*

Trump warns against Tylenol use among pregnant women

*

Tylenol maker, scientists say evidence shows claims are

without

merit

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Leucovorin approval based on inconclusive studies, doctors

say

(Adds scientist criticism, updated share moves, researchers on)

By Jeff Mason, Ahmed Aboulenein and Julie Steenhuysen

WASHINGTON, Sept 22 (Reuters) -

U.S. President Donald Trump on Monday linked autism to

childhood vaccine use and the taking of popular pain medication

Tylenol by women when pregnant, elevating claims not backed by

scientific evidence to the forefront of U.S. health policy.

In an extraordinary news conference at the White House, the

Republican president delivered medical advice to pregnant women

and parents of young children, repeatedly telling them not to

use or administer the painkiller and suggesting that common

vaccines not be taken together or so early in a child's life.

The advice from Trump, who acknowledged he is not a doctor,

goes against that of medical societies, which cite data from

numerous studies showing that acetaminophen, the active

ingredient in Tylenol, plays a safe role in the well-being of

pregnant women.

"I want to say it like it is, don't take Tylenol. Don't take

it," Trump said. "Other things that we recommend, or certainly I

do anyway, is ... don't let them pump your baby up with the

largest pile of stuff you've ever seen in your life," he said,

referring to vaccines.

TRUMP ADMINISTRATION BACKS LEUCOVORIN AS TREATMENT

Trump's team suggested leucovorin, a form of folic acid, as

a treatment for autism symptoms.

Dozens of medical, research, and autism advocacy groups,

including the American Academy of Pediatrics and the American

College of Obstetricians and Gynecologists, decried the

president's announcement.

"The data cited do not support the claim that Tylenol causes

autism and leucovorin is a cure, and only stoke fear and falsely

suggest hope when there is no simple answer," the Coalition of

Autism Scientists said in a statement.

Standing with Health Secretary Robert F. Kennedy Jr., a

vaccine critic who has argued that no vaccine is safe, Trump

called for a reexamination of a link between vaccines and

autism, a theory that has been repeatedly debunked.

"We believe independent, sound science clearly shows that

taking acetaminophen does not cause autism. We strongly disagree

with any suggestion otherwise and are deeply concerned with the

health risk this poses for expecting mothers and parents,"

Kenvue ( KVUE ), the maker of Tylenol, said in a statement.

KENVUE SHARES RECOVER IN LATE DAY TRADING

Shares of consumer health company Kenvue ( KVUE ) recovered 5% in

extended trading after slumping more than 7% in Monday's trading

session. The stock remains down about 14% since September 5,

when the Wall Street Journal reported that Kennedy planned to

link acetaminophen to autism. Kenvue ( KVUE ) was spun off from

Johnson & Johnson ( JNJ ) in 2023.

Trump said he is a big believer in vaccines, having led in

his first-term the pandemic initiative to speed COVID-19 vaccine

development. Still, he called for the removal of mercury from

vaccines and said children should not get the hepatitis B

vaccine before the age of 12. It is normally given in the first

24 hours after birth. He also said the measles-mumps-rubella

combination vaccine should be split into three separate shots.

The Tylenol-autism link announcement was reminiscent of

Trump's regular press briefings in the early months of the

pandemic, when he would frequently dispense advice that was not

founded on science, including his suggestion that people ingest

bleach, which his supporters later said was not serious.

Studies have shown vaccines are safe, eradicating childhood

diseases such as polio and measles in the U.S. Over the last 50

years, it is estimated that essential vaccines have saved at

least 154 million lives, UNICEF USA President & CEO Michael J.

Nyenhuis has said.

Only one in four Americans believe recent recommendations

for fewer vaccines from the Trump administration were based on

scientific evidence and facts, a Reuters/Ipsos poll showed this

month.

"I cannot say that I've ever experienced anything like this

in vaccines," said Dr. Norman Baylor, former director of the

FDA's Office of Vaccines Research and Review.

TRUMP ADMINISTRATION ANNOUNCES STEPS IT WILL TAKE

The Trump administration has asked drug companies to be

prepared to ramp up production of leucovorin as a treatment for

some autism patients, Food and Drug Administration chief Marty

Makary told reporters.

The FDA approved a version of the drug made by GSK

, aimed at treating a condition associated with autism,

but which the drugmaker no longer manufactures. Once it is

established for the use, the administration said Medicaid

insurance for low-income people would cover the drug for autism

symptoms.

The FDA, in its approval process, cited a review of the use

of leucovorin in 40 patients with a rare metabolic disorder

called cerebral folate deficiency that can lead to a range of

neurological symptoms, some of which are seen in people with

autism.

The FDA said it would seek a label change for

over-the-counter Tylenol and its generic versions to reflect

evidence suggesting that use during pregnancy may be associated

with an increased risk of neurological conditions such as autism

and ADHD in children. The FDA also sent a letter to doctors with

a similar warning, but said a causal relationship had not been

established.

RESEARCHERS SAY THERE IS NO CAUSAL LINK

Researchers say there is no firm evidence of a link between

the use of Tylenol and autism. A 2024 study of nearly 2.5

million children in Sweden found no causal link between in utero

exposure to acetaminophen and neurodevelopmental disorders.

A 2025 review of 46 earlier studies did suggest a link

between prenatal acetaminophen exposure and increased risks of

these conditions, but the researchers from the Icahn School of

Medicine at Mount Sinai, Harvard University and others said the

study does not prove the drug caused the outcomes.

They advised that pregnant women should continue to use

acetaminophen as needed, at the lowest possible dose and for the

shortest possible period. Trump officials cited that review and

used similar language in advising how much Tylenol to take.

"It is clear that the Tylenol-autism link is not a new

question - it has been looked at many times and in many

different studies," autism researcher Dr. Diana Schendel of the

A.J. Drexel Autism Institute said in a statement, noting that

she would like to see what new evidence the administration comes

up with. "Without showing any evidence to back them up, the

announcements become reckless and potentially harmful."

Researchers say leucovorin, used to treat some cancer

patients on chemotherapy, has shown some promise in very small

trials, but that large, randomized trials are still needed.

"There's not good evidence that it works. There are some

studies, but they're small and they're not the best studies. And

so it's certainly not something I'm actively recommending," said

Dr. Audrey Brumback, an autism expert and researcher at the

University of Texas at Austin.