U.S. health officials have announced a possible link between paracetamol and autism. Australia’s TGA has rejected the claims. AAP Image/Jono Searle
Australia’s medicines regulator has said paracetamol (also known as acetaminophen) remains safe for pregnant women.
The move came after Health Minister Mark Butler asked the Therapeutic Goods Administration (TGA) for urgent advice, following comments by U.S. President Donald Trump linking the drug to autism.
The TGA said paracetamol is still classified as a Category A medicine—meaning it is widely used and considered safe during pregnancy.
Officials said there are no active investigations into links with autism or other neurodevelopmental disorders.
“The use of medications in pregnancy is subject to clinical, scientific, and toxicological evaluation at the time of registration,” the TGA said in a statement to The Epoch Times.
It added that all medicines undergo strict post-market surveillance, including analysis of adverse event reports, reviews of published research, and close coordination with international regulators.
The TGA said its monitoring system remains robust, reviewing consumer reports, clinician input, and global data before making decisions. At present, there is no evidence requiring any change to paracetamol’s pregnancy safety rating.
It encouraged Australians to speak with healthcare professionals for tailored advice.
“Paracetamol remains safe for use in pregnancy when taken as directed,” the regulator said.
No Evidence of Harm: AMA
Australian Medical Association President Danielle McMullen also dismissed Trump’s claim.
“There are no studies showing that paracetamol use in pregnancy causes autism,” she told ABC’s RN Breakfast.
“There have been some studies showing what we call an association between paracetamol use and autism in children, but there’s also been really large studies showing that there’s no association. And it’s important to remember that association doesn’t mean cause.”
She said autism is far more likely to be linked with genetic factors, and that pregnant women should not be alarmed.
“The advice here in Australia still is that paracetamol is a reasonable option and safe option for pregnant women to use,” McMullen said.
