UK medicines regulator will not review guidance on paracetamol in pregnancy

The Medicines and Healthcare Products Regulatory Agency (MHRA) will not review its guidance on paracetamol in pregnancy, the Government has said – in response to high-profile claims regarding a link to autism made by the President of the USA.

The UK’s Department of Health and Social Care stressed in an update that ‘current evidence supports the safe use of paracetamol during pregnancy when used as directed’, and it noted this ‘advice has been consistent for many years’.

Earlier this week, the US Food and Drug Administration (FDA) announced that it had ‘initiated the process for a label change’ for products containing paracetamol (referred to in the US as acetaminophen).

It said this was ‘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’.

It referred to ‘a considerable body of evidence about potential risks associated with acetaminophen’; however notably did not advice completely against the use of paracetamol in pregnancy.

FDA commissioner Marty Makary stressed instead that ‘the choice still belongs with parents’.

‘The precautionary principle may lead many to avoid using acetaminophen during pregnancy, especially since most low-grade fevers don’t require treatment,’ he said.

‘It remains reasonable, however, for pregnant women to use acetaminophen in certain scenarios.’

As evidence, the FDA linked to studies which had found ‘correlation’ between the the use of paracetamol in pregnancy and autism and ADHD, including the Nurses’ Health Study II and the Boston Birth Cohort.

However, it went on to stress: ‘It is important to note that while an association between acetaminophen and neurological conditions has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature.’

In a separate note directed at doctors, the FDA further downgraded the warning, saying: ‘In the spirit of patient safety and prudent medicine, clinicians should consider minimising the use of acetaminophen [paracetamol] during pregnancy for routine low-grade fevers.’

‘This consideration should also be balanced with the fact that acetaminophen is the safest over-the-counter alternative in pregnancy among all analgesics and antipyretics; aspirin and ibuprofen have well-documented adverse impacts on the foetus,’ it added.

In the UK, the DHSC said: ‘The MHRA carefully monitors new evidence on the safety of medicines and takes action when evidence shows a potential risk to patients.

‘In the case of paracetamol use in pregnancy, recent studies, including the one published in August, have not established a direct relationship between paracetamol use during pregnancy and an increased risk of autism.’

It also pointed to a major study conducted in Sweden in 2024, involving 2.4 million children, which ‘found no evidence that paracetamol causes autism in pregnancy’.

The DHSC added that the ‘MHRA carefully monitors new evidence on the safety of medicines and takes regulatory action when of evidence shows a potential risk to patients, which exceeds the potential benefits’.

Dr Monique Botha, associate professor in Social and Developmental Psychology at Durham University, said: ‘There are many studies which refute a link, but the most important was a Swedish study of 2.4 million births (1995–2019) published in 2024 which used actual sibling data and found no relationship between exposure to paracetamol in utero and subsequent autism, ADHD or intellectual disability.

‘This suggests no causal effect of paracetamol in autism. This is further strengthened by there being an absence of a dose dependent relationship. There is no robust evidence or convincing studies to suggest there is any causal relationship and any conclusions being drawn to the contrary are often motivated, under-evidenced, and unsupported by the most robust methods to answering this question. I am exceptionally confident in saying that no relationship exists.

‘Similarly, pain relief for pregnant women is woefully lacking and paracetamol is a a much safer pain relief option during pregnancy than basically any other alternative and we need to take pain seriously for women including whilst pregnant. The fear mongering will prevent women from accessing the appropriate care during pregnancy. Further, it risks stigmatising families who have autistic children as having brought it on themselves and reinvigorates the long pattern of maternal shame and blame as we’ve seen re-emerge repeatedly over the last 70 years where we try to pay the fault of autism at the mother’s door one way or another.’