opener!!
autism has become another political buzz word>>>welfare vehicle for many to abuse and milk the system,, once again,, with special treatments
the whole “Service animal” test has made america fail as we once again were bullied into…
are you saying military vets shouldnt be allowed to fly with a service animal etc……
Trump apparently hates pregnant women or why else would he act in ways guaranteed to increase autism rates. It is an indisputable fact that fevers in pregnant women can and occasionally do lead to developmental disabilities in their unborn children. Acetaminophen is the preferred medicine to treat fevers. (The alternative, NSAIDs prevent blood clotting and are thus inherently dangerous. in pregnant women.) Giving this information without justification will inevitably lead to untreated fevers.