Paracetamol in pregnancy not linked to autism or ADHD, ‘rigorous’ UK-led review finds

Taking paracetamol during pregnancy does not increase the risk of autism, ADHD, or intellectual disability among children, a large review led by UK researchers has concluded.

The analysis of 43 studies was done after claims made by US President Donald Trump in September of a suggested link.

Announcing that the US Food and Drug Administration (FDA) had ‘initiated the process for a label change’ for products containing paracetamol (referred to in the US as acetaminophen), Mr Trump had said the painkiller was ‘no good’ for pregnant women.

The FDA said the label change was being done ‘to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children’.

At the time the UK medicines regulator said it would not review its guidance with current evidence supporting safe use of paracetamol in pregnancy and advice that had been consistent for many years.

In response, a team of researchers carried out ‘the most rigorous analysis’ to date, which found no ‘clinically important’ association based on current evidence.

Some studies in the past had reported small associations between paracetamol in pregnancy and increased risks of autism but these were prone to biases, limited by the type of data collected and had not looked at comparisons between siblings to account for family history.

The latest analysis published in The Lancet Obstetrics, Gynaecology and Women’s Health looked specifically at studies that had compared pregnancies where the mother had taken paracetamol to pregnancies where they had not taken the drug.

Focusing on sibling comparison studies helps control for shared genetics, family environment and long-term parental characteristics, they wrote.

Overall, they compared 262,852 children assessed for autism, 335,255 for ADHD and 406,681 for intellectual disability and found no link.

The researchers said the findings support the recommendations made by major medical organisations worldwide and will hopefully put an end to any scepticism on using paracetamol during pregnancy, noting that untreated maternal fever was a known risk.

Study leader Professor Asma Khalil, professor of obstetrics and maternal fetal medicine at City St George’s, University of London said the 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.

She said: ‘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.’

Professor Grainne McAlonan, professor of translational neuroscience at King’s College London said expectant mothers do not need the stress of questioning whether medicine most commonly used for a headache could have far reaching effects on their child’s health. 

She said: ‘This thorough and clear study approached the question by conducting both a substantial systematic review of the literature and a meta-analysis of eligible studies.

‘While the impact of last year’s announcement has been extensive, I hope the findings of this study bring the matter to a close.’