Donald Trump has proposed restricting paracetamol in pregnancy because of a controversial link to the autism spectrum, prompting a backlash from experts who explain that paracetamol remains safe when used properly.

“Soon, doctors in the US will be advised not to prescribe the painkiller Tylenol to pregnant women,” US President Donald Trump specifically said, citing a controversial link between the drug and the autism spectrum.

The US President made the announcement Monday in the Oval Office, along with Health Secretary Robert F. Kennedy Jr, FDA Commissioner Dr. Marty McCarry, National Institutes of Health Director Dr. Jay Batachariah, and the Administrator of the Centers for Medicare & Medicaid Services, Dr. Mehmet Oz. These announcements were previously announced at Charlie Kirk’s funeral on Sunday.

The US President claimed that taking paracetamol, the main ingredient in Tylenol, also known in the US as acetaminophen, “is not good” and that pregnant women should only take it in cases of severe fever.

In terms of scientific background, some studies have shown a link between Tylenol use during pregnancy and the autism spectrum, but these findings are inconsistent and inconclusive. The company that makes Tylenol, Kenvue, has defended the use of the drug in pregnant women.

In a statement from company representatives to the BBC, they said: “We believe that independent and authoritative science clearly shows that taking paracetamol does not cause autism spectrum. We strongly disagree with any suggestion to the contrary and are deeply concerned about the health risk this poses to expectant mothers.”

Paracetamol – the active ingredient in the drug Tylenol – is the safest painkiller option for pregnant women, they added, and without it, women face a dangerous trade-off between treating conditions like fever or using riskier alternatives.

The company said earlier this month that it had engaged in a “scientific conversation” on the issue with officials from the US Department of Health and Human Services and urged pregnant women to consult their doctor before taking any medication without a prescription.

The conclusions of the scientific studies

Trump on Monday called the rise in reported cases of autism spectrum disorder a “terrible crisis”. However, experts warned that finding the causes of autism spectrum – a complex syndrome that has been researched for decades – will not be a simple task.

The widespread view among researchers is that there is no single cause for autism, which is thought to be the result of a complex combination of genetic and environmental factors.

Different studies have examined the link between paracetamol use during pregnancy and the development of the autism spectrum in children; however, experts say the scientific basis of this theory is not sufficiently proven.

A 2024 study published in JAMA looked at more than 2 million children born in Sweden between 1995 and 2019, of which about 185,000 were born to mothers who took paracetamol during pregnancy. The study compared autism rates among these children with their siblings and with children who had not been exposed, and found that its use during pregnancy was not associated with an increased risk of autism, attention deficit hyperactivity disorder, or other neurodevelopmental disorders.

In addition, a meta-analysis published in August in the journal BMC Environmental Health reviewed 46 studies on paracetamol use during pregnancy and neurodevelopmental disorders in children. Six of the studies specifically looked at paracetamol and autism.

Overall, the analysis concluded that there was “strong evidence of an association” between taking it during pregnancy and the development of autism spectrum disorders in children, but the authors caution that their study can only show associations and not that paracetamol causes the neurodevelopmental disorder.

“We recommend prudent use of paracetamol – the lowest effective dose, the shortest duration – under medical guidance, tailored to individual risk-benefit assessments, rather than a broad restriction,” the researchers wrote.

What the experts say

Dr. Peter Hotez, a pediatrician and co-director of the Vaccine Development Center at Texas Children’s Hospital, said the published evidence on the link between paracetamol and autism “is not particularly convincing.” “We can explain almost all autism spectrum disorders through autism genes. However, some environmental factors in early pregnancy also play a role as they interact with autism genes,” he wrote in a social media post on Sunday.

Dr Monique Botha, professor of social and developmental psychology at the University of Durham, agrees: “There is no strong evidence or conclusive studies to suggest any causal relationship. “Dr Botha added that pain relief for pregnant women is “disappointingly limited”, with Tylenol being one of the few safe options for this population.

FDA notice

After the announcement on Monday, Kennedy said the US Food and Drug Administration (FDA) would issue a notice to doctors about what he described as a potential risk of taking the drug Tylenol during pregnancy. It said the FDA will also begin the process of changing the drug’s safety label and launch a public health campaign to inform the public.

Regarding drug options as a treatment for children on the autism spectrum, the U.S. Secretary of Health and Human Services added that the FDA will soon approve leucovorin, also known as calcium folinate – a derivative of folate – a decades-old drug traditionally used to protect cancer patients from the toxicity of chemotherapy.

For his part, FDA Commissioner Marty McCarthy said the approval will be based on research that he said suggests the drug may help children on the spectrum who are deficient in folic acid (a form of vitamin B) improve their oral communication. Meanwhile, it noted that folic acid supplements have been recommended for decades during pregnancy to prevent neural tube defects, such as spina bifida, in infants.