In an announcement on Sept. 22, President Donald Trump mentioned that utilizing Tylenol throughout being pregnant will increase the chance of getting a child with autism, contradicting recommendation from main obstetrics consultants who say the favored drug could be very protected in being pregnant.
“Don’t take Tylenol. Combat like hell to not take it,” Trump mentioned 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, mentioned pregnant ladies shouldn’t take acetaminophen, the energetic ingredient in Tylenol, until they’ve an “extraordinarily excessive fever.”
“If you happen to can’t robust it out, should you can’t do it, that is what you’re going to must do,” Trump mentioned.
The American School 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 growth. 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 authorized to deal with fevers throughout being pregnant.
Trump’s announcement “isn’t backed by the complete physique of scientific proof and dangerously simplifies the various and complicated causes of neurologic challenges in kids,” mentioned ACOG President Dr. Steven Fleischman in a press release. “It’s extremely unsettling that our federal well being companies are keen to make an announcement that may have an effect on the well being and well-being of thousands and thousands of individuals with out the backing of dependable knowledge.”
Trump mentioned not treating fevers in pregnant ladies can’t trigger any hurt. “There is no draw back in not taking it,” he mentioned.
Untreated fever in being pregnant is related to miscarriage, fetal organ malformations and cardiovascular problems, and even autism, in accordance with a 2021 assertion from the Society for Maternal-Fetal Medication.
“The situations individuals use acetaminophen to deal with throughout being pregnant are way more harmful than any theoretical dangers,” Fleischman mentioned.
A number of research performed over the previous decade have probed whether or not acetaminophen will increase the chance of autism and different neurodevelopmental issues. The outcomes of those research have been blended, with some exhibiting a potential correlation and others exhibiting 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 creator, mentioned 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 college at Harvard T.H. Chan College of Public Well being and an environmental well being professor, mentioned 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 professional 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 mentioned.
The Trump Administration relied partly 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 due to this fact unreliable. “The research which have claimed an affiliation have been so deeply flawed which you could’t draw any conclusion,” he says.
A number of research, for instance, relied on ladies’s reminiscences 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’ve 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 function within the growth of autism.
Greater 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, seemed on the digital medical data from practically 2.5 million kids 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. Nonetheless, when the researchers performed 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 most probably attributable to genetics,” says Brian Lee, a professor of epidemiology at Drexel College and the examine’s lead investigator.
Analysis suggests that individuals with autism usually tend to endure from pain-causing situations akin to complications and migraines and should due to this fact be extra prone to take ache drugs. Pregnant ladies with the next genetic threat of autism could due to this fact be extra prone 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 provide is: Consuming ice cream is statistically related to drowning. However ice cream would not trigger you to drown.” It simply so occurs that each the charges of consuming ice cream and swimming go up in scorching climate.
In the course of the press briefing, Dr. Marty Makary, chief of the U.S. Meals and Drug Administration claimed that Baccarelli, who co-authored the evaluate, had mentioned there was a transparent causal relationship between acetaminophen use throughout being pregnant and an elevated threat of neurodevelopmental issues. Baccarelli, nevertheless, was unequivocal in his assertion to TIME that the evaluate didn’t present a causal hyperlink and that extra analysis was wanted “to verify the affiliation and decide causality.”
“As the one authorized medicine for ache and fever discount throughout being pregnant, acetaminophen stays an vital software 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 start,” Baccarelli wrote within the assertion. “After assessing the proof, my colleagues and I really useful 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 potential length, after session with their doctor about their particular person risk-benefit calculation.”
Baccarelli’s recommendation echoes what most docs already advise their pregnant sufferers to do.
Kenvue, the mother or father firm of Tylenol’s producer, instructed TIME in a press release that acetaminophen is the “most secure ache reliever choice for pregnant ladies as wanted all through their total being pregnant” and that with out it, ladies face harmful selections together with struggling by probably dangerous situations akin to fever or utilizing riskier alternate options.
“We imagine unbiased, 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 fogeys,” an organization spokesperson mentioned.
Kenvue’s shares dropped to an all-time low on Sep. 22, forward of Trump’s announcement, Barron’s reported.
Trump mentioned on the briefing that his administration was devoted to confronting the “horrible, horrible disaster” of autism. Kennedy mentioned NIH and different federal well being companies have been actively looking for potential causes of autism, together with probing the potential dangers of vaccines. Massive-scale research performed over a long time have proven no hyperlink between vaccines and autism.
Researchers say there isn’t a single trigger to the vary of situations 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 job.
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 mentioned it was additionally initiating a safety-label change for the drug.
