Major review confirms paracetamol safety for expecting mothers, refutes autism link

A comprehensive scientific review has confirmed there is no convincing evidence linking paracetamol use during pregnancy to autism or ADHD in children, validating the common-sense approach already taken by many in Malta and providing clear reassurance to expectant mothers and their doctors.

The findings, published in the British Medical Journal this week, directly counter baseless claims made recently by former US President Donald Trump, which had sparked a wave of international concern. The review concludes that any apparent link in previous studies was likely due to underlying family genetics and other factors, not the painkiller itself.

This scientific consensus reinforces the position reported by BusinessNow.mt last month, which found the Maltese public largely dismissing the controversy, with local pharmacies reporting “business as usual.”

The new research is an “umbrella review,” analysing nine previous systematic reviews that themselves encompassed 40 individual observational studies. While many of these earlier studies reported a possible association, the new analysis found their quality ranged from “low to critically low” and failed to account for crucial confounding factors.

The most compelling evidence came from a large 2023 Swedish study of 2.4 million children. It found that when researchers compared siblings – where one was exposed to paracetamol in the womb and the other was not – the slight increase in neurodevelopmental diagnoses completely disappeared.

“If there’s a family history of autism and ADHD, either in the parents or the siblings, then it is likely that that is the reason a child is diagnosed rather than something the mother took in pregnancy,” said Prof Shakila Thangaratinam, a consultant obstetrician and senior author of the review at the University of Liverpool.

She added a crucial message for mothers: “They might have a child that is autistic with ADHD and we really don’t want them to think it’s because of something they did in pregnancy. That’s a terrible feeling for a mother to have. There isn’t anything in the current evidence that suggests mothers taking paracetamol is actually causing autism and ADHD.”

This definitive review confirms the initial reaction in Malta. Last month, a spot-check by this newsroom found that pharmacists across the islands had fielded almost no questions from concerned customers, with one dismissing Trump’s comments as “nonsense” and noting that “people have used their common sense.”

While some expectant mothers had understandably contacted their family doctors with questions, the public sentiment largely leaned towards scepticism of the unsupported claims. This latest research affirms that their trust in the established safety of paracetamol was well-placed.

The World Health Organization (WHO) has also pushed back against the contested claims, stating that “extensive research… has found no consistent association.” The global health body recommends that “all women continue to follow advice of their doctors or health workers.”

For pregnant women, this advice remains unchanged. Paracetamol is the recommended painkiller for managing fever and pain during pregnancy, as alternatives like ibuprofen are not recommended.

“Women should know that the existing evidence does not really support a link between paracetamol and autism and ADHD,” Prof Thangaratinam stated. “If pregnant women need to take paracetamol for fever or pain then we would say please do, particularly because high fever in pregnancy could be dangerous to the unborn baby.”

The publication of the review was fast-tracked to provide reliable information to the public and healthcare professionals, effectively closing the door on a debate fuelled by speculation rather than robust science. For Maltese mothers and their families, it is a welcome confirmation that following medical guidance is the safest path forward.