Paracetamol joins vaccines on Trump’s hitlist as he links painkiller to autism despite lack of evidence

US President Donald Trump has controversially linked the use of the common painkiller paracetamol with autism, sparking strong pushback from Australian experts and health regulators.

Mr Trump, flanked by Health Secretary Robert F Kennedy Jr in the Oval Office, said doctors in America would soon be advised not to prescribe Tylenol, which contains paracetamol, to pregnant women.

“Don’t take Tylenol. Don’t take it. Fight like hell not to take it,” Mr Trump said.

He urged expectant mums to “tough it out” when in pain.

The comments, which had been anticipated in recent days, triggered strong pushback from many in the science and medical community who said the move was unsupported by evidence.

It’s also at odds with advice from Australia’s Therapeutic Goods Administration — and which on Tuesday rejected the claims of links between paracetamol use by pregnant women and autism or ADHD in children.

“Paracetamol remains the recommended treatment option for pain or fever in pregnant women when used as directed,” the TGA said in a statement. “Importantly, untreated fever and pain can pose risks to the unborn baby, highlighting the importance of managing these symptoms with recommended treatment.”

American scientists have previously sounded the alarm at the administration’s increasingly anti-vaccine stance.

Mr Kennedy touted a potential cure for autism in the B-vitamin-based drug, Leucovorin, which he said the Food and Drug Administration would soon approve as a treatment for children with autism.

Again, experts said there was limited evidence to support its efficacy and more studies were needed.

Both Mr Trump and Mr Kennedy hinted at a vaccine link to autism, despite many studies debunking an association, while foreshadowing “a massive testing and research effort” into the root cases of autism.

Mr Trump said infants were being loaded up with too many vaccines.

Critics said the president’s statements were dangerous and reminiscent of his first-term advocacy of unproven treatments, including injecting disinfectant, for COVID.

Here’s how Australian experts rebuffed the US stance:

Therapeutic Goods Administration statement

“The TGA is aware of announcements by the US Administration that use of paracetamol in pregnancy may be associated with an increased risk of autism and ADHD in children, though a causal association has not been established.

“TGA advice on medicines in pregnancy is based on rigorous assessment of the best available scientific evidence. Any new evidence that could affect our recommendations would be carefully evaluated by our independent scientific experts.

“Whilst there are published articles suggesting an association between maternal paracetamol use and childhood autism, they had methodological limitations. More recent and robust studies have refuted these claims, supporting the weight of other scientific evidence that does not support a causal link between paracetamol and autism or ADHD.”

Professor Andrew Whitehouse, the Angela Wright Bennett Professor of Autism Research at The Kids Research Institute Australia:

“At best, this is misleading. At worst, it’s a complete misuse of science.

“The link between paracetamol and autism has been studied for over a decade now, and there are absolutely some findings that show that if you take paracetamol during pregnancy, there is a small, weak association to an increased chance of that pregnancy being diagnosed with autism. But there are also studies that show no association, and there are also even studies that show the reverse, that taking paracetamol might reduce the chances of the child being diagnosed with autism.

“But critically, what none of these studies show is a causal link, that paracetamol during pregnancy is causal of autism in the offspring of that pregnancy, and that’s why I say it’s a misuse of science.”

“Autism is a complex condition influenced by many genetic and environmental factors. Any small associations in this area need to be weighed against the risk of untreated high fever in pregnancy for the woman and the developing baby,” Professor Whitehouse added.

Professor Gino Pecoraro, President of the National Association of Specialist Obstetricians and Gynaecologists

“This comment by the US President is not helpful and has the potential to cause unnecessary anxiety for pregnant women and their families.

“Numerous studies have found association between paracetamol use and Autism spectrum disorder but none have found causation.

“Even in the studies suggesting association, the effect is very mild with only a 0.1 per cent increased rate in the largest Swedish study looking at 2.5 million children born between 1995 and 2019.

“These changes were more likely explained by confounding issues rather than drug having been taken. Furthermore, twin studies of fraternal twins whose mothers had taken paracetamol during pregnancy did not find concordance with very few cases that both twins were affected.

“Paracetamol remains a very effective treatment for pain and fever and to remove this from pregnant women would be to do them a disservice. It is important to control these symptoms in pregnancy as they may cause problems of themselves.”

Dr Hannah Kirk, senior lecturer in the Turner institute for Brain and Mental Health at Monash University

“Autism is a neurodevelopmental condition with no known single cause. However, research shows that genetics play a large role, with hundreds of genes being linked to autism. Recent suggestions that Tylenol use during pregnancy could increase the risk of autism has understandably raised concern among expectant parents.

“However, no study has shown that acetaminophen, the main ingredient in Tylenol, causes autism. Some studies have reported an association between acetaminophen (paracetamol) use and autism, while others have not. Importantly, association does not mean causation.

“A recent large-scale study, which analysed data from 2.48 million births, found that when researchers compared siblings (a method to control for genetic and environmental factors) any apparent links between acetaminophen and autism disappeared. This suggests that other factors such as genetic or underlying maternal health conditions may better explain the findings.

“It’s also worth noting that fever itself has been linked to adverse pregnancy outcomes. In many cases treating a fever with acetaminophen may reduce those risks. Pregnant people should continue to follow the advice of their healthcare providers when managing pain and fever.”

Dr Ian Musgrave, senior lecturer in the Faculty of Medicine at the University of Adelaide

“Autism was described in 1943 and paracetamol was not commercially available in the US until 1950, and Australia in 1956.

“After decades of research we know that autism is a multigenomic developmental disorder, with 80 per cent hereditability. Environmental factors are involved as well, such as parental age, and fever during pregnancy.

“However, we have strong evidence paracetamol is not associated with autism ... There has been some alarm in the general public about the increasing incidence of autism in the population, but this is due to increased awareness amongst parents and clinicians and broadening diagnostic substitution.

“There is a temptation to seek simple answers to complex problems like autism, but blaming paracetamol will not help and will only cause parents unwarranted anxiety. Remember that fever during pregnancy is a risk for autism and poor pregnancy outcomes generally, and demonising one of the few agents available to women during pregnancy will not improve outcomes.”

Associate Professor Alex Polyakov, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne

“The balance of evidence indicates that prolonged or high-dose use of paracetamol during pregnancy may carry risks for the child, whereas occasional or short-term use is unlikely to be harmful.

“This conclusion aligns with a broader principle in medicine: all medications should be used cautiously, only when clearly necessary, at the lowest effective dose, and for the shortest possible time. This guidance is particularly important in pregnancy, when many alternatives to paracetamol for pain and fever management have well-established risks that are considerably greater.

“Research shows that both autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) are predominantly driven by genetic factors, which account for around 70–80 per cent of overall risk, while environmental influences together contribute only about 20–30 per cent.

“Among these environmental factors, many influences are involved — such as parental age, prematurity, maternal health conditions, and air pollution — each contributing only modestly. Any effect of paracetamol use in pregnancy is therefore likely to be very small relative to these much larger genetic influences.

“This means that even if paracetamol was completely eliminated during pregnancy, it would almost certainly have only a negligible impact on the overall prevalence of ADHD and ASD at the population level.”

Professor Adam Guastella, Clinic for Autism and Neurodevelopment research at the University of Sydney

“The evidence about the use of leucovorin as a treatment for autism, either provided in pregnancy or to children with autism, is preliminary and requires stronger scientific studies to ensure safety and effectiveness. There are some promising studies suggesting possible benefits, but these studies have many limitations that suggest that further research is needed. They are not at the quality that is needed for widespread use.

“There are also some studies suggesting negative side effects. More work is needed to be certain about the correct dose and timing, particularly when given in pregnancy and early childhood, before being taken up as a treatment for the community.”

Professor Dawn Adams, Endowed Chair in Autism Research at La Trobe University

“The suggestion of using leucovorin to ‘treat’ autism is worrying. Firstly, because the research in this area is poor quality and not at the level that we would expect when making recommendations for approvals. It is also worrying because such statements impact how people understand and perceive autism.

“Autism is not something that needs treating or to be cured, it’s a neurodevelopmental difference. When we frame it as a condition that needs ‘fixing’, we risk adding to the stigma autistic people already face.

“What really makes a difference for autistic people is the right supports: inclusive classrooms, workplaces that adapt to needs, communities that understand communication and sensory differences, and policies shaped by good-quality research. These are the things that help autistic people thrive and the things that governments have the opportunity to create.

“Autistic people don’t need treatments or cures. They need a world that accepts and values them for who they are.”

Professor Andrew Cashin, Autism researcher at Southern Cross University

“On the basis of limited evidence in the US, Trump and Kennedy announced a plan to combat what they describe as an autism epidemic. Autism is framed as part of an explosion in chronic childhood disease.

“While it is clear the evidence related to the role played by Tylenol and Folate in the causation of autism is tentative at best, perhaps the more significant impact internationally is the shift in the narrative related to autism.

“There is a marked difference from the generally held view of autism as a neurotype that forms part of human diversity to one of chronic disease and/or disability. For those with Autism Spectrum Disorder the importance of a mix of not only individual supports, but also reasonable adjustments, to promote wellbeing and functioning, is changed to a discussion of autism as a disease and disability that needs treatment.”

Australian Medical Association President Dr Danielle McMullen

“Like all medications, we try to use as little as possible when pregnant, but certainly for pain or fever in pregnancy, the advice here in Australia still is that paracetamol is a reasonable option and a safe option for pregnant women to use.”