Australian doctors and medical experts have pushed back against claims made by US President Donald Trump linking the use of popular over-the-counter pain medication Tylenol, also known as paracetamol, and the development of autism during pregnancy.
Paracetamol remains 'Pregnancy Category A' in Australia, meaning that it is considered safe for use in pregnancy. The most popular paracetamol brand name in Australia is Panadol.
Trump used a White House event on Tuesday to announce that the US Food and Drug Administration (FDA) will tell doctors to advise pregnant American women against using Tylenol, known as acetaminophen, because of an increased risk of autism. He did not present evidence for the claim.
Trump also suggested leucovorin, a form of folic acid, as a treatment for autism symptoms.
US President Donald Trump did not provide evidence during his White House announcement around paracetamol and autism links. Credit: Francis Chung/POOL/EPA
Experts say there is no firm evidence of a link between the use of Tylenol — widely known as paracetamol outside the US — and autism. They say leucovorin, used to treat some cancer patients on chemotherapy, has shown some promise in very small trials, but that large, randomised trials are still needed.
What is Tylenol?
Tylenol is an American brand of paracetamol and has the same main ingredient, acetaminophen. Tylenol is made by consumer health company Kenvue, which was spun off from Johnson & Johnson in 2023.
Kenvue said on Tuesday any claimed link between its product and autism was not based on science.
Paracetamol is one of the most common over-the-counter medicines in Australia and around the world.
Pregnant women in Australia are advised that they "can use paracetamol to help with mild to moderate pain during pregnancy", and this advice remains unchanged.
Paracetamol safe to use in pregnancy, TGA says
In a statement on Tuesday, the Therapeutic Goods Administration (TGA) said it was aware of the US administration's announcement, but rejected claims that the use of paracetamol in pregnancy posed a risk of the development of autism and ADHD in children.
"Robust scientific evidence shows no causal link between the use of paracetamol in pregnancy and autism or ADHD, with several large and reliable studies directly contradicting these claims," the medicines regulator said.
Health Minister Mark Butler had tasked the TGA with providing "some very quick advice" on the use of the active ingredient in Panadol and Tylenol during pregnancy in anticipation of Trump's announcement.
The TGA had earlier told SBS News in a statement: "Paracetamol remains Pregnancy Category A in Australia, meaning that it is considered safe for use in pregnancy."
"The TGA has no current active safety investigations for paracetamol and autism, or paracetamol and neurodevelopmental disorders more broadly.
"When safety signals are identified for a medicine, they are subject to detailed clinical and scientific investigation to confirm that a safety issue exists, and if confirmed, what regulatory actions are most appropriate to mitigate the risk.
"The use of medications in pregnancy is subject to clinical, scientific and toxicological evaluation at the time of registration of a medicine in Australia.
"The TGA maintains robust post-market safety surveillance and pharmacovigilance processes for all medicines registered in Australia, including paracetamol. This includes detailed analysis of adverse event reports made by medicine consumers, clinicians and pharmaceutical companies, review of published medical literature, and close liaison with international medicines regulators."
What evidence is there to link paracetamol with autism?
A recent scientific review by researchers at Harvard University and the Icahn School of Medicine at Mount Sinai in New York explored the association between paracetamol and autism.
Andrew Whitehouse, an autism researcher who is deputy director of the Kids Research Institute Australia, said researchers involved in that project reviewed all the studies in the area that have looked at whether taking paracetamol during pregnancy increases the likelihood that the offspring of that pregnancy has a neurodevelopmental condition such as autism or ADHD.
Andrew Whitehouse says while some studies have proven an association between paracetamol taken during pregnancy and a slight increase in the chance of autism in offspring, causation has not been proven. Credit: .
"What that study found, which is replicating previous systematic reviews in this area, is that taking paracetamol during pregnancy slightly, in a very, very small way, increases the chances that the offspring may receive a diagnosis of autism or ADHD," Whitehouse said.
"It's really important to put this in context. What they identified is about a 20 per cent increased likelihood above the population rate — so, in relation to autism, this means that the rate goes from the chances an offspring might have a diagnosis of autism from 1 per cent up to 1.2 per cent."
An association does not necessarily mean one thing has caused the other, so more research would be needed to prove what the 0.2 per cent increase was caused by.
Whitehouse said there was potential that the reasons women were taking paracetamol in the first place led to the slightly increased prevalence of autism in the children of those women.
"People take paracetamol during pregnancy because they might have a fever, or they might have pain. What we do know is that a fever or other illness during pregnancy in and of itself, particularly a severe fever, can increase the likelihood of offspring having neurodevelopmental differences, and it's extremely hard to disentangle this through the study," he said.
A major 2024 Swedish study found no association between use of paracetamol in pregnancy and risk of autism, ADHD or intellectual disability.
The study looked at nearly 2.5 million children born in the country between 1995 and 2019, with nearly 186,000 children exposed to paracetamol in pregnancy.
"[The study] found that when researchers compared siblings (a method to control for genetic and environmental factors) any apparent links between acetaminophen and autism disappeared," Dr Hannah Kirk, a senior lecturer in the Turner Institute for Brain and Mental Health at Monash University, said.
"This suggests that other factors such as genetic or underlying maternal health conditions may better explain the findings."
On Tuesday, the TGA said articles suggesting an association between maternal paracetamol use and childhood autism 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," it said.
What is known to cause autism?
Identifying the root of autism — a complex condition connected to brain development that many experts believe occurs for predominantly genetic reasons — has been a pet cause of Trump's health chief, Robert F Kennedy Jr.
Kennedy has for decades spread debunked claims that vaccines cause autism.
Kirk said there was no known single cause of autism.
"However, research shows that genetics play a large role, with hundreds of genes being linked to autism," she said.
Autism is a neurodevelopmental condition that can affect a person's communication, sensory sensitivity and social interactions and may present in obsessive interests or repetitive behaviours. Source: Getty / dragana991
Trump administration's suggestion
The Trump administration also suggested leucovorin, a form of folic acid, as a treatment for autism symptoms.
The FDA approved a version of the drug made by GSK, which it had previously withdrawn for a condition it associated with autism.
The FDA, in its approval, 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.
Whitehouse from the Kids Research Institute said there was no evidence that leucovorin could treat autism.
Leucovorin acts in the same way as folic acid does in the body and is used as an antidote to the harmful effects of cancer medicine.
"It is so preliminary to identify any kind of biological agent as an intervention for autism, and it is highly misleading to say otherwise," he said.
"There have been a small number of very small studies that have investigated this as a potential biological intervention for autism.
"It doesn't meet any threshold of any kind of standard level of science to indicate that this should be used other than for further research."
'Nothing burger': Calls for more funding and research
Nicole Rogerson, director and CEO of Autism Awareness Australia, said many in the autism space had viewed the US plan to find "the cause" of autism in a number of months perplexing, given decades of research had failed to do so.
Before the Trump administration's expected announcement, Rogerson told SBS News: "If the special secret sauce is a tenuous link to pregnant women taking Tylenol, it will be absolutely what it is and a nothing burger."
She said such an announcement just added "a lot of poor science into an area that actually does need a lot more research, it does need a lot more focus".
Nicole Rogerson from Autism Awareness Australia says more research needs to be done into autism in Australia. Source: Supplied
'Inherently sexist'
Whitehouse said it was disappointing that autism was being used as a "plaything for culture wars".
"Kids who are struggling in their day-to-day environment, families who are struggling to support the person they love more than anything in the world and here we are wasting precious attention, energy and effort, focusing on things that will not make a single difference in their lives," he said.
David Tonge is the chief executive of Amaze, the peak body for people with autism and their supporters.
The head of Amaze, David Tong, says the debate around taking paracetamol in pregnancy and autism rates was not helpful. Source: Supplied
"The framing of this, from a behavioural perspective, is inherently sexist as it ties decisions of a mother to the potential disability of her child," he said.
"This is an insidious line of discussion that is hurtful to mums."
— With additional reporting by Reuters
