The agency that regulates medicines in Australia says paracetamol is considered safe for use in pregnancy, despite Donald Trump saying it increases the risk of autism in babies.
Mr Trump said that he believed pregnant women should "strongly" limit the use of paracetamol, also known as acetaminophen, unless they had an "extremely high fever" that they could not "tough out".
"Pregnant women should talk to their doctors," Mr Trump said.
"Ideally, you don't take it at all."
The Food and Drug Administration (FDA), which regulates medicines in the US, will issue a physician's notice about the potential risks of taking paracetamol during pregnancy and begin the process of initiating a safety label change on the medication, Health and Human Services Secretary Robert F Kennedy Jr said.
But the Australian regulator, the Therapeutic Goods Administration (TGA), along with the Australian Medical Association (AMA), the Royal Australian and New Zealand College of Obstetricians and Gynecologists and their American counterpart, have all reaffirmed the safety and benefits of paracetamol in pregnancy.
"Paracetamol remains Pregnancy Category A in Australia, meaning that it is considered safe for use in pregnancy," the TGA said in a statement.
"The TGA has no current active safety investigations for paracetamol and autism, or paracetamol and neurodevelopmental disorders more broadly."
AMA president Dr Danielle McMullen told ABC News Breakfast that regulators considered paracetamol safe to use during pregnancy.
"Of course, like all medications, we try to use as little as possible when pregnant, but certainly for pain and fever in pregnancy, the advice here in Australia still is that paracetamol is still a reasonable and safe option for pregnant women to use," she said.
Dr Norman Swan, host of the ABC's Health Report, said pregnant women were taking paracetamol for a reason.
"Fever in pregnancy is not good for the unborn child and you want to prevent fever, hence influenza immunisation, hence COVID immunisation," he said.
"You want to minimise the chances a woman will get infected with a virus.
"If you do get a fever, paracetamol is what will get rid of it."
He added, "you shouldn't be taking any drug in pregnancy unless you need it".
"But, if you need it, take it: you need to be more worried about the fever than the paracetamol," he said.
Association does not mean causation
Andrew Whitehouse, professor of autism research at the Kids Research Institute Australia and a director of Autism Awareness Australia, said there had been several studies exploring whether taking acetaminophen (also called paracetamol) during pregnancy could increase the likelihood of the offspring of the pregnancy being diagnosed with autism.
"Some studies have reported small associations, but these findings are not consistent and do not prove that acetaminophen directly causes autism," he said in a statement.
"Autism is a complex condition influenced by many genetic and environmental factors.
"Any small associations in this area need to be weighed against the risk of untreated high fever in pregnancy for the woman and the developing baby."
A study in Sweden that analysed data from 2.48 million births found that when researchers compared siblings (a method to control for genetic and environmental factors), any apparent links between acetaminophen and autism disappeared.
Dr Hannah Kirk, a National Health and Medical Research Council fellow at Monash University, said suggestions that paracetamol (commonly sold in the US as Tylenol) use during pregnancy could increase the risk of autism had, understandably, raised concern among expectant parents.
"Autism is a neurodevelopmental condition with no known single cause, however, research shows that genetics play a large role, with hundreds of genes being linked to autism," she said.
"No study has shown that acetaminophen, the main ingredient in Tylenol, causes autism.
"Some studies have reported an association between acetaminophen use and autism, while others have not.
"Importantly, association does not mean causation."
Professor Scott White from the Royal Australian and New Zealand College of Obstetricians and Gynaecologists described the stance from the White House as "surprising", in terms of the science.
"Having a fever early in pregnancy can be associated with all sorts of adverse pregnancy outcomes other than just autism," Professor White said.
"I would quite confidently use paracetamol in pregnancy and statements like 'pregnant women should just tough it out, if they have a fever,' contribute to what we see about limiting use of medications that are clearly safe for pregnant women."
