The Food and Drug Administration (FDA) announced on Monday that it has begun the process of changing the labeling on acetaminophen to indicate that it may be linked to autism and ADHD in children whose mothers took the common pain reliever during pregnancy.
This announcement came shortly after President Trump, speaking from the White House, urged pregnant women to avoid taking Tylenol. “Don’t take Tylenol,” he repeated. “Fight like hell not to take it,” Trump said.
Acetaminophen, commonly sold as Tylenol, has been available over-the-counter in the U.S. for decades as a pain reliever and fever reducer. It is one of the few easily accessible options for pregnant women seeking relief from pain.
However, the new guidance from the Trump administration contradicts the positions of numerous medical societies and organizations, which maintain that current scientific evidence does not support a causal link.
“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 causes neurodevelopmental disorders in children,” said Steven Fleischman, president of the American College of Obstetricians and Gynecologists (ACOG), in a statement on Monday.
On Tuesday, President Trump further encouraged parents to avoid giving acetaminophen to their children, though he admitted some uncertainty. When asked about organizations like ACOG pushing back against his claims, Trump replied, “You know what? Maybe they’re right.”
He added, “I don’t think they are, because I don’t think the facts bear it out at all. They’re fighting for something that, in my opinion, they shouldn’t be fighting for.”
“But here’s the thing, there’s no downside to doing — other than a mother will have to, as I say, tough it out a little bit.”
FDA Commissioner Marty Makary weighed in on the issue, stating, “The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen.”
He emphasized that “even with this body of evidence, the choice still belongs with parents.” Makary noted that the precautionary principle might lead many to avoid using acetaminophen during pregnancy, especially since most low-grade fevers do not require treatment. However, he added, “It remains reasonable for pregnant women to use acetaminophen in certain scenarios.”
Health and Human Services Secretary Robert F. Kennedy Jr. has pledged to identify a cause of autism by September of this year. Meanwhile, the FDA pointed out that a causal relationship between acetaminophen and neurodevelopmental conditions has not been confirmed.
The agency underscored that their move is based on a possible correlation between acetaminophen use and diagnoses of autism and ADHD. “It is important to note that while an association between acetaminophen and neurological conditions has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature,” the FDA said.
In response to the White House’s statements, Tylenol manufacturer Kenvue strongly disputed any suggestion that their product causes autism.
“We believe independent, sound science clearly shows that taking acetaminophen does not cause autism,” the company said.
“We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers.”
Kenvue emphasized that acetaminophen remains the safest pain reliever option for pregnant women when needed throughout pregnancy. Without it, women may face dangerous choices—either suffering through conditions like fever, which can be harmful to both mother and baby, or resorting to riskier alternatives.
https://wgntv.com/news/fda-initiates-label-change-on-tylenol-to-warn-of-autism/
