Health experts from around the globe are joining the chorus of doctors and organizations pushing back against the Trump administration’s announcement Monday linking the use of acetaminophen — the active ingredient in Tylenol and many cold and flu medications — during pregnancy to an increased risk of autism in children.
“Effective immediately, the FDA will be notifying physicians that the use of acetaminophen during pregnancy can be associated with a very increased risk of autism,” President Trump said at a news conference with Health and Human Services Secretary Robert F. Kennedy Jr. and others.
In a statement Tuesday, the European Union’s European Medicines Agency said there is currently “no new evidence” that would require changes to the current EU recommendations for use of acetaminophen, also commonly called paracetamol outside the U.S.
“Paracetamol remains an important option to treat pain or fever in pregnant women,” Steffen Thirstrup, EMA’s chief medical officer, said in the statement. “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.”
The United Kingdom’s Medicines and Healthcare products Regulatory Agency said Tuesday, “taking paracetamol during pregnancy remains safe.”
“There is no evidence that taking paracetamol during pregnancy causes autism in children,” the agency’s chief safety officer Dr. Alison Cave said in the statement.
In a combined statement, Australia’s chief medical officer and the country’s medicine regulator, the Therapeutic Goods Administration, said they were joining “other global medicines regulators, leading clinicians and scientists worldwide in rejecting claims regarding the use of paracetamol in pregnancy, and the subsequent risk of development of ADHD or autism in children.”
“Robust scientific evidence shows no causal link between the use of paracetamol in pregnancy and autism or ADHD, with several large and reliable studies directly contradicting these claims,” the statement continued.
While sharing a statement from Spain’s Ministry of Health that stated paracetamol can be used during pregnancy, the country’s minister of health, Mónica García, called out Mr. Trump specifically for misinformation and lack of evidence.
“Trump’s new crusade is against paracetamol during pregnancy, ignoring all scientific evidence,” she wrote on X. “This denialism only sows alarm and misinformation. It’s better to listen to health authorities than to the person who suggested injecting bleach against COVID,” referring to a remark Mr. Trump made in 2020.
A World Health Organization spokesperson said Tuesday that evidence of a link between the use of paracetamol during pregnancy and autism “remains inconsistent,” according to Reuters.
International-based studies have been part of the evidence that shows acetaminophen use during pregnancy is safe.
In a major study published last year, for example, researchers followed nearly 2.5 million children in Sweden over 25 years and found that acetaminophen use during pregnancy did not increase the risk of neurodevelopmental disorders in children.
In the U.S., organizations — including one that represents those who treat pregnant patients, the American College of Obstetricians and Gynecologists — have countered the claimed link, saying there’s “no clear evidence.”
The Consumer Healthcare Products Association, which represents some of the largest makers of over-the-counter medications, including acetaminophen, said, “Safety is the top priority for manufacturers,” and “the well-established profile of acetaminophen is supported by decades of research and real-world use.”
And the Autism Science Foundation said in a statement that any association between acetaminophen and autism is based on “limited, conflicting, and inconsistent science.”