This week, questions around the safety of taking paracetamol during pregnancy have been in the headlines, with renewed speculation about whether the common over-the-counter medication increases the risk of autism in children. But according to the science, there is no reliable evidence to support a causal link. Medical experts are warning that the spread of misinformation could do more harm than good by undermining public trust in essential and safe treatments used by pregnant women.
The Therapeutic Goods Administration (TGA) which regulates the safety, effectiveness and quality of medications in Australia has reaffirmed that paracetamol is one of the few medications considered safe during pregnancy and is commonly used to manage pain or bring down high fevers.
“Paracetamol remains Pregnancy Category A in Australia, meaning that it is considered safe for use in pregnancy when used according to directions,” the TGA said in a statement.
Co-director of HMRI’s Mother’s and Babies Research Program, Professor Craig Pennell, who is also Chair of Obstetrics and Gynaecology at the University of Newcastle and a Senior Staff Specialist at the John Hunter Hospital, said unproven claims linking paracetamol use by pregnant women to autism “do not accurately reflect the published evidence and have the potential to cause harm to pregnant women and their babies.”
Professor Pennell pointed to a landmark population study1 published this year in the Journal of the American Medical Association as the most reliable source of evidence to date. The study used a method called sibling control analysis, which accounts for genetics and environmental factors by comparing outcomes among siblings with different exposures to the medication. The research, conducted in Sweden, involved nearly 2.5 million children born between 1995 and 2019.
“When the sibling control method of analyses was not used in this large population-based study, there was a marginal increase in the risks of autism and ADHD associated with paracetamol use in pregnancy. However, when the appropriate statistical methodology (the sibling control approach) was used, there was absolutely no evidence of increased risk of autism, ADHD or intellectual disability. Families should be reassured by the good quality evidence that reports no association and hence no potential causation.”
Despite the lack of evidence for a link with autism, concerns over paracetamol use persist, but Professor Pennell warns that the real danger lies in untreated illness during pregnancy, particularly when it comes to prolonged high fevers.
“High temperatures during pregnancy have the potential to cause adverse pregnancy outcomes. Sustained fever of 39 degrees or greater for at least 24 hours in the first trimester is associated with an increased risk of miscarriage and certain structural malformations including neural tube defects like spina bifida.2”
In such cases, avoiding treatment out of fear can pose far greater risks to both the pregnant woman and her unborn child.
“As with all medication in pregnancy, we recommend taking the lowest doses for the shortest period when possible. If women have persistent high temperatures, taking paracetamol for a day or two is safe and likely to have benefits to the mother and baby. If you have any concerns about any other medication during pregnancy, you should check with your obstetric care provider,” Professor Pennell said.
Dr Laura Roche, a Healthy Minds researcher at HMRI and Senior Lecturer at the University of Newcastle, said understanding autism is critical when assessing public claims about its causes.
“Autism is a neurodevelopmental difference that persists across the lifespan,” said Dr Roche. “Autistic people may communicate, behave or process sensory information in different ways, and each person will have unique strengths and challenges. No two autistic people are the same.”
“We do not currently know exactly what causes autism, but research shows that both genetic and environmental factors are involved3. Autism is one of the most heritable neurodevelopmental conditions4 5. Its causes are complex and not linked to a single exposure or behaviour.”
While research into the causes of autism is ongoing, most experts agree it results from a complex combination of genetic and environmental factors6. No single medication or exposure has ever been found to cause autism and attempts to link widely used drugs like paracetamol are not supported by well-controlled studies.
“The problem with unfounded, sensationalised statements is that they oversimplify complex issues and can cause real harm. Telling mothers that taking paracetamol will cause autism, without evidence, places blame on pregnant women and adds to the stigma and stress they already face7,” said Dr Roche.
“When we overly simplify complex ideas about autism, especially in pregnancy, we risk spreading misinformation that can harm families”
“These claims can reinforce the harmful idea that autism is a problem to be fixed, rather than a neurodiversity to be understood and supported8. What can be fixed is how society responds to autistic people’s different ways of thinking and being, and how we effectively support every autistic person to feel valued, respected, and safe9.”
For families navigating pregnancy, this kind of misinformation can be distressing. Health experts are urging pregnant women not to make medical decisions based on headlines or social media posts. They advise speaking to a qualified healthcare provider when seeking advice about medications or health risks during pregnancy.
The overwhelming consensus from good quality research is that paracetamol is safe and effective to use in pregnancy when used appropriately.
