The US Trump administration’s advice that pregnant women should limit the use of acetaminophen — also known as paracetamol — because of links to autism in children has been broadly condemned as “baseless” and causing unnecessary fear.
The announcement was made in a blaze of fanfare, with US President Donald Trump teasing the details hours before by boldly declaring: “I think we found an answer to autism.”
Many experts in the US and across the globe moved swiftly to criticise the announcement, noting there was no robust evidence to suggest taking paracetamol during pregnancy could increase the likelihood of a child being diagnosed with autism.
Some told the ABC it was a “completely exaggerated reading of science” with “categorically no evidence” behind it.
Closer to home, the Australian government said it was looking “very closely” at the details, while urging any pregnant women who were concerned to seek medical advice.
So what exactly are the details of this announcement, and does it change anything for pregnant women in Australia?
Let’s take a closer look.
First things first, what exactly was in this announcement?
The main component of today’s announcement was the recommendation that pregnant women should limit the use of acetaminophen because of concerns about links with autism.
Experts say these links are dubious and the evidence to support them is inconclusive — but more on that a bit later.
Trump administration links pregnant paracetamol use to autism risk
In April, health secretary Robert F Kennedy Jr ordered the Department of Health and Human Services to conduct an investigation into the causes of autism.
Today he stated the US Food and Drugs Administration (FDA) would issue a physician’s notice about the “risk of acetaminophen during pregnancy” and change the safety labels on packaging for products sold in the US like Tylenol.
Mr Kennedy said clinicians should use their “best judgement” by prescribing the lowest effective dose for the shortest amount of time.
Is acetaminophen the same as paracetamol?
Yes.
Acetaminophen is known as paracetamol here in Australia — but it’s the same thing.
You might have heard Americans talk about the brand name Tylenol — acetaminophen is the active ingredient.
Acetaminophen — or paracetamol — is one of the most widely used medicines around the world.
Is there a link between paracetamol and autism?
Scientists have long investigated potential associations between using acetaminophen during pregnancy and developmental disabilities.
But while some studies have suggested a link, a broad range of experts argue there’s no conclusive evidence to support it, like Dr Elisha Broom, a maternal-fetal medicine specialist at The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG).
She said studies struggled to exclude factors like genetics or environment, as well as the possibility that the reason a woman is taking acetaminophen — for fever or infection for example, could be what affects the mental development of the child.
Dr Broom said the gold-standard study in this area, published last year in the Journal of the American Medical Association, studied more than two million children in Sweden and was able to better control external factors.
It compared siblings and found no association between acetaminophen use during pregnancy and the risk of autism, ADHD or intellectual disability.
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More recent research from the School of Medicine at Mount Sinai in New York had a different conclusion — it analysed 46 studies from multiple countries and found there was an association, but Dr Broom said variables weren’t adequately controlled.
Crucially, the American researchers advised pregnant women could still safely use acetaminophen at the lowest dose for the shortest possible amount of time.
“We’re very comfortable that the balance of risk and benefit absolutely leans heavily to the side of benefit, “Dr Broom said.
What’s been the reaction?
Experts from across the board have criticised the announcement.
Professor Andrew Whitehouse, Deputy Director of The Kids Research Institute Australia, said it was a “completely exaggerated reading of science.”
“There is categorically no evidence in humans that taking paracetamol during pregnancy is causal of the offspring developing autism,” he said.
“Over the course of my 25-year career, I have seen this time and time again in the area of autism, where autism is weaponised as a part of a culture war.
“Every bit of time, energy, attention and effort that we spend rebutting science that is not proven is time, attention, energy and space taken away from dealing with the things that truly matter to kids and families.”
Disability advocate Clare Gibellini said it would take a lot of work to undo the harm caused by this announcement. (ABC News: Lucas Hill)
Independent disability advocate Clare Gibellini who lives with autism said she was feeling “pretty angry” about the announcement.
“It feels like we’re being scapegoated and it feels like all of the efforts that we as a community have made towards being accepted in our own right is being pushed back again by dangerous rhetoric,” she said.
She said the announcement felt “very gendered” arguing that historically women had been blamed for their children having autism.
“That’s so damaging and as a mum of neurodivergent kids, I also feel like there’s a bit of weaponisation in that argument as well,” she said.
Is paracetamol safe during pregnancy?
The short answer is yes.
In Australia, paracetamol is considered a category A medication during pregnancy, which means it’s been taken by a large number of pregnant women without any proven increase in any direct or indirect harmful effects on their babies.
Like all medications, the official advice is for pregnant women to consult their doctor before taking paracetamol and the current recommendation is to take the lowest effective dose of paracetamol for the shortest amount of time.
But Dr Broom said given it’s a safe, over-the-counter medication women can use their own judgement if treating mild symptoms.
“Women need to be reassured that if they have a headache or they are needing some simple analgesia, they can make that choice themselves. It’s available, and they [often] have it at home and we shouldn’t be gatekeeping their ability to control simple pain and fever,” Dr Broom said.
Experts say women must not avoid taking paracetamol because of the US president’s comments. (Adobe Stock: fizkes)
Paracetamol is also the only over-the-counter option for pregnant women needing to relieve pain as non-steroidal anti-inflammatory drugs, like ibuprofen, can have adverse effects on the foetus, Dr Broom said.
It’s also important to note that fever during pregnancy can be dangerous and has been linked to preterm births or miscarriages.
“So there’s definitely some danger to not taking simple analgesia to control fever and pain,” Dr Broom said.
“I don’t want women to hear this and feel they need to withhold medications until they’re really sick.”
However, if you are needing to take high doses for a prolonged period of time Dr Broom said it was important to seek medical attention.
What will Australia do now?
After reports surfaced yesterday flagging today’s announcement, Health Minister Mark Butler said he had asked for “quick advice,” while urging any pregnant women concerned about the reports to seek medical advice.
In anticipation of the announcement, the national medical regulator — the Therapeutic Goods Administration (TGA) — issued a statement saying paracetamol remained Category A in Australia “meaning that it is considered safe for use in pregnancy.”
Ms Gibellini called for health authorities to speak out against the US administration’s move.
“I really want to see some of our medical experts come out really, really strongly and our Australian government come out really, really strongly in support of the community and in refuting these claims,” she said.
“Whilst we know that this is baseless, much like the ‘autism is caused by vaccines’ argument, it’s going to hang around for a while and it’s going to take a lot of work for us to undo this — if we can.”