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SUMMIT, NJ: Global health officials are repudiating President Donald Trump’s unproven medical claim that Tylenol’s active ingredient, acetaminophen, is linked to autism. 

Trump and Health and Human Services Secretary Robert F. Kennedy Jr. issued a warning on Monday claiming that prenatal exposure to acetaminophen is a potential cause of autism.

At a press conference, Trump said on multiple occasions, “don’t take it,” referring to the over-the-counter medication used to treat minor aches and pains and reduce fever, but added that pregnant women could take it if absolutely necessary. 

In response, Kenvue, the company behind Tylenol, said it believes “independent, sound science clearly shows that taking acetaminophen does not cause autism.” 

“We strongly disagree with any suggestion otherwise and are deeply concerned about the health risks and confusion this poses for expecting mothers and parents,” a company spokesperson said via email. “The facts are that over a decade of rigorous research, endorsed by leading medical professionals and global health regulators, confirms there is no credible evidence linking acetaminophen to autism.”

Kenvue, which spun off from Johnson & Johnson in 2023, said it will continue to reinforce that expecting mothers speak to their healthcare providers before taking any over-the-counter medication and will “explore all options to protect the health interests of American women and children.”

Weber Shandwick is the company’s PR partner. A representative from the agency did not say if it is providing crisis support to Kenvue following Trump’s remarks. 

On Monday, the Food and Drug Administration began the process of a label change for acetaminophen in Tylenol to suggest its use by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children. 

“The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen,” FDA commissioner Marty Makary said in a statement. “Even with this body of evidence, the choice still belongs with parents.”

“It remains reasonable, however, for pregnant women to use acetaminophen in certain scenarios,” he added. 

The agency also issued a letter to physicians nationwide recommending pregnant women use the lowest dose for the shortest duration if their doctors determine it’s necessary for pain or fever. 

International health organizations have responded over the past 48 hours, emphasizing that there is no conclusive evidence to support an association between autism and acetaminophen.

European Medicines Agency chief medical officer Steffen Thirstrup said in a statement Tuesday that paracetamol, also known as acetaminophen, remains “an important option to treat pain or fever in pregnant women.”

“Our advice is based on a rigorous assessment of the available scientific data, and we have found no evidence that taking paracetamol during pregnancy causes autism in children,” he said.

The statement said that the organization reviewed studies in 2019 that investigated the neurodevelopment of children exposed to paracetamol in utero and found that no link with neurodevelopmental disorders could be established. 

World Health Organization spokesperson Tarik Jasarevic told reporters in Geneva on Tuesday that “some observational studies” have suggested a possible association between prenatal exposure to acetaminophen, or paracetamol, and autism, “but evidence remains inconsistent.”

Several studies conducted afterward have “found no such relationship,” he said.

“If the link between acetaminophen and autism were strong, it would likely have been consistently observed across multiple studies,” Jasarevic said. “This lack of replicability really calls for caution in drawing casual conclusions about the role of acetaminophen in autism.”

The U.K.’s health regulator, MHRA, also confirmed that taking paracetamol during pregnancy is safe. MHRA chief safety officer Dr. Alison Cave said in a statement that paracetamol remains the recommended pain relief option for pregnant women “when used as directed.”

Australia’s medicines regulator, the Therapeutic Goods Administration, also repudiated Trump’s claim on Tuesday. It said in a statement that the country’s chief medical officer, Michael Kidd, and the TGA “join with other global medicines regulators, leading clinicians and scientists worldwide in rejecting claims regarding the use of paracetamol in pregnancy.”

“Whilst there are published articles suggesting an association between maternal paracetamol use and childhood autism, they had methodological limitations,” the statement said. “More recent and robust studies have refuted these claims, supporting the weight of other scientific evidence that does not support a causal link between paracetamol and autism or ADHD.”

Spain’s health minister, Mónica García Gómez, called out Trump directly for linking paracetamol during pregnancy with autism, “ignoring all medical studies.”

“Denialism not only destroys trust in science: it puts lives at risk,” she said in a post to X. In a follow up post, Gómez added that denialism “only sows alarm and misinformation.”

“Better to listen to health authorities than to the one who suggested injecting bleach against COVID,” she said.

This article originally appeared on PRWeek US.