Documents: Tylenol Maker Privately Acknowledged Growing Evidence of Autism Risk
The pharmaceutical giant behind Tylenol privately acknowledged as early as 2018 that mounting scientific evidence pointed to a potential link between the drug’s use during pregnancy and the development of neurodevelopmental disorders like autism in children, according to internal documents obtained by the Daily Caller News Foundation.
“The weight of the evidence is starting to feel heavy to me,” wrote Rachel Weinstein, then U.S. Director of Epidemiology for Janssen, the pharmaceutical division of Johnson & Johnson, in a 2018 email regarding prenatal exposure to acetaminophen, the active ingredient in Tylenol.
Although Johnson & Johnson marketed Tylenol at the time, its consumer health division was spun off in 2023 into a separate publicly traded company, Kenvue, which now owns all rights and liabilities associated with the product. Still, internal communications from J&J dating back over a decade suggest that company officials had long tracked concerns about the drug’s safety during pregnancy—well before public scrutiny intensified in recent years.
As far back as 2008, company officials were fielding inquiries from both physicians and consumers about a potential link between Tylenol and autism. “Not much choice but to consider this a safety signal that needs to be evaluated,” wrote Andre Mann, then a lead for Johnson & Johnson’s Office of Consumer Medical Safety, in response to a physician’s letter.
In 2012, Leslie Shur, head of the J&J division responsible for monitoring post-market drug safety, was alerted to similar concerns from a parent. One internal message noted the issue “in case this goes to press,” indicating an awareness of the potential for public fallout.
By 2014, references to then-CEO Alex Gorski in internal correspondence suggest the issue had reached the highest levels of corporate leadership.
A 2018 internal presentation labeled “privileged and confidential” further acknowledged that studies had found a “somewhat consistent” association between prenatal acetaminophen exposure and neurodevelopmental disorders. It also noted that large-scale meta-analyses—studies that combine data from multiple scientific papers—had reported similar associations, even as the company pointed to methodological concerns such as confounding variables and subjectivity in the assessment of autism-related traits.
Despite these internal discussions, both Johnson & Johnson and Kenvue have publicly denied any causal link between Tylenol use during pregnancy and autism. In a statement to the DCNF, Kenvue spokesperson Melissa Witt said, “We have continuously evaluated the science and continue to believe there is no causal link between acetaminophen use during pregnancy and autism.”
Photo credit: Flickr
