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American Focus > Blog > Health and Wellness > A Doctor Fact Checks FDA Commissioner Dr. Marty Makary’s Claims On Tylenol And Autism
Health and Wellness

A Doctor Fact Checks FDA Commissioner Dr. Marty Makary’s Claims On Tylenol And Autism

Last updated: September 24, 2025 8:51 am
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A Doctor Fact Checks FDA Commissioner Dr. Marty Makary’s Claims On Tylenol And Autism
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President Trump Makes Announcement On New Theories On Autism Causation In Children

WASHINGTON, DC – SEPTEMBER 22: U.S. President Donald Trump (L) and Health and Human Services Secretary Robert F. Kennedy Jr. (R) observe as FDA Commissioner Dr. Marty Makary (C) presents remarks during an announcement in the Roosevelt Room of the White House on September 22, 2025. (Photo by Andrew Harnik/Getty Images)

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In a recent appearance on FOX, Laura Ingraham’s interview featured FDA Commissioner Dr. Marty Makary, who stated, “The overwhelming body of evidence points to a causal relationship. These words come directly from the dean of the Harvard School of Public Health.”

Dr. Makary’s remarks were linked to a study that examined the use of acetaminophen, commonly known as Tylenol, and its correlation with autism development during pregnancy. This research highlighted a positive relationship observed in 27 out of 46 studies analyzed.

It is crucial to note that the word “association” does not equate to causation. The authors of the study, including Dr. Andrea Baccarelli, the dean at Harvard’s School of Public Health, have explicitly noted, “our analysis demonstrated evidence consistent with an association between exposure to acetaminophen during pregnancy and offspring with neurodevelopmental disorders, including Autism Spectrum Disorder (ASD) and Attention Deficit Hyperactivity Disorder (ADHD), though limitations inherent to observational studies hinder definitive causation.”

This distinction—between association and causation—is vital. For example, while getting up early may correlate with high productivity, it is not the act of rising early that guarantees success; rather, productivity is a result of several factors, including personal effort and diligence.

Observational studies inherently lack the ability to establish causation due to their nature, which typically does not involve randomization. Individuals self-select their exposure, which can distort the findings because of pre-existing differences among study participants—differences that might impact the measured outcomes.

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Furthermore, confounding variables, or hidden factors influencing the results, may skew data interpretation. For instance, in this context, the fever itself, not Tylenol, might play a decisive role in autism development. Similarly, an underlying infection in pregnant women could be the actual contributor to neurodevelopmental issues rather than the medication used to treat symptoms. Such confounders, left uncontrolled, can nullify the study’s claims of causation.

This disparity is why randomized controlled trials are regarded as the gold standard for establishing causal relationships. Such trials effectively mitigate confounding factors and biases that naturally occur in observational research.

While Trump’s administration has leaned on findings from the Environmental Health study to assert the link between Tylenol and autism, it’s important to consider that the most comprehensive study addressing this concern was published in JAMA. This landmark research surveyed over 2 million children across the United States and Sweden and found no evidence supporting a link between prenatal Tylenol use and autism development.

The spread of misinformation regarding this issue could have significant public health consequences, generating undue anxiety and hesitance around a medication historically considered safe and effective for both pregnant women and children. If expectant mothers become fearful of using Tylenol to manage fevers, they risk facing untreated complications like miscarriages, birth defects, and premature births, in addition to the mental health risks associated with unmanaged pain.

Ensuring accuracy and transparency in health communications is essential for safeguarding the well-being of the populace. The proliferation of misinformation yields no beneficiaries and can lead to dire outcomes.

See also  FDA rules on dye, nicotine levels

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TAGGED:AutismChecksClaimscommissionerdoctorFactFDAMakarysMartyTylenol
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