Researchers, trade orgs speak out against Tylenol, autism link

Lately, it’s not a fun time to be Tylenol.

It all started in late September when President Trump, Department Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., and other healthcare agency leaders held a press conference drawing a link between over-the-counter (OTC) Tylenol use by pregnant people and autism. In a press release the same day, the Trump administration announced a plan to “tackle [the] autism epidemic.”

Things then escalated last week: Texas Attorney General Ken Paxton sued the makers of Tylenol—current drugmaker Kenvue, which has sold it since 2023, and Johnson & Johnson, which sold it for decades previously—saying the companies knowingly hid risks of the medicine on children’s brain development. According to reporting from Axios, legal experts worry this could fuel more anti-pharma lawsuits.

HHS Press Secretary Emily Hilliard told us in a statement the FDA is updating acetaminophen’s safety label, including “ongoing research into prenatal exposures and child development—not a conclusion that acetaminophen causes autism.”

In an Oct. 29 press conference, Kennedy appeared to soften his prior warnings, saying there wasn’t “sufficient” evidence the drug “definitely causes” autism and a “cautious approach” was needed.

What does Big Pharma say? While Kenvue’s stock has been on a consistent decline since early September, neither Kenvue’s nor J&J’s stocks seemed to be majorly impacted by either moment.

In an emailed statement sent to Healthcare Brew, Kenvue spokesperson Melissa Witt wrote the company is “deeply concerned by the perpetuation of misinformation on the safety of acetaminophen” and said it would “vigorously defend [itself] against these claims and respond per the legal process.”

On Monday, it was announced consumer goods manufacturer Kimberly-Clark—which owns major companies like Huggies, Kleenex, and Cottonelle—would buy Kenvue for more than $40 billion. Kenvue’s stock rose nearly 16% after the market opened Monday.

J&J spokesperson Clare Boyle said the company had divested from Tylenol “years ago,” adding “all rights and liabilities associated with the sale of its over-the-counter products, including Tylenol (acetaminophen), are owned by Kenvue.”

President and CEO Scott Melville of the Consumer Healthcare Products Association, a trade organization that represents OTC drugmakers, told us in an emailed statement “the resulting confusion among expectant mothers and families has been both unnecessary and deeply concerning.”

“We want to stress that regulatory decisions need to be clearly science-based. Otherwise, there is a risk of eroding trust in public health institutions and unnecessary anxiety on families seeking safe, effective care,” he added.

What do the experts say? Throughout this debacle, researchers and birthing experts have pushed back against assertions that Tylenol is dangerous from the Trump administration.

While some compiled studies have previously found potential evidence of a link between acetaminophen use and neurodevelopmental disorders, researchers say this was due to a lack of genetic data.

One of the largest studies about Tylenol use among pregnant people sampled roughly 2.5 million children who were born between 1995 and 2019 and had a sibling control in Sweden, with follow-up through December 2021. The findings saw “no evidence” of an increased risk of developmental disabilities when using acetaminophen during pregnancy.

Industry group the American College of Obstetricians and Gynecologists’s President Steven Fleischman wrote in a Sept. 22 statement that HHS’s announcement was “highly unsettling” and “not backed by the full body of scientific evidence.”

“In more than two decades of research on the use of acetaminophen in pregnancy, not a single reputable study has successfully concluded that the use of acetaminophen in any trimester of pregnancy causes neurodevelopmental disorders in children,” he wrote.