The Therapeutic Goods Administration (TGA) has confirmed that paracetamol (Tylenol/Acetaminophen) is safe to use during pregnancy, rejecting controversial claims made by the US Donald Trump administration regarding an increased risk to the development of autism in children.
Joining numerous other global medicines regulators, leading clinicians and scientists worldwide, the TGA said the views were unfounded.
“Robust scientific evidence shows no causal link between the use of paracetamol in pregnancy and autism or ADHD, with several large and reliable studies directly contradicting these claims,” it said in a statement.
“Paracetamol remains the recommended treatment option for pain or fever in pregnant women when used as directed. Importantly, untreated fever and pain can pose risks to the unborn baby, highlighting the importance of managing these symptoms with the recommended treatment.”
The TGA said pregnant women should speak to healthcare professions if they have any questions about taking any medication while pregnant.
“Paracetamol remains pregnancy category A in Australia, meaning that it is considered safe for use in pregnancy when used according to directions in TGA-approved Product Information (PI) and Consumer Medicines Information (CMI) documents.
“This means that a medicine has been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other harmful effects on the fetus having been observed. As with the use of any medicine during pregnancy, people who are pregnant should seek medical advice tailored to their specific circumstances before taking paracetamol.”
The TGA noted that while there are published articles suggesting an association between maternal paracetamol use and childhood autism, they had “methodological limitations”. More recent and robust studies have refuted these claims, supporting the weight of other scientific evidence that does not support a causal link between paracetamol and autism or ADHD, they said.
