by Brenda Baletti, Ph.D., Childrens Health Defense:
Emails obtained by the Daily Caller News Foundation show that as long ago as 2008, officials at Johnson & Johnson, the original maker of Tylenol, were privately concerned about what they believed to be credible evidence of a possible link between autism and acetaminophen. The FDA was also aware of the link.
Makers of Tylenol and the U.S. Food and Drug Administration (FDA) knew for years about the likely association between the drug’s use during pregnancy and neurodevelopmental disorders, including autism, according to documents obtained in lawsuits against Kenvue.
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“The weight of evidence is starting to feel heavy to me,” Rachel Weinstein, U.S. director of epidemiology for Johnson & Johnson’s (J&J) pharmaceutical division Janssen, said in an email commenting on several studies showing the link.
Daily Caller News Foundation obtained the emails from Keller Postman LLC, the law firm representing plaintiffs in a federal class action lawsuit against Kenvue.
J&J made Tylenol until 2023, when it spun off production to Kenvue, a separate company.
The email revelations follow President Donald Trump’s announcement last week that pregnant women should not take Tylenol, and the FDA’s announcement that it will add warnings to products containing acetaminophen.
The updated product labels will warn that acetaminophen may be associated with a higher risk of neurological conditions, including autism and attention-deficit/hyperactivity disorder (ADHD), in children. The FDA said it will also warn physicians and the public about the risk.
Mainstream media and public health organizations attacked the warnings as unfounded or overblown. Some news organizations quoted scientists — like University of Massachusetts epidemiologist Ann Bauer — who published studies identifying the link between Tylenol and autism and called for warnings, but who are now publicly backpedaling on their concerns.
However, the Daily Caller found that despite confusion in the media and among public health experts, emails show that as early as 2008, officials at J&J were privately concerned about credible evidence of a possible link between autism and acetaminophen. They acknowledged the link in an email and suggested further investigation.
Internal FDA meta-analyses shared with The Defender show that the agency had for years considered adding new warnings about acetaminophen’s side effects for children.
In 2019, FDA scientists conducted a meta-analysis that found urogenital disorders in infants linked to the drug. The scientists also noted links to neurodevelopmental issues. In 2022, the FDA conducted another meta-analysis that found a link to ADHD.
Tylenol makers ‘closely tracked a drumbeat of scientific publications’ showing link to autism
The Daily Caller News Foundation obtained emails spanning more than a decade indicating that company insiders at J&J had been alerted about the possible link between acetaminophen and neurological disorders. The emails showed J&J even considered pursuing further research, but decided against it.
The outlet also obtained a 2012 email by Leslie Shur, head of the division at J&J that monitors side effects, acknowledging another consumer complaint about the issue, and a 2014 email showing that the issue was raised with CEO Alex Gorsky, whose name is misspelled in the email.
According to journalist Emily Kopp, who wrote the Daily Caller story:
“The makers of Tylenol have closely tracked a drumbeat of scientific publications finding an association between taking the blockbuster drug in pregnancy and infancy and autism risk, other company documents show.
“A 2018 internal presentation the company labeled ‘privileged and confidential’ acknowledges that observational studies show a ‘somewhat consistent’ association between prenatal exposure to Tylenol and neurodevelopmental disorders.
“Another presentation slide acknowledges that larger meta-analyses — reviews summarizing multiple scientific studies — found an association, but notes weaknesses of these studies like confounding variables and subjectivity in measuring autistic traits.”
A Kenvue spokesperson told the Daily Caller that the company believes there is “no causal link between acetaminophen use during pregnancy and autism” and that its projects are “safe and effective” when used as directed on the label.
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