Trump Warns Against Tylenol In Pregnancy Over Unproven Autism Fears

The Trump administration linked Tylenol to autism and urged pregnant women to avoid the common pain medication despite the lack of widely accepted scientific evidence supporting the risk. 

“So taking Tylenol is not good — I’ll say it — it’s not good. For this reason, they are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary,” President Donald Trump said Monday at a White House event alongside Robert F. Kennedy Jr., his health secretary.

The administration also said it has initiated approval of leucovorin calcium tablets as a new treatment for a condition associated with autism. The drug, also known as folinic acid, is currently used to treat side effects of certain cancer drugs and anemia. 

Monday’s announcement was the latest example of how Kennedy and Trump have sought to upend health guidance and practices, sometimes relying on cherry-picked evidence. Trump also has a record of promoting unfounded medical theories.

The White House didn’t present new evidence to explain the change. Decades of research into autism has failed to identify a single cause. 

Trump went far beyond his public health officials in decrying the effects of acetaminophen, the active ingredient in Tylenol, saying the drug should only be taken by pregnant women in cases of extremely high fever.

“If you can’t tough it out, if you can’t do it, that’s what you’re going to have to do - you’ll take a Tylenol, but it’ll be very sparingly,” Trump said.

Shares of Kenvue Inc., which makes Tylenol, fell 7.5% earlier Monday to close at a record low, though the shares rose 5% in postmarket trading. 

“We believe independent, sound science clearly shows that taking acetaminophen does not cause autism,” Kenvue said in an emailed statement. “We strongly disagree with any suggestion otherwise and are deeply concerned about the health risks and confusion this poses for expecting mothers and parents.”

Tylenol is the company’s largest brand, making up a mid-to-high single digit percentage of Kenvue’s total sales, according to Morningstar analyst Keonhee Kim.

Vaccines for Children

Trump used the event to also criticize vaccine policies for children, suggesting that schedules for shots should be spread out. Trump said he believed children should not be administered shots that address multiple diseases, and said he thought vaccines — such as the one for measles, mumps and rubella, which has been given for more than five decades — should be taken over a long period of time.

“On the vaccines, it would be good, instead of one visit, where they pump the baby, load it up with stuff. You’ll do it over a period of four times or five times,” Trump said. Kennedy has long expressed concerns about the fact that children take more vaccines now than they did in the mid-1980s.

Trump said the National Institutes of Health would also be announcing 13 major grant awards to study autism.

The Food and Drug Administration issued a notice to physicians on Monday about the risk of acetaminophen during pregnancy. The agency recommended doctors “consider minimizing” the medicine for routine, low-grade fevers, while noting that a “causal relationship has not been established” between autism and Tylenol.

Women are typically told to take acetaminophen rather than ibuprofen during pregnancy. The current Tylenol label recommends pregnant or breastfeeding women to speak with a health professional before use. 

Sweeping Advice

The sweeping advice to avoid Tylenol alarmed scientists, who warned that untreated fevers could expose women and babies to greater risks.

“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.

Studies purporting to show a link have failed to account for the fact that fevers themselves increase the risk of autism, the group said.

“It’s very difficult to separate out the effects of the drug from the effects of the reason that people take the drug,” said David Mandell, an epidemiologist at the University of Pennsylvania who studies autism. “I’m very concerned that pregnant women who have fevers will let them go untreated.”

The American College of Obstetricians and Gynecologists called the administration’s moves “irresponsible” and “confusing” to patients. The American Academy of Pediatrics added that sharing misleading information “does a disservice to autistic individuals.”

There have been attempts to link acetaminophen to autism for more than a decade. A 2008 observational study suggested its use to treat fevers in children aged 12 months to 18 months could be associated with an increased likelihood of autism spectrum disorder, though the authors called for more research.

The FDA’s website, updated last month, said the agency “has not found clear evidence that appropriate use of acetaminophen during pregnancy causes adverse pregnancy, birth, neurobehavioral, or developmental outcomes.”

The FDA reviewed the risks of pain medicine use during pregnancy in 2015 and said the data was too limited to make any recommendations. A subsequent 2024 study that analyzed the records of nearly 2.5 million children born in Sweden from 1995 through 2019 found no increased risk of autism when their mothers took acetaminophen while pregnant.

Leucovorin Treatment

Leucovorin is a relatively inexpensive generic drug that’s been around for decades and is currently used to blunt the side effects of chemotherapy for some cancer patients.

The drug’s original manufacturer, GSK Plc, said it will work with regulators on the label update.

In small clinical trials, leucovorin has shown some early promise in improving verbal communication and sociability in children with autism. The children that have responded best to treatment have antibodies that block the brain-cell receptors that respond to naturally occurring folate, according to the nonprofit Autism Speaks, which has funded studies on the drug. 

The FDA said in paperwork posted Monday that the agency conducted a systematic analysis of literature from 2009 to 2024 and determined that the tablets improve some symptoms in patients with cerebral folate deficiency, or CFD, a metabolic disorder that can cause developmental delays and has been linked to a subset of people with autism.

Mandell, of the University of Pennsylvania, said the evidence to support leucovorin as a potential treatment for autism is weak but he supports conducting a large-scale study.

The NIH will research the drug’s impact, including safety studies. The other new projects being funded by the NIH focus on studying whether external factors could impact autism risks including exposure to chemicals and other hazardous substances, nutrition and diet, medications or vaccinations and other health conditions.

State Medicaid programs will be able to cover leucovorin for the indication of autism spectrum disorder, HHS said. The administration expects private insurance programs will follow the government’s lead on coverage.