Paracetamol remains the safest option for pain and fever in pregnancy. Misinformation risks pushing women toward dangerous alternatives.
Paracetamol remains safe to use during pregnancy, with Australian experts countering US president Donald Trump’s controversial claim that it may be linked to autism in babies.
Doctors are bracing for an inundation from concerned patients following the press conference held by Mr Trump and his Health and Human Services secretary Robert F Kennedy Jr.
Mr Kennedy said the US Food and Drug Administration planned to issue a physician advisory on potential risks of using the medication during pregnancy and initiated a safety label change on the medication.
Mr Trump said he believed pregnant women should “strongly” limit the use of paracetamol.
“Pregnant women should talk to their doctors,” Mr Trump said. “Ideally, you don’t take it at all.”
Australia’s FDA counterpart, the Therapeutic Goods Administration (TGA), has joined a groundswell of experts, peak bodies and other groups to refute the president’s claim.
These include the Australian Medical Association, and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists.
“Paracetamol remains Pregnancy Category A in Australia, meaning that it is considered safe for use in pregnancy,” the TGA said in a statement.
“The TGA has no current active safety investigations for paracetamol and autism, or paracetamol and neurodevelopmental disorders more broadly.”
AMA president Dr Danielle McMullen described the comments as “garbage” but said there were cohorts of the community who would be really worried by the story that has dominated the news this week.
She said GPs would be likely to field questions from patients concerned about the use of paracetamol in pregnancy.
“We can confidently say that there is no study that shows paracetamol use during pregnancy causes autism. That is true,” she told The Medical Republic, Health Services Daily’s sister publication.
“We don’t know the cause of autism. The current weight of evidence would say it has predominantly genetic factors, that there’s over 100 genes implicated, and some overlay of environmental causes, but that that plays out differently in different families.”
Dr McMullen said there had been research showing some association between the drug and autism, but there were also large studies that showed no association and nothing that shows causation.
“There is no change in the medical advice here [in Australia]. It’s still a category A medication that should be used to treat symptoms in pregnancy,” she said.
“Obviously women are already trying to reduce all medication use in pregnancy. People aren’t just taking a medication for the sake of it, but pain and fever can cause damage to pregnancies, particularly high fever in early pregnancy.”
Dr McMullen said she was deeply concerned that some women might turn to alternative pain and fever medications like ibuprofen and other NSAIDs that are known to be unsafe to take during pregnancy.
“I am also concerned that people will avoid paracetamol and take something else instead,” she told HSD.
“We know that ibuprofen and other NSAIDs can have harmful impacts on pregnancies, so we’ve spent generations telling people not to take them in pregnancy.
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“So I think advice for GPs to use this as a reminder that paracetamol remains our safest option in pregnancy. And … intermittent dosing is unlikely to cause harm. If people are concerned about those who need to be on more long-term paracetamol during their pregnancy, and we don’t have any reason to think it’s not safe, GPs can always seek specialist advice.”
Professor David Trembath, head of Autism Research and senior principal research fellow at CliniKids, The Kids Research Institute Australia, told HSD he expected to see a lot of concern from parents, parents-to-be, and people on the autism spectrum.
“Parents are already under so much pressure. Mums-to-be are put under so much pressure, and this just adds to that mix,” he said.
“I’m hoping that they will be able to see this for what it is, to double down on what we know works and is really important, and to continue to follow the really good science-based medical advice that’s available here in Australia.”
He said that as a researcher who worked closely with children on the spectrum, he was frustrated to see resources, time and energy being directed towards something that had been plainly disproven.
“Right now, the key priority is to improve access to high quality personalised supports that can make a genuine positive difference in the lives of autistic children, young people, adults and their families,” he said.
“And every time we spend $1 of research funding on trying to answer a question that really has no basis, it takes that money away from research that could be doing a lot more good in the community.”
On a personal level he said he was deeply aware of the backwards steps being taken and the impact on autistic individuals and their families.
“It upsets me that parents are having to be exposed to this really unnecessary commentary and questions and concerns,” Professor Trembath said.
“There’s enough on parents’ plates, and now over the coming weeks, they will be thinking about this and having to answer questions about it from people around them. The scrutiny parents of autistic children are put under when it comes to raising their kids is horrendous.
“That’s probably the thing upsets me the most. It’s unnecessary and it’s wrong.”
He said there was no strong evidence to suggest a link between autism and paracetamol use by a woman during pregnancy.
“It feels like we’re going over old ground, to be honest, these sort of questions around paracetamol or other things related to diet or environment and so forth,” he said.
“When it comes to the actual question, is there a link between paracetamol and autism, there is some evidence, but it is a bit like finding a grain of sand on the ground and calling it a beach.
“In some studies we see a small association, but it’s tiny. We’re talking about going from a 1% likelihood of a child developing autism or being diagnosed with autism, to about 1.2%. It’s really, really small.
“Yes there is some research that indicates a small association, but it comes nowhere close to justifying the claims being made.”
In relation to Mr Trump’s claims that the drug leucovorin could treat autism, Professor Trembath urged caution.
Leucovorin is chemically related to vitamin B9, or folate. It is currently used to help patients with side effects from chemotherapy. Leucovorin calcium is approved for use in Australia and indicated to diminish the toxicity and counteract the action of folic acid antagonists such as methotrexate in cytotoxic therapy and overdose in adults and children.
“My understanding is that the hypothesis is that autism is caused by low levels of folic acid or folate, and that this drug could somehow change those levels and therefore lead to better outcomes,” he said.
“I’ve seen some preliminary research and suggestions of some small positive effects, but it’s far from a clear and large effect, if there is one. We need to tread cautiously with this.
“As a science and research community, whenever there’s a suggestion that has any degree of plausibility, there’s a proper process to go through and to design the well-controlled studies that take into account all of the possible explanations and considerations to come up with really clear, proper advice.
“There may be some further research on this, but the priority must continue to be on developing new and better ways to support autistic people and their families in day-to-day life, and that answers the questions that are most important to them.
“If parents have any questions, they should talk to their doctor.”
On the subject of autism and vaccine links, raised by Mr Trump and also repeatedly by Mr Kennedy Jr, Professor Trembath said it felt like history repeating itself.
“We’re going over the same old ground with this one too – there is such a clear and consistent picture when it comes to the evidence around the safety of vaccines for kids and the lack of an association between vaccines and autism,” he told TMR.
“We are talking about a couple of decades of research involving hundreds of thousands of kids and families and being followed and looking at, looking for any signal, for a potential association, and it just keeps coming [up] with nothing.
“It really is a very clear picture around vaccines and safety. And it’s unfortunate that some people are taking time and using resources to keep looking at the same question with the thought that they might find a different answer.”
Sydney epidemiologist, writer and senior research fellow at the University of Wollongong Dr Gideon Meyerowitz-Katz was well ahead of the debate when he penned a piece on the paracetamol/autism issue on his Substack on 9 September.
“Fortunately for pregnant women everywhere, it’s very unlikely to be true,” he wrote.
“The best evidence we’ve got shows that acetaminophen is probably fine to use in pregnancy.”
Dr Meyerowitz-Katz referenced a study published in BMC Environmental Health that looked at the evidence on paracetamol (acetaminophen in the US) use and neurodevelopmental disorders from seven other studies.
“Of these studies, the findings were hardly conclusive. Study 1 did not find a link between autism and acetaminophen. Study 2 did, but it was by far the most useless paper of the bunch,” he wrote.
“Study 3 found some association with autism and acetaminophen in one analysis, but not another. Study 4 only found an association for one specific subtype of autism, but not autism as a general diagnosis. Study 5 found an association between acetaminophen in pregnancy and autism in for baby boys, but not girls nor for the entire sample when boys and girls were combined.
“Studies 6 and 7 found consistent associations between the drug in pregnancy and autism diagnosed in children.
“This is hardly strong evidence. It’s not even a consistent association. The single biggest paper ever written on the question of whether acetaminophen causes autism is the Swedish study listed there, Study 3.
“Looking at over 2.5 million total mother/child pairs, they found in one analysis that there was a very modest association between reported maternal intake of acetaminophen.”
He noted that “none of these studies are very strong”, and that “the data thus far, especially the highest-quality studies out there, does not show that acetaminophen causes autism”.
“It doesn’t even show a consistent association,” Dr Meyerowitz-Katz wrote.
“It’s quite likely that the associations seen in some studies are spurious statistical noise rather than a true correlation between the drug and learning difficulties.
“If you’re pregnant, or know someone who is, I think that the current guidelines for acetaminophen/paracetamol use are very reasonable.
“Use it sparingly, for the shortest time-frame possible. It is one of the few drugs that we have quite good evidence for in pregnancy, and the data is in my opinion quite reassuring.
“There is certainly no evidence whatsoever that the upsurge in autism diagnoses has any relationship to acetaminophen use.”
The supplier of Panadol in Australia, Consumer Healthcare Products Australia, also weighed into the debate, issuing a statement that said, “paracetamol is one of the most widely used analgesics, with a long-standing safety record supported by decades of research and everyday use”.
“Globally, paracetamol remains the only option for pain and fever considered appropriate for use during pregnancy, when taken as directed and under the guidance of a healthcare professional,” it said.
“In Australia, the Therapeutic Goods Administration (TGA) continues to classify paracetamol as a Pregnancy Category A medicine. This is in line with current scientific evidence [which] does not show a causal link between paracetamol use and adverse neurodevelopmental outcomes, including autism.”