In an announcement on Sept. 22, President Donald Trump stated that utilizing Tylenol throughout being pregnant will increase the danger of getting a child with autism, contradicting recommendation from main obstetrics consultants who say the favored drug may be very protected in being pregnant.
“Don’t take Tylenol. Struggle like hell to not take it,” Trump stated throughout a White Home briefing.
The president, who was flanked by U.S. Well being and Human Companies (HHS) Secretary Robert F. Kennedy Jr. and different cupboard officers, stated pregnant ladies shouldn’t take acetaminophen, the energetic ingredient in Tylenol, except they’ve an “extraordinarily excessive fever.”
“In case you can’t powerful it out, should you can’t do it, that is what you’re going to must do,” Trump stated.
The American Faculty of Obstetricians and Gynecologists was fast to dispute Trump’s claims, saying that there was no clear proof linking the usage of acetaminophen to autism or different dangers to fetal improvement. Different pain- and fever-reducing drugs, akin to ibuprofen and aspirin, carry dangers throughout being pregnant, and acetaminophen is the one over-the-counter drug accepted to deal with fevers throughout being pregnant.
Trump’s announcement “just isn’t backed by the total physique of scientific proof and dangerously simplifies the numerous and sophisticated causes of neurologic challenges in youngsters,” stated ACOG President Dr. Steven Fleischman in a press release. “It’s extremely unsettling that our federal well being businesses are prepared to make an announcement that can have an effect on the well being and well-being of thousands and thousands of individuals with out the backing of dependable knowledge.”
Trump stated not treating fevers in pregnant ladies can’t trigger any hurt. “There isn’t any draw back in not taking it,” he stated.
Untreated fever in being pregnant is related to miscarriage, fetal organ malformations and cardiovascular issues, and even autism, in response to a 2021 assertion from the Society for Maternal-Fetal Medication.
“The circumstances folks use acetaminophen to deal with throughout being pregnant are much more harmful than any theoretical dangers,” Fleischman stated.
A number of research carried out over the previous decade have probed whether or not acetaminophen will increase the danger of autism and different neurodevelopmental issues. The outcomes of those research have been blended, with some displaying a attainable correlation and others displaying no hyperlink. None has proven a causal connection.
A evaluate of 46 of those research revealed in August within the journal BMC Environmental Well being concluded that there was a hyperlink between prenatal acetaminophen use and the incidence of neurodevelopmental issues together with autism and attention-deficit/hyperactivity dysfunction (ADHD). Dr. Andrea Baccarelli, a senior writer, stated in an emailed assertion to TIME that he had mentioned the findings of the evaluate with Kennedy and Nationwide Institutes of Well being Director Dr. Jay Bhattacharya in latest weeks.
Baccarelli, dean of the school at Harvard T.H. Chan College of Public Well being and an environmental well being professor, stated given the evaluate’s conclusions, “warning about acetaminophen use throughout being pregnant—particularly heavy or extended use—is warranted.”
Baccarelli has acknowledged that he served as an knowledgeable witness in a case involving potential hyperlinks between acetaminophen use throughout being pregnant and neurodevelopmental issues. “This involvement could also be perceived as a battle of curiosity,” the evaluate stated.
The Trump Administration relied partially on the evaluate as the idea for the announcement. However many obstetrics consultants have questioned the validity of the evaluate’s conclusions.
Dr. Nathaniel DeNicola, an ob-gyn who advises ACOG on environmental well being points, says the issue with the evaluate is that it was based mostly on research that have been principally poorly designed and subsequently unreliable. “The research which have claimed an affiliation have been so deeply flawed that you would be able to’t draw any conclusion,” he says.
A number of research, for instance, relied on ladies’s recollections to find out if and the way a lot acetaminophen they took throughout their being pregnant. The ladies have been requested to recall these particulars weeks, months, and in some circumstances years after the very fact, DeNicola says. “Anybody who has been requested the query, ‘What did you will have for lunch yesterday?’ is aware of that you simply are likely to misremember issues, even issues from the latest previous,” he says.
Most research additionally didn’t take the potential affect of genetics on autism into consideration, DeNicola says—a consequential oversight provided that genetic components play a major position within the improvement of autism.
Larger high quality research—particularly a handful of them which have taken genetics into consideration—have proven no hyperlink between prenatal acetaminophen use and autism threat, DeNicola says. One such examine, which was revealed in 2024 in JAMA, regarded on the digital medical information from practically 2.5 million youngsters who have been born in Sweden between 1995 and 2019. In an preliminary evaluation that didn’t management for genetic components, the researchers discovered a small affiliation between ladies who used acetaminophen throughout being pregnant and the incidence of autism, ADHD, and mental incapacity. Nevertheless, when the researchers carried out a follow-up examine that in contrast siblings who have been uncovered to acetaminophen throughout their mom’s being pregnant to those that weren’t uncovered to the drug, they discovered no hyperlink.
“What this tells us is that the [initial] affiliation was more than likely as a consequence of genetics,” says Brian Lee, a professor of epidemiology at Drexel College and the examine’s lead investigator.
Analysis suggests that folks with autism usually tend to undergo from pain-causing circumstances akin to complications and migraines and will subsequently be extra more likely to take ache drugs. Pregnant ladies with the next genetic threat of autism might subsequently be extra more likely to take acetaminophen, Lee says.
Requested in regards to the evaluate revealed in August, which included his group’s JAMA examine, Lee says its conclusions have been flawed as a result of it was based mostly on principally flawed research. “Rubbish in, rubbish out,” he says.
Correlation can be, critically, not causation, Lee says. “The instance I like to present is: Consuming ice cream is statistically related to drowning. However ice cream does not trigger you to drown.” It simply so occurs that each the charges of consuming ice cream and swimming go up in sizzling climate.
Throughout the press briefing, Dr. Marty Makary, chief of the U.S. Meals and Drug Administration claimed that Baccarelli, who co-authored the evaluate, had stated there was a transparent causal relationship between acetaminophen use throughout being pregnant and an elevated threat of neurodevelopmental issues. Baccarelli, nonetheless, was unequivocal in his assertion to TIME that the evaluate didn’t present a causal hyperlink and that extra analysis was wanted “to substantiate the affiliation and decide causality.”
“As the one accepted treatment for ache and fever discount throughout being pregnant, acetaminophen stays an essential instrument for pregnant sufferers and their physicians. Excessive fever can pose dangers to each the mom and the fetus, together with neural tube defects and preterm beginning,” Baccarelli wrote within the assertion. “After assessing the proof, my colleagues and I advisable a balanced strategy based mostly on the precautionary precept: Sufferers who want fever or ache discount throughout being pregnant ought to take the bottom efficient dose of acetaminophen, for the shortest attainable length, after session with their doctor about their particular person risk-benefit calculation.”
Baccarelli’s recommendation echoes what most medical doctors already advise their pregnant sufferers to do.
Kenvue, the guardian firm of Tylenol’s producer, advised TIME in a press release that acetaminophen is the “most secure ache reliever choice for pregnant ladies as wanted all through their whole being pregnant” and that with out it, ladies face harmful decisions together with struggling by means of probably dangerous circumstances akin to fever or utilizing riskier alternate options.
“We imagine impartial, sound science clearly reveals that taking acetaminophen doesn’t trigger autism. We strongly disagree with any suggestion in any other case and are deeply involved in regards to the well being dangers and confusion this poses for anticipating moms and oldsters,” an organization spokesperson stated.
Kenvue’s shares dropped to an all-time low on Sep. 22, forward of Trump’s announcement, Barron’s reported.
Trump stated on the briefing that his administration was devoted to confronting the “horrible, horrible disaster” of autism. Kennedy stated NIH and different federal well being businesses have been actively trying to find attainable causes of autism, together with probing the potential dangers of vaccines. Giant-scale research carried out over a long time have proven no hyperlink between vaccines and autism.
Researchers say there isn’t any single trigger to the vary of circumstances that fall below the umbrella of autism spectrum dysfunction. As a substitute, consultants imagine that genetics along with myriad environmental components—together with maternal age and well being and publicity to air pollution and contaminants like heavy metals—play a task.
Following the White Home briefing, the FDA introduced that it was issuing a discover to physicians highlighting the potential dangers of acetaminophen use throughout being pregnant. The company stated it was additionally initiating a safety-label change for the drug.
