President Donald Trump said his government is relating acetaminopus, the active ingredient of Tylenol, to autism and recommending that pregnant women avoid, in most cases, the use of the drug.
“Tylenol is not good-I’m going to say that-it’s not good. That’s why they are strongly recommended that women limit Tylenol use during pregnancy unless it is medically necessary,” Trump said on a White House event alongside Robert F. Kennedy Jr., his health secretary.
The announcement is the latest example of how Kennedy and Trump have sought to change health guidelines and practices in their government. Although there are numerous studies on the causes of autism, decades of scientific research have not yet identified a single cause for the condition.
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Trump also took advantage of the event to criticize children’s vaccination policies, suggesting that immunization calendars should be spaced. He said he believed that children should not receive vaccines that protect against multiple diseases at the same time, such as the triple viral (measles, mumps and rubella), and that these vaccines should be applied over a longer period.
“About vaccines, it would be better, instead of a single visit, where the baby is overloaded with several doses, doing this four or five times,” said Trump.
Trump also stated that the National Health Institute (NIH) will announce 13 great research scholarships to study autism.
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Kenvue’s shares, Tylenol’s manufacturer, fell 7.5% on Monday, closing at the historic minimum. Kenvue said on Sunday (21) that “independent and solid science” shows that the use of acetaminophen does not cause autism.
“I ordered HHS to set an unprecedented effort in all agencies to identify all causes of autism,” Kennedy said on Monday.
The secretary said that the FDA will issue a warning to doctors about the risk of acetaminophen during pregnancy and start the process to change the safety labels of the drug. HHS will also launch a “national public utility campaign to inform families and protect public health”.
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Kennedy also stated that leucovorine, a little known drug, can be useful treatment for children with autism. The drug, also known as folinic acid, is currently used to treat side effects of anemia caused by certain cancer medications.
Years of study
For over a decade there have been allegations that relate acetaminophen to autism. An observational study of 2008 suggested that its use to treat fevers in children from 12 to 18 months could be associated with an increase in the likelihood of autistic spectrum disorder, although the authors have requested further research.
FDA revised the risks of using painkillers during pregnancy in 2015 and said the data was insufficient to make recommendations.
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In 2019, researchers at Johns Hopkins analyzed data from Birth Birth Cohort and found that children whose umbilical cord blood samples contained the highest levels of acetaminopus were about three times more likely to be diagnosed with attention/hyperactivity deficit disorder or autistic spectrum disorder. This was also an observational study, so less rigorous scientifically.
In 2021, a group of researchers published in the Nature Reviews Endocrinology A warning to caution, saying that increasing experimental and epidemiological research suggests that prenatal exposure to acetaminophen can alter fetal development and increase the risk of conditions such as autism. Several doctors and professional groups, including the American College of Obstetricians and Gynecologists, contested this conclusion, stating that “patients should not be removed from the many benefits of acetaminophen.”
A later study of 2024, which analyzed records of nearly 2.5 million siblings born in Sweden between 1995 and 2019, found no increased risk of autism when mothers used acetaminophen during pregnancy.
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Earlier this year, a review of 46 previous studies concluded that prenatal exposure to paracetamol may increase the risk of neurodes-development disorders, but found no evidence that it directly causes these disorders.
One of the authors of this study, Andrea Baccarelli, acted as a specialist witness to the authors of processes that claim that prenatal exposure to Tylenol caused autism.
In 2023, Federal Judge Denise Cote in Manhattan rejected the scientific evidence presented in the processes, stating that they were based on failure science. Before excluding Baccarelli’s testimony, the judge said he did not apply “enough rigor” to measure the association between the use of paracetamol in the womb and neurodes -development disorders.
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The plaintiffs have appealed, and the arguments are scheduled for this year in Manhattan. Legal experts state that the HHS declaration of autism may be considered by appeal judges, but will not replace legal criteria for admissible evidence.
