The safety of paracetamol during pregnancy has been thrust into the spotlight after claims by the US Department suggested a possible link between the common pain reliever and autism. Australian experts, however, are pushing back, stressing that the evidence overwhelmingly shows paracetamol (when taken as directed) nremains one of the safest medications for pregnant women.
Paracetamol does not cause autism contrary to the statements made by the US Department. Autism is a complex condition influenced by many genetic and environmental factors. For example, there are “shared genes” that have been identified in those with attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD). We also know that almost half of those with ASD, will have ADHD. The reverse is true as well, that some people with ADHD have autism also.
The collective voice of expert Australian researchers is that there are no scientific studies that have proven a causal relationship between paracetamol in pregnancy and autism. Announcing such claims of a possible link, has created unnecessary fear and anxiety in the community. We all want to find answers to the cause of disease and especially the diseases that affect children, but making alarmist, inaccurate statements, risks swaying the focus of funding for research.
The most prominent recent study that refutes the claim that there is a link between autism and paracetamol, was conducted in Sweden and published in 2024. This looked at the records of nearly 2.5 million births that occurred between 1995 and 2019. In this study, the researchers compared siblings for genetic and environmental factors. The findings were that there was no increased risk of autism when their mothers took paracetamol while pregnant. The results of the United States study have to be considered as with any study, and this is not the first study that has made such claims. However, in light of this large body of evidence from the Swedish study, the risks to the unborn baby when exposed to paracetamol in utero, are negligible when given in small doses for a short time.
There is no plan by the Therapeutic Goods Authority (TGA) here in Australia to further investigate paracetamol (Panadol, Panamax), which is also known as acetaminophen or Tylenol. Paracetamol remains a category A drug for level of safety in pregnancy, which is the safest classification of any drug. This means is that over many years of paracetamol being available, there are no harms to the unborn baby when taken whilst pregnant.
The collective voice of Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RAZCOG), the Royal Australian College of General Practitioners (RACGP), Australian Medical Association (AMA) along with the American College of Obstetricians and Gynaecologists, have all responded to the US Government’s comments, stating that paracetamol is safe when taken in recommended doses during pregnancy. Ultimately, it is the pregnant women who will need to make their own minds up on this matter and they will need to weigh the risks of not treating their symptoms against the potential harms they fear might be linked to their treatment.
For pregnant women in the community who are worried about what to do when they have pain or fever, they should see their doctor to determine the cause of their pain or temperature and have the appropriate investigations. They should not ignore their symptoms. It is safe to take Panadol at the recommended dose for symptoms in pregnancy. Untreated high fever in the early part of the first trimester, can cause miscarriage, neural tube defects such as spina bifida, cleft palate, heart malformations, and abdominal wall defects. In later pregnancy, untreated high fever can cause premature onset of labour and has been associated with stillbirth. The Royal Women’s Hospital which is a beacon for women’s health and maternal and baby health considers taking paracetamol safe in pregnancy when taken in the lowest possible dose for the shortest possible time.
Sources: Bauer, A.Z., Swan, S.H., Kriebel, D. et al. Paracetamol use during pregnancy, a call for precautionary action. Nat Rev Endocrinol 17, 757–766 (2021). https://doi.org/10.1038/s41574-021-00553-7 Ahlqvist VH, Sjöqvist H, Dalman C, et al. Acetaminophen Use During Pregnancy and Children’s Risk of Autism, ADHD, and Intellectual Disability. JAMA. 2024;331(14):1205–1214. doi:10.1001/jama.2024.3172
*Associate Professor Magdalena Simonis is a GP, senior academic at the University of Melbourne’s Department of General Practice, and Fellow of the Royal Australian College of General Practitioners. She is widely recognised for her work in women’s health, primary care, and health policy, and frequently contributes expert commentary to public debates on medical safety and community health.
