The pharmaceutical company that produces Tylenol has reportedly acknowledged a potential link between certain medications taken during pregnancy and neurodegenerative disorders, including autism in children, as far back as seven years ago.
“The evidence is starting to weigh heavily on me,” noted Rachel Weinstein, the U.S. Epidemiology Director at Janssen, Johnson & Johnson’s pharmaceutical branch, in 2018.
While some media outlets and public health experts have dismissed the conclusions drawn by figures like President Donald Trump and Robert F. Kennedy Jr. regarding the Department of Health and Human Services, at least one stakeholder sees it as indicative of certain reliability about the company’s products.
Documents obtained by DCNF from the law firm Keller Postman LLC show that they have initiated a class action lawsuit against Kenvue in the Southern District of New York.
Numerous highly cited studies suggest that genetics play a more significant role than environmental factors in autism spectrum disorders. There’s ongoing debate within the scientific community about the causes, and many researchers lean toward the idea that multiple factors might contribute.
The FAQ section on the company’s website states, “Acetaminophen is the active ingredient in all Tylenol® products and over 600 other over-the-counter and prescription drugs.”
Back in 2008, long before Weinstein’s comments, Johnson & Johnson began to receive inquiries from both consumers and healthcare professionals about possible correlations.
“This seems like a safety signal worthy of further evaluation, though choices are limited,” wrote Andre Mann, a medical safety officer at J&J, after a doctor expressed concerns in a letter.
In 2012, Leslie Schul, who headed the division monitoring drug side effects, was informed by her father about concerns linking acetaminophen to autism.
By 2014, worries regarding the relationship between Tylenol and neurological disorders were apparently surfacing at the executive level.
Internal company documents suggest that Tylenol’s manufacturers had been closely monitoring studies indicating a link between the drug’s use during pregnancy and increased autism risk in infants. An internal presentation deemed “Privileged and Confidential” from 2018 recognized that observational studies found a “somewhat consistent” association between prenatal exposure to Tylenol and certain neurodevelopmental disorders, while noting some shortcomings in these studies, including confounding variables.
In a statement, a spokesperson for Johnson & Johnson remarked that “the company sold its consumer health business years ago and retains all rights and liabilities related to Tylenol’s commercial sale.” Attempts to reach specific individuals for comment were unsuccessful.
“The health and safety of our consumers are our utmost priority,” stated Melissa Witt, spokesperson for Kenvue. “We continue to evaluate scientific evidence and maintain that there is no established cause-and-effect relationship between acetaminophen use during pregnancy and autism. It remains the safest option for managing pain throughout pregnancy.” Furthermore, she advised that expectant mothers should consult their doctors before taking any over-the-counter medications, including acetaminophen.
A class action lawsuit against Kenvue is set for hearing at the Second Circuit Court of Appeals on October 9th, following a summary judgment made in September 2023. A legal representative highlighted the significant public health consequences of restricting medication options for pregnant women.
Ashley Keller, the attorney representing families of children with autism, argues that the judicial decisions are overextending and that potential risks should not be overlooked.
Internal communications indicate that Johnson & Johnson employees discussed literature reviews linking Tylenol use in pregnant women to potential autism-related outcomes.
Weinstein once appreciated the strength of the association found in some studies and even considered conducting further research to explore the implications further, although the outcome was never pursued. The 2018 company presentation acknowledged that available options for pregnant women remain limited, often directing them to Tylenol.
Tylenol encounters limited competition for pain relief among pregnant women due to possible complications associated with other medications.
The company has carried out a “social listening” study that tracked Google searches and social media discussions regarding Tylenol and autism from January 2020 to October 2023.
By 2023, high-level executives conceded that the discourse surrounding potential risks associated with Tylenol could profoundly affect the brand.
Since launching Tylenol as a “megabrand” in 2015, the company has sought to present its product as essential during various life stages, including pregnancy and early childhood.
Class action lawsuits center around allegations that the company may have overlooked credible links between the drug and autism. Some experts claim there were statistical errors in studies, failing to account for elements such as genetic predispositions that might complicate the association.
Parker stated that multiple peer-reviewed papers have explored genetic and environmental issues further linking acetaminophen to autism risk.
