The Malta Independent 13 August 2026, Thursday
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No direct causation between paracetamol and autism in foetuses, Maltese Autism Advisory Council says

Tuesday, 23 September 2025, 17:50 Last update: about 12 months ago

The Maltese Autism Advisory Council has urged caution against public announcements by the United States Food and Drug Administration (FDA). Amongst the claims made by the FDA is that paracetamol - commonly sold as Panadol in Malta - "is linked to a greater risk of causing autism in the foetus, when taken by pregnant persons."

The Maltese Autism Advisory Council has stated that while the FDA made reference to different studies in its announcements, "there is nothing in said studies that currently proves direct causation."

"The fact that some persons took paracetamol in pregnancy, and their children were eventually diagnosed with autism, does not mean that there is a direct link, unless the data shows this regularly and consistently," the Autism Advisory Council said.

On this point, the Autism Advisory Council referenced a study - the Harvard/Mount Sinai review - that looked into 46 such studies to analyse whether or not such data showed a regular and consistent direct link. It noted that "the results coming out of this review were so inconsistent that a meta-analysis [to check for a direct link] was unable to be performed." Only 27 out of 46 studies showed some kind of association - far from a direct link - to the extent that the review's lead author compared this false hypothesis to the association between ice-cream sales and crime, as both phenomena increase in summer, though such trends offer zero real connection to one another.

In its statement, the Autism Advisory Council also noted that the European Medicines Agency's (EMA) earlier official guidance on taking paracetamol during pregnancy remained unchanged.

"Paracetamol remains an important option to treat pain or fever in pregnant women. Our advice is based on a rigorous assessment of the available scientific data and we have found no evidence that taking paracetamol during pregnancy causes autism in children," said the EMA's Chief Medical Officer Steffen Thirstrup.

The Autism Advisory Council reminded that "in good academic practice," correlation does not imply causation.

On this point, it concluded that unless hard evidence backed by hard science is at hand, "it is both unprofessional and unfair to present such theories as fact to expectant mothers, while racking others with guilt, leading them to believe that their autistic child's support needs are the direct result of having taken a common painkiller during pregnancy."

In this statement, the Autism Advisory Council took the opportunity to speak against prescribing children with supplements of leucovorin to minimally verbal children. It observed that leucovorin, in Malta, is currently only given to chemotherapy patients.

"Although some work has shown a possible association to improving speech in minimally verbal children, the results are still early and anecdotal," the Maltese Autism Advisory Council said, "It would be irresponsible to prescribe this substance to children before large-scale, properly managed clinical trials are conducted, to verify the appropriateness of regularly giving leucovorin to young children."

The Autism Advisory Council ended its statement by declaring that while it is not opposed to further research on autism in line with Malta's National Autism Strategy (2021-2030), it has a duty to autistic people and their families to ensure that "only reliable courses of action, based on good science," are promoted. It added that such should be offered in parallel with continued efforts to improve quality of life through ever-evolving social services and support.


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