Speaking in the Oval Office and flanked by top health officials, Trump on Monday said pregnant women shouldn't take acetaminophen because of the risk of autism, except in case of an extremely high fever — "if you can't tough it out."
"Taking Tylenol is, uh, not good. I'll say it. It's not good," Trump said.
He claimed repeatedly that "there's no downside" to not taking it.
Many researchers have cautioned that there is no causal link between the use of acetaminophen while pregnant and autism, and data showing a potential link are not clear.
Tylenol has been one of the only over-the-counter pain medications for pregnant women that is considered safe. Other options like ibuprofen or aspirin can increase risks of birth defects.
The American College of Obstetricians and Gynecologists (ACOG) warned there would be real-world consequences from the administration's move, calling it "irresponsible."
"The conditions people use acetaminophen to treat during pregnancy are far more dangerous than any theoretical risks and can create severe morbidity and mortality for the pregnant person and the fetus," ACOG president Steven J. Fleischman said.
Kenvue, maker of Tylenol, disputed the idea of any link.
"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. We stand with the many public health and medical professionals who have reviewed this science and agree," the company said.
"We will continue to reinforce that expecting mothers speak to their health professionals before taking any over-the-counter medication and will explore all options to protect the health interests of American women and children."
Trump and his health officials also announced they would be recommending leucovorin, a form of the B vitamin folic acid, as a way of treating autism symptoms. The Food and Drug Administration is initiating its approval for cerebral folate deficiency, which has some potential links to autism spectrum disorders.
Leucovorin is used to treat side effects of chemotherapy.
The Coalition of Autism Scientists said it does not support this recommendation.
"There are only a handful of clinical trials of leucovorin and evidence connecting treatment to improvements in outcomes is very weak," said the group. "All of them are very small, and the study designs and approaches to statistical analyses of the data are not all of high quality. It is premature to claim that leucovorin is an effective treatment for autism and add autism as a secondary indication."
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