Trump sparks row with unproven Tylenol-autism link, HepB vaccine scheduling

At White House press meet, Trump said Tylenol use in pregnancy may cause autism and also called for delaying Hep B vaccines; experts warn unproven claims risk fuelling confusion, vaccine hesitancy

At a White House press conference on Monday, US President Donald Trump made claims linking the common painkiller Tylenol (acetaminophen) to an increased risk of autism and announced new Food and Drug Administration (FDA) regulatory guidance alerting physicians about the same. However, during his announcement at the White House, he made these claims without giving new evidence to prove those.

 

Trump also called for delaying the Hepatitis B vaccine for children during the conference.

 

Trump’s announcement comes as the latest step of his administration, driven by United States Secretary of Health and Human Services Robert F Kennedy Jr and his ‘Make America Health Again’ campaign to reshape America’s public health landscape. However, his remarks quickly drew sharp criticism from medical experts, who warned that such statements risk fuelling confusion and undermining evidence-based medical guidance.

 

What Trump claimed

Tylenol (acetaminophen) and autism risk

Trump said that pregnant women should avoid Tylenol unless absolutely necessary, for example, in the case of a very high fever. He called Tylenol “not good.”  The generic name for Tylenol is paracetamol, and in India it is sold under many brand names, the most popular being Crocin and Dolo 650.

 

Trump claimed that there is a link between prenatal acetaminophen use and neurodevelopmental disorders such as autism and ADHD.

 

“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,” said Trump during the presser.

 

He added, “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.” 

"Some 40-70% of mothers who have children with autism believe that their child was injured by a vaccine. President Trump believes that we should be listening to these mothers instead of gaslighting and marginalizing them like prior administrations." - @SecKennedy pic.twitter.com/491tqIpgKy

— The White House (@WhiteHouse) September 23, 2025

Vaccine scheduling, including Hepatitis B

He also suggested that some vaccines are given too early or together in ways he and RFK consider excessive. He urged that vaccine shots be spread out over a longer period such as breaking up combination vaccines like the combined measles, mumps, rubella, and varicella (MMRV) shot.

 

“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.

 

He also called for the removal of vaccine ingredients like mercury and aluminium, and for splitting certain combined vaccines.

 

He specifically proposed that the Hepatitis B vaccine, currently given to newborns (often within the first hours after birth), be delayed until later when children are older.

 

During the presser, Trump said, “I would say, wait until the baby is 12 years old and formed,” when talking about vaccinations for children.

Policy and regulatory moves announced

The FDA is going to update the labelling of acetaminophen/Tylenol (and its generic equivalents) to reflect that use during pregnancy may be associated with increased risk of autism or neurodevelopmental disorders.

 

The FDA also issued a notification on Monday to physicians warning that the use of Tylenol “can be associated” with an increased risk of autism. The agency recommended doctors “consider minimising” the medicine for routine, low-grade fevers, while noting that a “causal relationship has not been established” between autism and Tylenol.

 

The Health Secretary said that he would be launching an “all-agency” effort to identify all causes of autism, involving the National Institutes of Health, the FDA, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services, at the direction of President Trump. 

President Donald J. Trump, @SecKennedy, @DrOzCMS, @NIHDirector_Jay, & @DrMakaryFDA announce the Autism Action Plan.  Make America Healthy Again. pic.twitter.com/1inEvIecYU

— The White House (@WhiteHouse) September 22, 2025

US regulator approves drug for autism treatment

In a related move, the Trump administration, with Health Secretary RFK, announced steps to approve leucovorin (a form of folinic acid) as a treatment for autism symptoms.

What experts say

On acetaminophen and autism risk

Medical societies like the American College of Obstetricians and Gynecologists continue to state that acetaminophen, when used as directed, remains a generally safe option during pregnancy, especially compared to risks of untreated high fever or pain. They 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.”

 

Experts say the link between prenatal acetaminophen use and autism is not proven. According to them, many studies find associations (correlations), but do not establish causation.

 

For example, a large Swedish cohort study (nearly 2.5 million children, 1995–2019) found no increase in risk of autism, ADHD, or intellectual disability in analyses.

 

A recent review of 46 earlier studies found mixed results: some report an association, others do not. It is important to note here that differences in study design, dosage, exposure timing, and confounding factors make interpretations difficult.

 

“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.

On Hepatitis B timing

Experts warn that delaying the Hepatitis B vaccine after birth, as Trump and RFK suggested, could leave infants at risk of infection, particularly since perinatal transmission is one of the major routes of Hepatitis B spread. Early vaccination (within 24 hours) is standard in many guidelines including India’s.

 

Research and public health consensus strongly support current vaccine schedules. Spreading out vaccines or delaying them without solid evidence may increase vulnerability to preventable diseases.

On leucovorin as treatment

Leucovorin, originally manufactured by GSK Plc, is being proposed based on small studies and anecdotal data and is not established in larger, rigorous clinical trials as an autism treatment. Experts caution about premature claims.

 

There is concern that presenting leucovorin as a relatively imminent or standard treatment could give false hope or distract from more robust, evidence-based interventions.

 

Trump sparked a row on public health guidance with his Monday announcement which prompted many experts to come forward on social media including X to call for evidence-based guidance to balance risks and causes. They said that Tylenol is among the few pain/fever medicines considered relatively safe and overemphasising possible harms might discourage use even when medically necessary.

 

They stressed that standard vaccination schedules are based on decades of epidemiological data, balancing efficacy, safety, and disease risk and delaying vaccines can reduce early immunity and increase chances of disease outbreaks.

 

They also urged pregnant people and parents to consult medical professionals rather than rely solely on political statements. Medical bodies still recommend following existing guidelines and using acetaminophen when necessary, with medical oversight.

Prevalence of autism

The US has a higher reported prevalence of autism spectrum disorder (ASD). The Centers for Disease Control and Prevention (CDC) reported that 1 in 36 children in the US were identified with ASD as of 2020.

 

According to an April 2024 paper in Indian Pediatrics, the estimated prevalence in India is lower, with figures around 1 in 68 children aged 2–9 years. However, the paper said that this lower rate is likely due to systemic challenges such as a lack of widespread diagnostic tools, less awareness about autism, and delayed diagnosis.

 

Globally, according to the World Health Organization (WHO), about 1 in 127 persons had autism, as estimated in 2021.