Portugal’s national medicines authority, Infarmed, has denied claims made by U.S. President Donald Trump that paracetamol, when taken by pregnant women, can increase the risk of autism in the unborn child.
Trump made the claim alongside anti-vaccine advocate Robert F. Kennedy Jr., though he did not present scientific evidence to support it.
“Taking Tylenol is not good — I’ll say it: It’s not good,” Trump said, suggesting that communities without access to the medicine have “no autism,” while in others, autism now affects one in 12 boys.
His statements have made headlines worldwide, sparking concern among health experts across the globe.
In Portugal, Infarmed clarified that there is no proven relationship between paracetamol use during pregnancy and malformations in foetuses or newborns. The authority highlighted that the European Medicines Agency (EMA) reviewed studies on prenatal exposure to the drug in 2019, concluding that results were inconclusive and that no link to neurodevelopmental disorders could be established.
“A large amount of data from pregnant women who used paracetamol indicates that there is no risk of malformations in the developing foetus or newborns,” the Infarmed statement said. The medicines authority also stressed that, as with any medication, paracetamol should be used at the lowest effective dose, for the shortest possible time, and with the least frequency necessary, and that women should always consult a healthcare professional if they have concerns.
The authority also reassured the public that safety monitoring of paracetamol and other medications will continue across the European Union, and regulatory action will be taken if new evidence emerges.
Infarmed’s stance aligns with other health experts across the globe, including the UK Health Secretary and the American College of Obstetricians and Gynaecologists, who have stressed that paracetamol remains the safest over-the-counter option for treating pain and fever during pregnancy, and that the causes of autism are complex, with no single factor identified.
“I trust doctors over President Trump, frankly, on this,” said UK Health Secretary Wes Streeting.
Meanwhile, Dr Steven Fleischman, head of the American College of Obstetricians and Gynaecologists, insists that Trump’s claim “is not backed by the full body of scientific evidence and dangerously simplifies the many and complex causes of neurologic challenges in children”.
“Studies that have been conducted in the past, show no clear evidence that proves a direct relationship between the prudent use of acetaminophen during any trimester and foetal developmental issues,” he said.
Even the US Food and Drug Administration (FDA) used milder language than Trump in a notice to doctors. While the agency said doctors should consider limiting the use of paracetamol, they should also take into account that it is the safest over-the-counter option to treat fever and pain in pregnant women.
“To be clear, while an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature,” the FDA wrote.
