Paracetamol use in pregnancy is safe, no link to autism, ADHD, says Lancet: Why this is a gold-standard study
Researchers say earlier studies were biased and failed to account for genetics and maternal illness
Across the sibling-comparison studies, data included 262,852 children assessed for autism, 335,255 for ADHD and 406,681 for intellectual disability.
Taking paracetamol during pregnancy does not increase the risk of autism, attention-deficit hyperactivity disorder (ADHD) or intellectual disability among children, according to a latest study in The Lancet. This clears the confusion that had arisen from US President Donald Trump’s statement in September last year, suggesting paracetamol use during pregnancy is linked to autism in children.
This is the most rigorous analysis of evidence till date, based on 43 studies, and was led by researchers from City St George’s, University of London. It has been published in ‘The Lancet Obstetrics, Gynaecology and Women’s Health.’
What is the safety profile of paracetamol?
Paracetamol or acetaminophen is the most commonly used analgesic and antipyretic during pregnancy, recommended globally as a first-line option for pain relief and fever reduction. Its safety profile is generally more favourable than that of non-steroidal anti-inflammatory drugs and opioids, making it the preferred choice in obstetric care. The claims were based on earlier studies that reported small associations between paracetamol in pregnancy and increased risks of autism. However, these were often based on studies prone to bias, insufficient data and not exploring comparisons between siblings to account for family history.
A sibling comparison study
At a virtual interaction with reporters, Asma Khalil, professor of obstetrics and maternal foetal medicine at City St George’s, University of London, explained that the team compared pregnancies where the mother had taken paracetamol to pregnancies where they had not. They pooled the results of sibling comparison studies that compared siblings born to the same mother, where one pregnancy involved paracetamol exposure and another did not. This design helps control for shared genetics, family environment and long-term parental characteristics that traditional studies cannot fully account for.
Across the sibling-comparison studies, data included 262,852 children assessed for autism, 335,255 for ADHD and 406,681 for intellectual disability.
When compared to pregnancies with no exposure to paracetamol, it was confirmed that taking paracetamol in pregnancy was not linked to childhood autism, ADHD or intellectual disability.
“Our findings suggest that previously reported links are likely to be explained by genetic predisposition or other maternal factors such as fever or underlying pain, rather than a direct effect of the paracetamol itself,” Prof Khalil said, adding, “The message is clear – paracetamol remains a safe option during pregnancy when taken as guided. This is important as paracetamol is the first-line medication we recommend for pregnant women in pain or with a fever, and so they should feel reassured that they still have a safe option to relieve them of their symptoms.” Avoiding paracetamol may unintentionally increase harm, particularly if the fever is left untreated, the researchers feel.
Gold standard findings
She further explained that all studies were assessed with the Quality In Prognosis Studies (QUIPS) tool that evaluates numerous factors in the way the research has been conducted to determine the risk of bias. Overall, the findings of the study support the recommendations made by major medical organisations worldwide.
Researchers hope that this gold-standard review will put an end to any scepticism on using paracetamol during pregnancy. Avoiding paracetamol for significant pain or fever can expose both mother and baby to known risks.
Dr Sanjay Gupte, former president of the Federation of Obstetrics and Gynaecologists’ Society of India, reiterated that the study had cleared the confusion once and for all. “When the paracetamol controversy blew up in social media, some pregnant patients of mine, who had taken paracetamol to sort out pain and fever, had become extremely worried. I repeat, taken in the proper dose, there is no cause for concern,” he says.
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