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FDA Stayed Silent As Internal Reports About Potential Tylenol Risks Piled Up
The Food and Drug Administration (FDA) defied the advice of its own drug safety experts to warn pregnant women about Tylenol for nearly a decade, internal reports and presentations obtained by the Daily Caller News Foundation reveal.
FDA rank-and-file scientists repeatedly recommended the agency release information about Tylenol in pregnancy across three scientific reviews conducted in 2016, 2019, 2022 and two memos, one from the FDA’s maternal health division in 2016 and one from the FDA’s urological health division in 2017.
The scientific literature posits many plausible drivers of autism, the most well-established of which are genetic, and the FDA drug safety experts acknowledged that the research linking the condition to Tylenol is far from ironclad.
Still, as alarm bells rang within FDA headquarters and the boardrooms of Tylenol’s manufacturers, pregnant women heard nothing from either the government or the manufacturers about the potential risks until the September announcement by President Donald Trump and Health and Human Services Secretary Robert F. Kennedy Jr. (RELATED: SCOOP: Tylenol Maker Privately Admitted Evidence Was Getting ‘Heavy’ For Autism Risk In 2018)
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FDA leadership declined to update its webpage about over-the-counter painkillers in pregnancy, repeatedly falling back on language first issued in January 2015. But that statement simply acknowledged that “FDA is aware of concerns” about Tylenol and attention deficit hyperactivity disorder (ADHD), citing just one scientific paper.
At the urging of Trump and Kennedy, FDA finally released a nuanced statement in September cautioning pregnant women about Tylenol while acknowledging that aspirin, ibuprofen and high fevers all pose their own risks. That move was first recommended by an FDA drug safety expert nine years earlier.
The DCNF obtained the FDA documents from the law firm Keller Postman LLC, which brought a class action lawsuit against Tylenol maker Kenvue, a legally independent spinoff of Johnson & Johnson. The personal injury law firm, which often brings class action lawsuits, obtained the documents from FDA via the Freedom of Information Act.
Tylenol, a brand name for acetaminophen, first received FDA approval in 1955 before modern drug laws tightened clinical trial requirements in 1962.
Some experts argue that neurological damage occurs due to a toxic byproduct of acetaminophen called NAPQI. Babies and children with autism may struggle to metabolize the drug, resulting in higher levels of NAPQI, which kills cells.
A figure from Zhao et al., a 2023 paper in Clinical and Experimental Pediatrics.
Most autism specialists acknowledge that many genetic and environmental ingredients make up the complex scientific formula determining autism risk. According to a theory favored by Kennedy, many of the traits and exposures associated with autism have also been shown to make metabolizing acetaminophen more difficult.
“If you look at the evidence as a whole, if you look at all of the things that determine the risk of autism, all of those things make acetaminophen more or less dangerous to an individual,” said WPLab, Inc. CEO William Parker, a scientist who has discussed the issue with Kennedy, told the DCNF.
Warning Signs In 2014
An internal memo reveals that the agency first began examining acetaminophen in pregnancy 11 years ago, in May 2014, after an April 2014 study published in the Journal of the American Medical Association raised concerns about the drug and ADHD-like behaviors, prompting its sole statement on the issue for the next decade — an 2015 FDA webpage that acknowledging that “FDA is aware of concerns” and citing that single study.
Less than two years later, in October 2016, FDA Senior Medical Officer Andrew Mosholder had reviewed eight observational studies with seven showing an association between acetaminophen and issues including attention deficits, delayed motor development and autistic behaviors.
Mosholder’s 22-page report recommended that FDA issue a nuanced warning: Tylenol in pregnancy could cause neurological harm and the drug should be used sparingly, but other painkillers are associated with more definite risks and Tylenol will sometimes be necessary to reduce fever. The report also recommended more toxicology studies — laboratory studies designed to uncover the potential toxicity of a drug.
Mosholder declined to comment.
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https://dailycaller.com/2025/10/21/fda-stayed-silent-potential-tylenol-risks-internal-reports/