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American Focus > Blog > World News > Trump announces FDA will change Tylenol safety label, urges pregnant mothers to prevent autism risk in children: ‘Don’t take it!’
World News

Trump announces FDA will change Tylenol safety label, urges pregnant mothers to prevent autism risk in children: ‘Don’t take it!’

Last updated: September 23, 2025 6:46 am
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Trump announces FDA will change Tylenol safety label, urges pregnant mothers to prevent autism risk in children: ‘Don’t take it!’
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WASHINGTON — On Monday, President Trump advised expectant mothers to refrain from using Tylenol, citing research that links the widely-used pain reliever with an increased risk of autism in their children.

“Do not take Tylenol! Just don’t do it,” Trump insisted during a press briefing held in the Roosevelt Room at the White House. He shared his views on various topics, including pregnancy, women’s health, vaccinations, drug safety, and autism.

He further mentioned, “Ideally, you’d avoid it entirely, but if the pain is unbearable or there’s a significant issue, you might have to consider it.”

According to Trump, the only acceptable circumstance for pregnant women to use Tylenol, an acetaminophen brand, would be in the event of a severe fever.

President Donald Trump (R), joined by Health and Human Services Secretary Robert F. Kennedy Jr. (C) and FDA Commissioner Dr. Marty Makary, announces critical medical findings related to American children’s health in the Roosevelt Room at the White House on September 22, 2025. Getty Images

This guidance stands in contrast to medical organizations that assert the drug, a staple for 70 years, is safe during pregnancy. More than half of all pregnant women report using the medication, as it is typically seen as the safest choice for treating pain.

Nonetheless, the Trump administration is highlighting an expanding volume of studies indicating a potential link between acetaminophen use in pregnancy and autism in children.

A noteworthy study from Mount Sinai and Harvard University released in August reviewed existing research and found that a significant majority of studies indicated that expectant mothers taking acetaminophen had a higher likelihood of their children being diagnosed with autism.

Health and Human Services Secretary Robert F. Kennedy Jr. is also advising that children displaying signs of autism be administered leucovorin, a medication that assists in correcting folate deficiencies, as low prenatal folate levels have been linked to neurological disorders in children as per some studies.

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While not a definitive treatment, HHS claims this medication could help improve speech for autistic children.

The FDA is slated to revise the acetaminophen packaging to highlight potential pregnancy risks and will send a notification to healthcare providers regarding these warnings.

Tylenol Extra Strength, containing acetaminophen. Getty Images

Trump indicated that the FDA would advise against the use of acetaminophen for children “immediately” and emphasized that kids should also avoid the drug.

Kenvue, the company that produces Tylenol, contested the president’s claims.

“Decades of thorough research, supported by leading medical experts and global healthcare authorities, find no trustworthy evidence linking acetaminophen to autism,” a spokesperson for Kenvue stated.

They affirmed their support for the vast range of health professionals who concur with this understanding and pledged to continue exploring options to safeguard the well-being of American families.

Trump has urged the US Department of Health and Human Services, overseen by Secretary Robert F. Kennedy Jr., and its various agencies to examine causes of autism in the United States, which he described as “one of the most alarming public health issues we face today.”

Autism prevalence has surged by 400% since 2000, affecting 1 in every 31 children in the US.

Tylenol boxes with acetaminophen on display at a CVS. Getty Images
President Donald Trump speaks during a press event at the Roosevelt Room, White House. AP
Kenvue has expressed disagreement with Trump’s assertions regarding the correlation between acetaminophen and autism. Getty Images

The White House referred to evidence from research indicating “consistent correlations between acetaminophen usage during pregnancy and autism,” originating from studies conducted by Johns Hopkins and the Boston Birth Cohort. Similarly, the Nurses Health Study, involving researchers from esteemed universities such as Yale, Columbia, and Harvard, analyzed data from 9,000 children, which the White House claims showed a relation between acetaminophen and neurodevelopmental disorders.

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On Monday, the National Institutes of Health (NIH) unveiled the Autism Data Science Initiative, a $50 million research project that will consolidate information from 13 different initiatives to investigate autism and possible contributing factors like dietary habits, environmental pollutants, and psychological stress.

“Through the Autism Data Science Initiative, we aim to amalgamate influential datasets like never before,” stated NIH Director Dr. Jay Bhattacharya. “This initiative will merge genetic, biological, and environmental data, paving the way for breakthroughs to deepen our insights into autism and enhance lives.”

HHS also included a note emphasizing that while many studies have indicated a connection between acetaminophen and neurological conditions, a definitive causal link has not been established, and some studies in the scientific literature provide different findings.

Trump additionally suggested that parents consider delaying the vaccine schedule for their children, asserting that he is not a medical professional but sharing his perspective.

Trump announced that the FDA will update the acetaminophen packaging in light of these new findings. Getty Images

Trump voiced concerns regarding the extensive vaccine schedule, urging for a staggered administration over several visits. REUTERS

“When it comes to a young, vulnerable child receiving a barrage of vaccines—potentially 80 different types—all at once, it raises concerns. Ideally, pregnant women would avoid Tylenol, and children should also have their vaccine doses spaced out over multiple appointments instead of crowded into one,” Trump elaborated.

He specifically mentioned that the Hepatitis B vaccine should not be given until children reach the age of 12, advocating for staggered vaccine administration during pediatric healthcare visits.

Trump also noted that the Amish community, known for reduced rates of autism and chronic illnesses, may attribute these phenomena to their lower reliance on vaccinations and medications.

“You have a fragile little child, and they receive a significant number of vaccines all at once. Ideally, the mother avoids Tylenol, and the vaccine process should occur over several visits instead of one massive session,” Trump reiterated.

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TAGGED:announcesAutismChangeChildrenDontFDAlabelMothersPregnantPreventRiskSafetyTrumpTylenolurges
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