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US President Donald Trump announced Monday that the US Food and Drug Administration will be notifying physicians that the use of acetaminophen, known as paracetemol in Australia, during pregnancy “can be associated with a very increased risk of autism.”
“They are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary,” he said.
Tylenol is available for sale in Australia, and there are currently no active safety investigations into its use during pregnancy.
Australia’s Therapeutic Goods Administration (TGA), which regulates the safety of medicines, told 9News.com.au that “people are encouraged to consult their treating healthcare professionals for clinical advice tailored to their specific circumstances”.
“Paracetamol remains Pregnancy Category A in Australia, meaning that it is considered safe for use in pregnancy,” a spokesperson for the TGA said in a statement.
”When safety signals are identified for a medicine, they are subject to detailed clinical and scientific investigation to confirm that a safety issue exists, and if confirmed, what regulatory actions are most appropriate to mitigate the risk.
“The TGA has no current active safety investigations for paracetamol and autism, or paracetamol and neurodevelopmental disorders more broadly.”
Speaking this morning from the White House, the president said women should not take acetaminophen, also known by the brand name Tylenol, “during the entire pregnancy.” He also raised unfounded concerns about vaccines.
The Trump administration has been under immense pressure from Health Secretary Robert F Kennedy Jr’s diverse Make America Healthy Again movement to provide answers on the causes of the marked increase in autism cases in the US in recent years.
Trump thanked Kennedy, “the man who brought this issue to the forefront of American politics, along with me.”
“We understood a lot more than a lot of people who studied it,” Trump said.
Experts say the rise in cases is mainly due to a new definition for the disorder that now includes mild cases on a “spectrum” and better diagnoses.
They say there is no single cause to the disorder and say the rhetoric appears to ignore and undermine decades of science into the genetic and environmental factors that can play a role.
The announcement is the latest step the administration, driven by Kennedy and his supporters, has taken to reshape America’s public health landscape.
Beyond cutbacks at federal health agencies, the Centres for Disease Control and Prevention has been roiled by disagreements over Kennedy’s vaccine policies.
An influential immunisation panel stocked by Kennedy with figures who have been critical of vaccines last week changed shot guidance for COVID-19 and other diseases.
‘Subject worthy of study’
Dr Nick Coatsworth told Today that paracetamol was rated category A safe for pregnancy, and that pregnant women around the country should not be alarmed by today’s announcement.
“Paracetamol is a chemical, and there’s a widespread chemical used in pregnancy, then it is worthy of study,” he said.
“So we need to say that straight up, this is a subject worthy of study.”
He said it was not the first time the link had been raised and examined, with some major birth cohort studies suggesting a “small rise” in autism diagnoses among women who consumed large amounts of the drug during pregnancy.
“I don’t think this is the odd Panadol tablet … I think that’s completely safe in pregnancy, but certainly I think this is worthy of ongoing study,” he said.
“This has been looked at before, and there are some studies which show a small risk association and many studies that do not. So we need to keep this as an open question.”
Coatsworth said the bigger part of Trump’s announcement today was the administration’s injection of US$50 million ($75.8 million) into autism research.
“There’s been objective increases in childhood neurodevelopmental issues, and we do need to research them as much as possible,” he said.
“More funding is is a good thing.”
But he expressed some skepticism over how the funding could be allocated, nodding to Kennnedy’s frequently-aired anti-vaccine opinions, which also received a push from the White House today.
Coatsworth said there was “overwhelming evidence” that childhood vaccines were not linked to autism.
But in the meantime, he said, pain and fever in pregnancy still needed to be treated and paracetamol remained the recommended response.
“These studies will be ongoing. And for pregnant women out there who are suffering from pain today, paracetamol remains the drug of choice in pregnancy,” he said.
This is a breaking news story. More to come …